Links to 915 Entry-Level Biotechnology & Life Science Jobs

We are seeking an experienced, collaborative and adaptable individual to join our 10X sequencing core team. The candidate will have a strong background in nucleic acid quantification and NGS workflows. Ideally this candidate will also have an understanding of Illumina NGS or other sequencing experience. Individuals applying for this position must be self-starters, flexible in changing direction and methods, thrive in a fast paced, high throughput environment, excel at managing multiple priorities, able to effectively communicate with all levels within the organization and have the prior work experience needed to quickly learn the protocols.

4DMT is in need of a talented and motivated Research Associate (Contract) to join our R&D team in supporting our viral drug therapy research efforts as we contribute to the future of gene therapeutics. This position will combine modern molecular and cell biology methods to help streamline 4DMT’s proprietary discovery platform. This individual will work closely with the Discovery group, but is expected to be a collaborative team member within R&D.

4DMT needs a motivated, detail-oriented, and experienced Sr. Research Associate I/II. This individual will join a growing Cell-Based Assay (CBA) team to develop, optimize and validate cell-based bioassays for the characterization, lot release/stability testing and formulation assessment of AAV-based gene therapy drug substances and drug products. Sr. Research Associate I/II will interface with Research, Discovery, Process Development, Manufacturing, Quality, and Facilities functional groups as well as external parties (CRO, CDMO) to support life cycle of bioassays for current and new candidates during early- and late-stage GMP production. This is a CMC position, and the level will be determined based on the candidate’s experience and qualifications.

This position performs entry-level activities which will include 70% time in lab troubleshooting PCB, cables, using scopes, and other diagnostic tools. Willing to perform runs on the system multiple days in a row. Solve problems independently. Applies a high level of technical support in a specialized discipline using knowledge and theory of electronics; life science; chemistry; mechanics; software; etc. Understands and uses knowledge of other disciplines. Uses computer applications as needed for functional specialty. Advanced skills in computer hardware and /or software applications. Document lab activities and troubleshooting. Accepts non-routine and complex assignments. Follows established procedures Uses judgment and makes choices on how to proceed. Assignments often require creativity. Researches; recommends; and implements appropriate changes for process improvements. Uses information from within and/or outside the organization when necessary. Reads; understands and instructs others in the use of manuals; test procedures; and documentation associated with specialized equipment. Reads; interprets; and may create engineering drawings; schematics, and complex test procedures. Writes basic procedures and technical documents. Working knowledge and use of complex tools and equipment specific to functional areas. May use statistical; mathematical and other quantitative and qualitative methods and measurements. Additional time may include design and develop, construction, and evaluation of a variety of prototype Printed Circuit Boards, fixtures, and tools. Promotes the process of continuous quality improvement and risk management and coordinates solutions for technical and project issues. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises independent judgment in planning and organizing work; monitors performance and reports status. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.

The successful candidate will play a hands-on role in the company’s use of a variety of molecular biology, assay development, and protein purification techniques in support of various commercial and academic customer projects to deliver high-quality and on-time customized recombinant antibodies.

Responsible for contributing to the optimization and development of bioconjugation techniques and related processes, including but not limited to the areas of Antibody Drug Conjugates (ADCs), protein drug conjugates, conjugated vaccine,

Development, technical transfer and validation of cell based viral assays and molecular such as detection of murine, bovine, and porcine viruses, qPCR testing, barcode testing, genetic sequencing, and other methods for lot release and stability as well as Viral Clearance studies.

As a Research Associate on the High-Throughput Screening team your primary focus will be culturing genetic variants to generate material for a variety of proprietary high throughput assays. You are enthusiastic about laboratory bench work, have meticulous attention to detail, an eagerness to learn new techniques, and are comfortable working in a highly dynamic and rapidly scaling company. While work will initially be 100% E.coli based, there is the potential to expand that into mammalian cultures in the future. After training, this role will be required to work 1 set weekend day per week as part of a regular (5 day) schedule.

We are currently seeking Research Associates to join our growing purification team! Using your adept problem-solving skills, you will play a significant role in downstream process development and analytical testing of therapeutic proteins expressed using SoluPro™, AbSci’s proprietary E. coli expression platform. You will demonstrate high attention to detail, the ability to learn new skills, to work both independently and collaboratively, and be comfortable thriving in a dynamic startup environment where research targets change from day to day.

The principle responsibility of the Analytical Method Development/Quality Control (AMD/QC) Analytical Scientist is analytical support for GMP manufacturing and process development.

Entry-level position in the Reagent Lab at Accelerate Diagnostics. Research Associates are responsible for conducting regular lab operations in the support of RUO, IUO, and IVD applications. A Research Associate in the Reagent Lab will contribute to planning and executing processes under GLP and cGMP guidelines (when applicable).

General molecular biology which includes DNA cloning, site directed gene mutagenesis, plasmid DNA preparation and DNA restriction analysis. Additional responsibilities for this position may include mammalian cell culture, protein transient production, stable cell line generation and general lab maintenance.

Our Research Assistants are integral parts of teams. They support projects for clinical trials involving new drugs, biologics, devices, and vaccines, as well as behavioral interventions across a range of disease areas. A Research Assistant who is successful at Statistics Collaborative is a project team member who develops a deep understanding of the clinical trial and our responsibilities related to that trial, and who has the ability to take on more responsibility within and across projects. This is an entry-level position (0-2 years of experience) with opportunity for growth.

The essential job function is to perform physical and chemical testing of intermediate and finished products according to written procedures. This position works 12 hours shifts on a 2-2-3 schedule, for example working Monday and Tuesday off Wednesday and Thursday and working Friday, work Saturday and Sunday then off Monday and Tuesday, etc.

The essential job function is to perform physical and chemical testing of raw materials in accordance with written procedures and compendia guidelines as well as manage the paperwork associated with the control and management of raw materials.

The QC Lab Support Associate I will Perform cGMP laboratory support activities including Sample Accessioning, Product Reserve management, Temperature Monitoring of storage chambers, Glassware Cleaning, Supply Inventory management, etc. May also assist with Stability Studies and other QC initiatives. Performs all work under GMP conditions. Provide customer support to QC analysts.

Assist in the development and qualification of new immunological assays including; but not limited to, the following: Blood and mucosal sample processing, Multicolor-Flow Cytometry based assays, cytokines and other soluble biomarkers Multiplexing assays (Luminex, MSD platforms), ELISA, ELISpot, and Neutralization Assays, among others.

The R&D Associate on the Assay Development Preclinical R&D team is responsible for support of the Assay Development team by developing, qualifying and troubleshooting quantitative, semi-quantitative, and qualitative assays in support of research, nonclinical, and clinical programs.

Responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production.

Responsible for executing the day to day responsibilities related to the Drug Substance Manufacturing group under the guidance of Aji Bio-Pharma Service’s established procedures and policies.

Responsible for conducting routine analysis, inspection, testing and release of raw materials and Active Pharmaceutical Ingredients (APIs) under supervision.

Akoya Biosciences is seeking an entry level Research Associate to join our Reagents team in Menlo Park, CA. The successful candidate will join a dynamic, team-oriented environment and take part in screening of new antibodies in the CODEX platform. The desired skillset for laboratory work includes the ability to perform immunohistochemistry (IHC) procedures.

Provide scientific insight and hands on technical laboratory techniques. Coordinate laboratory operations, workloads and projects tasks. Provide scientific and technical support, prepare written scientific reports. Execute bioassays and assist in the development of new bioassays. Participate in ongoing research efforts. Maintain laboratory notebook in compliance with good documentation practices. Perform in-house quality control testing of products Perform general laboratory and instrumentation maintenance. Participates in the design and execution of investigations and experiments associated with product development Follow through with experiments and investigations by demonstrating discipline resourcefulness and willingness to follow procedures and guidelines.

The Quality Control (QC) Scientist I, Protein, supports production of recombinant proteins. This role is primarily responsible for performing release testing and ensuring that products meet or exceed all quality specifications. This role also supports the management and execution of stability studies.

The Laboratory Technician II Technical Lead oversees multiple projects simultaneously within the GMP and GMP-S area with a focus on first time right and patient first in full conformance with Quality and EHS requirements. This role assists the buffer preparation team and supervisors as directed, and fills in when supervisors are not available (eg. after hours, during PTO, and unplanned absences).

We are seeking a highly motivated Research Associate who will help advance our preclinical scientific activities to identify and characterize proteins associated with aging and disease. The role will primarily support proteomic analysis by state-of-the-art technologies including mass spectrometry and immunoassays. Studies performed will involve cutting edge science and require innovative concepts and strategies. The position is an excellent opportunity to engage in and learn a range of techniques in a dynamic environment and rapidly progress the company’s scientific activities. This role requires dedication to drive science, ability to multitask, excellent communication and organizational skills, attention to detail, and the ability to work independently as well as collaboratively with a multidisciplinary team of scientists and research associates in a fast-paced environment. Alkahest offers a competitive compensation and benefits package, annual bonus potential, opportunities for career growth and development, and a work environment that is collaborative, collegial and lots of fun.

The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks.

A successful candidate in this position will be able to multi-task and thrive in a high paced atmosphere. The Quality Control Analyst I is responsible for in-process component and final kit testing associated with ALPCO kits. This employee will develop familiarity with a variety of expectations, concepts, practices and procedures within the field as well as established laboratory concepts and practices. A Quality Control Analyst I performs a variety of tasks working under supervision. The Quality Control Analyst I reports to the Quality Control Supervisor.

ALSTEM, INC is a growing research biotechnology company located in Richmond, CA. ALSTEM is a nimble provider of tools specializing in virus packaging, genome editing, cell engineering and stem cells for life science research. ALSTEM is looking for a highly organized and energetic Research Associate with a B.S or M.S. degree to join its scientific team. The candidate will be responsible to work as a team at all levels which will include but will not be limited to product testing and QC, and custom service projects following SOPs and protocols to support customer workflows.

The Quality Assurance Specialist I support Ambry’s Quality Management System (QMS) and regulatory submissions. Responsible for processing requests, archival, filing, scanning, indexing and formatting new and existing documents within guidelines of the document control QMS procedures and the electronic document control system. Collate controlled documents and controlled records in support of regulatory submission requests, including but not limited to FDA and PMDA. Supports implementation of an electronic document control system. Possesses and applies a broad knowledge of Quality principles, practices, and procedures. Demonstrated knowledge of regulations, standards and licensure requirements, such as, clinical diagnostic laboratory standards: CAP and state licensures; Federal regulations CLIA and QMS; and Industry standards: ISO 13485 Medical Device QMS, ISO 14971 Risk Management Program, Software as a Medical Device and IEC 62304 Software Development Lifecycle.

We are currently seeking a highly motivated Research Associate / Senior Research Associate with expertise in molecular and cell biology to join the Cell Therapy platform at Ambys. In this role, you will work as part of a multidisciplinary team to develop novel therapies to treat liver diseases using cell therapy and gene therapy strategies and will be in the pre-clinical Research group developing a proprietary human hepatocyte cell therapy. This is a lab-based role where you will be responsible for conducting experiments, collecting, managing, and analyzing experimental data, interpreting results, and preparing presentations for internal and external meetings and publications. You will be under direct scientific supervision of a scientist but should be highly organized and have the self-confidence to work independently in planned studies. You should enjoy working in a fast-paced dynamic team environment and be motivated to discover new breakthrough therapies for patients with severe liver disease.

*Please Note: This position will train on the 1st shift for approximately 3 months* This position is centered on testing of raw materials, in-process, and finished product samples accurately and efficiently to determine chemical identity, potency and purity of pharmaceutical products manufactured by American Regent, Inc.

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. The successful candidate will be highly motivated individual ready to work within a science-focused, collaborative, multidisciplinary drug discovery and development environment. The Associate Scientist will be responsible for supporting lab operations in upstream and downstream protein production, viral vector production, and assay support.

The Scientist I - Quality Control is an entry-level role responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, to clearly document activities performed during testing and to calculate and report results on applicable specification documents.

The Scientist 2 is a mid-level analytical scientist opportunity supporting the analytical development of pharmaceutical oral dosage form. The individual in this capacity performs analytical methods qualifications/validations, analyzes active pharmaceutical ingredients, excipients, and finished dosage forms using appropriate analytical methods and maintains/qualifies analytical equipment.

Must use independent judgment to analyze and make determinations as to the quality of a product, using analytical equipment pertinent to the appropriate application of skills. Use various laboratory procedures related to analysis of bulk and pharmaceutical chemicals.

This position requires utilization of independent judgement to analyze raw materials, in-process, intermediate and final product, stability, and microbiology samples for the pharmaceutical industry, using various validated methodology as well as experimental ones.

Candidate will develop and validate methods; provide analytical support to the research and development group to meet project goals; select appropriate methods and techniques in performing experiments; collaborate with analytical personnel to help develop routine analytical methods; work cross functionally to achieve target goals and proactively seek out potential solutions to issues.

Amunix is seeking a Research Associate to join the analytical group to support analytical method development and quality control activities for Amunix’s pipeline. The candidate must have a strong initiative and desire to work in a fast paced, team-oriented, dynamic environment.

Perform assay kit production and QC tests: enzyme activity assays, protein expression, purification. Manage orders, maintain inventory. Perform protein labelling and conjugation procedures. Prepare product datasheets, SOPs. Manage routine activities, including meticulous record keeping. Participation in R&D projects expected. Ensure implementation, compliance, and continuous improvement of QMS through SOP documentation. Other duties as assigned by Management.

We are currently recruiting for a Research Associate to work in our regulated lab environment designing, performing, and reporting laboratory experimental tasks for the development, optimization, verification, and validation of assays to analyze nucleic acids or protein expression in human clinical samples.

Responsibilities include running immunochemistry assays (i.e. ELISA, Flow Cytometry) including all reagent and buffer preparation, assay design, and varied techniques.

Apic Bio is seeking a highly motivated Research Associate to join the Preclinical Group with a focus on translational gene therapy. Primary responsibilities will be to support in vivo studies in mice with a focus on respiratory physiology.

Provide daily support to Arrakis scientists across many departments, using state-of-the-art laboratory automation equipment and software to prepare compound plates in a wide variety of formats. The role also involves working closely with Medicinal Chemists to routinely procure new compounds from multiple vendors.

The Sr. Research Associate/Associate Scientist is a member of the Histotechnology team in the Toxicology Department. The Histotechnology team supports the Company’s preclinical drug development efforts by designing studies, collecting, preparing and analyzing samples generated by the Company’s animal studies.

The position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. An AD Scientist will support method development/validation activities for new drug substances and drug product. He/She will also support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies.

We have an immediate opening for an Associate Production Chemist in the Chemistry, Manufacturing, and Controls Group.

We are looking for an energetic, highly motivated individual who wants to work in a fast-paced, team-focused environment, within our Quality and Analytical Development Group. This individual will perform testing to support manufacturing, development and characterization efforts for our exosome products, reporting into a QC supervisor or manager. Activities include conducting a variety of cellular, molecular biology and analytical tests on raw materials, process intermediates, drug substance, drug product and stability samples.

The Quality Control Technician, Cell Therapy Development, will report to the Senior Quality Control Scientist. This position will support assay development and stem cell therapy manufacturing and release testing related to induced pluripotent stem cell (iPSC) derived dopaminergic progenitor cells of a first-in-human clinical trial for the treatment of Parkinson’s Disease.

This position provides Quality Control qualification, validation, testing support for AIRM cell therapy products. Looking for strong GMP background with method validation and quality control testing experience.

Cell Culture & Fermentation Sciences is an arm of the Biopharmaceutical Development Group. We are responsible for developing all of the clinical and commercial processes that use microbial or mammalian cells to generate therapeutic proteins. In this role you will be part of a team of highly skilled scientists working on fermentation projects using multiple microbial hosts.

This position within Cell Culture and Fermentation Sciences will involve substantial amount of hands on cell culture work to develop, scale up, and characterize mammalian culture processes. The candidate will be expected to execute experiments on a routine basis to develop and characterize the upstream cell culture processes and be familiar with the basics of DOE including screening and optimization designs.

The Temporary Research Associate I/ II will utilize his/her cell biology and flow cytometry skills to isolate immune cells and sort them into microplates in a biosafety level 2 (BSL2) environment. He/ She will also be utilizing in vitro assays to characterize antibodies. This position will work in a collaborative team environment. The successful candidate will be detail-oriented and patient in working with our delicate cell sorting machines. There will be opportunity for permanent employment based on performance.

Under the direction of the Quality Control Supervisor; responsible for working within the approved safety guidelines to test samples; responsible for chemical and/or physical analysis activities of high complexity on raw materials, in process and finished products. Prepare solutions and control results, materials and reagents. Ability to recognize and identify problems while using technical resources; basic knowledge and use of SAP and Master Control is necessary at this job level.

This is a hands-on position with responsibility for the design, synthesis, and analysis of antibody oligonucleotide conjugates. The ideal candidate will have biotech/pharma experience in aspects of medicinal chemistry, bioconjugation and nucleic acid therapeutics.

The Research Associate will support biology as a member of a highly matrixed drug discovery team and will be responsible for the execution and troubleshooting of various biological assays and experiments.

Help to establish protocols around differentiation of primary immune cells, including extensive tissue culture work (maintenance, expansion, and banking) Handling and analyzing workflows pertaining to cellular differentiation and profiling with downstream qRT-PCR, protein quantification, and other molecular readouts Cloning of constructs to support cellular engineering efforts  Detailed record-keeping and protocol refinement as related to molecular and cellular assays Facilitate efficient transfer of assays to CRO partners where applicable  

Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as the need arises. Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits. Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem. Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance. Ensure that studies adhere to FDA regulations, Good Clinical Practices, and IVD directives.

The Analytical Chemist will perform testing of compounds from small molecules, such as Cepheid proprietary chemical reagents, to synthetic oligonucleotides for use in Cepheid in-vitro diagnostic products. The test methods involve the operation of a variety of analytical equipment, including but not limited to HPLC, LCMS, and UV-Vis Spectrophotometers.

Currently looking for a Research Associate with a computational/bioinformatics focus to join our Clinical Operations team. Under the guidance and supervision of the Director of Process Engineering, this person will learn and develop bioinformatics pipelines for analysis of next-generation DNA sequencing data.

We are looking for a driven Clinical Laboratory Scientist (with California Clinical Laboratory Scientist License) to perform UNITY, the only non-invasive prenatal test (NIPT) that can detect inherited disorders such as sickle cell disease, spinal muscular atrophy, and cystic fibrosis in the baby directly from maternal blood.

As part of an interdisciplinary team, this position will support development and troubleshooting of novel polymeric reagents for cell and gene therapy research and clinical use. The role will focus on formulating new hydrogel microspheres to deliver scalable, repeatable and functional product for a variety of internal and external customer projects. Additionally, the Product Engineer will contribute to developing new chemical, imaging and cell based analytical tools with opportunity to collaborate with technical groups across Bio-Techne. You’ll join a strong and fun team of biologists, chemists and engineers focused on developing next generation tools for immunotherapies and research, with great opportunities to develop your technical and intellectual skill sets in a highly dynamic and interactive environment. We are looking for an individual who is highly motivated, organized, with a positive can-do attitude, and the flexibility to support a variety of company activities and projects, such as lab management and product manufacturing. Prior polymer science or materials engineering experience research experience is desirable.

This position will serve as key member of the ACD Professional Assay Services (PAS) department, performing RNAscope assay services for industrial, pharmaceutical, and academic clients. The position will have an opportunity to work closely with scientists and investigators from a broad customer base. The Research Associate must be willing to learn new techniques quickly and be able to adapt to shifting priorities in a fast-paced and growing start-up environment. This position will be based in Newark, California.

We are currently looking for an enthusiastic research associate to join our manufacturing team. This position will entail preparing reagents for our assay kits, QCing, and packaging the finished products. This candidate may also join part time in our R&D team.

The Template Control Research Associate (RA) works with a team that formulates DNA and RNA template control components to support the company’s in vitro diagnostic products’ research and development, manufacturing, validations, and quality control efforts. The RA-I will use established methods and techniques to maintain the lab’s DNA and RNA template inventory, perform template manipulations and verification including diluting, aliquoting, mixing, quantitative PCR, quantitative RT-PCR, and FilmArray analysis, perform template and control mix formulations, and dispense template and control mixes to dependent departments in accordance with the company’s quality system. The RA-I will receive general instruction on routine work, perform lab duties with minimal supervision, and receive training and additional instruction for new tasks as needed. Substantial preference will be given to candidates who hold a B.S. in chemistry, biology, or a related field, but exceptional applicants with an Associate’s degree will be given consideration. Strong pipetting skills, attention to detail and organization, and familiarity with Excel and Word are required. Previous lab experience is desired, and familiarity with bioinformatics programs and cGMP compliance is a plus.

The RA will be responsible for supporting scientific staff in daily processing samples. This person will also participate in execution and optimization of current protocols in the commercial development team. The RA will aid the other laboratory functions such as reagent preparation, cell staining, cell isolation and general laboratory technical support. The successful candidate must be willing to take on new responsibilities and vary work schedule to accommodate company needs, this may require occasional long work days.

We are looking for people to do some data confirmation tasks. Mostly checking Google, Company Websites & LinkedIn to confirm the info we have is accurate. Must be able to accept payment via PayPal. If interested, send a message through the contact form. Thanks!

The Associate Scientist – Quality control at MilliporeSigma will be responsible for performing Quality Control microbiology activities in support of GMP products, including routine testing and peer review of raw materials and finished products.

At EMD Serono, the Associate Scientist – Medicinal Chemistry will contribute to the achievement of drug discovery project goals through the synthesis of target molecules by applying modern organic synthetic methods and following best medicinal chemistry practices.

The Quality Assurance Specialist provides training and quality-related guidance to Bio-Techne’s staff through extensive understanding of compliance standards and governing bodies. This position will lead quality assurance best practices and work with department leaders to implement improvements. Prior quality assurance experience within a similar industry, as well as strong attention to detail are key attributes to being successful in this role.

The responsibilities of this position are to perform ELISA assays to check for quality performance of product, maintain accurate documentation of results, and maintain assay databases. This position will perform quality control testing of Quantikine ELISAs, Luminex assays, IVD kits, and related product lines.  Formulate solutions for production and raw material testing as needed.  Perform raw material qualification testing as needed.  Calculate data and compile results efficiently. Troubleshoot assay problems and collaborate with others.  Assist in transfer of new products from Development. Perform general lab duties as needed.  Within this job function, the Senior Research Associate must also pursue annual goals that aim to facilitate innovation, efficiency, productivity, and team building across the QC Department or the entire company.The responsibilities of this position are to perform ELISA assays to check for quality performance of product, maintain accurate documentation of results, and maintain assay databases. This position will perform quality control testing of Quantikine ELISAs, Luminex assays, IVD kits, and related product lines.  Formulate solutions for production and raw material testing as needed.  Perform raw material qualification testing as needed.  Calculate data and compile results efficiently. Troubleshoot assay problems and collaborate with others.  Assist in transfer of new products from Development. Perform general lab duties as needed.  Within this job function, the Senior Research Associate must also pursue annual goals that aim to facilitate innovation, efficiency, productivity, and team building across the QC Department or the entire company.

This position is responsible for purifying polyclonal/monoclonal antibodies in a GMP Lab, following GMP guidelines. This includes, but is not limited to GMP, other products used by pharma and IVD customers. Purifies polyclonal/monoclonal antibodies by column chromatography, using a variety of techniques and equipment. Filter, aliquot, and bottling of product using aseptic techniques, and submits to bulk inventory. Documents batch records following GMP guidelines.  This person will be expected to either work a Sunday to Thursday or Tuesday to Saturday shift.

A Research Associate is responsible for development of cell culture protocols for new recombinant protein products. This includes screening clones and testing growth conditions in bioreactors and other culture formats, in small to medium scale. It may also include cooperation with the molecular biology group in creation of new clones and clone libraries, creation and characterization of new cell lines, and screening studies in search for novel protein product targets.

This role will be responsible for scale-up of protein purification processes in order to generate milligram to gram-scale quantities of recombinant proteins to support life science reagent manufacturing. The successful candidate will be highly proficient in recombinant protein expression and purification from various host cell systems (e.g. E. coli and mammalian cells).

The Medical Technologist I performs tests requiring the exercise of independent judgment and responsibility in those specialties in which the Technologist is qualified by education, training and experience.

The successful candidate will have hands on experience in Immunology and immune cell biology. This individual will join a team of scientists to engineer novel immune cell therapies derived from induced Pluripotent Stem Cells (iPSC) for the treatment of inflammatory or autoimmune diseases.

The candidate will be a key technical contributor of a dynamic and progressive team pioneering scaled somatic cell manufacturing processes utilizing state-of-the art culturing technology at increasing scales. The successful candidate will drive assay discovery and development at BlueRock, NY, establishing critical characterization and quality assays for cell therapy products and manufacturing processes with minimal supervision. Expertise in cell and molecular biology is required.

The successful candidate will be a key technical contributor of a dynamic and progressive team developing novel therapeutics. This challenging opportunity requires in depth knowledge of neurodegenerative diseases as well as stem cell biology. The ideal candidate will be a highly motivated individual who leads from the bench and enjoys having broad responsibilities and opportunities.

Performs clinical laboratory procedures and examinations and any other tests or procedures conducted by a clinical laboratory, including maintaining equipment and records, and performing quality assurance activities related to examination performance, and which require the exercise of independent judgment and responsibility, as determined by the department.

This position will support the identification of potential biomarkers and patient populations, target engagement, and pharmacodynamic assays for oncology targets. Additionally, the position will support mechanism of action studies using primary human tumors and mouse models and platform development and validation studies for TME biology. The qualified candidate is a highly motivated, collaborative, and creative individual th

Under the general supervision of a group leader, the QC Analyst I will perform various analytical techniques to determine isotopic enrichment, chemical purity, concentration and identity testing on a wide array of stable isotope-labeled materials (13C, 15N, Deuterium, and 18O isotopes). The role will focus primarily on NMR (1H, 2H, 31P, 19F, qNMR), GC, and wet chemistry analyses of solutions and neat materials, in support of the CIL production chemists, Operations & Logistics group and ISO 17025 reference materials program.

The incumbent be part of a GMP/ISO environment responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components.

Under the supervision of a group leader or supervisor, the Associate Chemist will work alongside an experienced scientist executing syntheses of isotopically labeled (13C, 15N, 18O and D isotopes) targets utilizing highly detailed SOPs and procedures.

CIL Process Technicians work in a team-based environment and are responsible for safety, production, maintenance, and product quality. Technicians are expected to understand and use automated control systems, production machinery, and laboratory equipment. Ability to work unsupervised and a willingness to succeed is required.

We are seeking a Sequencing Research Associate to join our Molecular Engineering group. In this role, you will run and maintain a custom sequencing and genomic detection pipeline. The ideal candidate will interact closely with Scientists and other RAs to support sequencing and cell-based screening activities and will participate in the design and implementation of automated workflows.

The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.

The Manufacturing Associate I (Cell Therapy) is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of cell therapy production and/or human cells cultivation. The Manufacturing Associate I (Cell Therapy) role is critical to our patients. Manufacturing life-saving medicines right the first time for themselves and their team with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role!

Catamaran is seeking an experienced, hands-on Senior Research Associate / Research Associate to join the development team in assembling a state-of-the-art manufacturing process for our allogeneic NK cell drug product. The successful candidate will be responsible for optimizing our cell processes for NK cells, including cell isolation, engineering, expansion, harvest and cryopreservation.

The TCC team is responsible for maintaining a reliable cell line bank and generating high quality lysates for the CST Production department.

We are seeking an experienced Research Technician for our Toxicology Team located in Spencerville, OH. A Research Technician is responsible for: administering substances to animals, performing husbandry duties, including cleaning/transporting caging and providing food and water; performing clinical observations of animals to determine morbidity/mortality; collecting and handling data and specimens; euthanizing animals and assisting veterinarians, management, and other company personnel with animal care, study-related tasks, and process improvement initiatives. The training and development offered to our entry level technicians is state of the art and designed to help you succeed. The work you will be doing will impact the lives of patients and animals across the world.

This is an entry level trainee position for a Study Director/Scientist within the Safety Assessment division of Charles River Laboratories, Inc (CRL). A Study Director/Scientist has overall responsibility for the technical conduct of studies according to FDA or other applicable guidelines and Good Laboratory Practice (GLP) regulations. With guidance from senior scientific staff, serve as a Study Director in the direction and execution of assigned non-GLP and GLP studies as they apply to the conduct of preclinical research. In preparation to become a Study Director the objectives during this training period will be to ready the individual to be overall responsible of protocols/study plans, study schedules, Standard Operating Procedures and familiarity/awareness of study cost estimates. Overall interpretation of preclinical toxicity studies, evaluation and preparation of reports from the data collected during these studies, communication with sponsor representatives, initiating contact with potential clients, and may be involved with development of new technologies/procedures.

We are seeking a Research Assistant I for our Safety Assessment Group site located in Ashland, Ohio. Generate and record data with minimal supervision in the performance of studies. Responsible for handling and processing samples, and performing accurate data collection and reporting. Perform laboratory tasks by various basic methods.

We are seeking a Discovery Bioanalytical Research Associate (DMPK Bioanalytical) for our Discovery site located in South San Francisco, CA. We are seeking Research Associate candidates that are early in their careers and are highly motivated, enthusiastic and possess a passion for learning. This position will be involved in all aspects of studies supporting the bioanalysis of drug molecules in multiple matrices. This position is ideally suited to recent graduates who enjoy a fast-paced and collegial environment. The individual in this position will be responsible for working hands-on and under the direction of more senior staff in a dynamic environment where teamwork, data quality, innovation and speed are valued.

This position will support the downstream purification team for development and implementation of a fully integrated end to end continuous bio-production platform fully enabled with PAT. This position will focus on evaluating continuous operation technologies using quality by design techniques, to develop and optimize novel, continuous recovery and purification processes, for recombinant proteins and biological macromolecules. The applicant should have experience in laboratory research, and a desire to continue in a laboratory-focused role. The position will interface with a small team of scientist and engineers focused on continuous chromatography process development and technology transfer to demonstration scale production.

We are looking for a highly motivated and dynamic candidate for the role of Research Associate, Cellular & Molecular Neurobiology to join CODA’s pharmacology group. This individual will work under the guidance of a scientist to support selection and characterization of engineered ligand-gated ion channel candidates via in vitro imaging and electrophysiology assays. The ideal candidate has significant experience in neuronal primary culture, including tissue harvest, cell culture and in vitro viral vector transduction systems, and is open-minded, trainable, and enthusiastic about research.

Codexis Biotherapeutics is rapidly growing, and we are presently seeking to expand our pipeline and diversify applications of our technology platform. To help us meet these goals, we are looking to hire a Research Assistant/Associate to join our Biotherapeutics Lead Discovery Team.

Review manufacturing Batch Production Records (BPRs) and associated supporting documentation including logbooks, Quality Control (QC) testing reports, environmental monitoring reports, etc. Perform line clearance and provide general manufacturing support. Supports product shipment and receipt of returns. Support raw material review and disposition. Review Building Management Systems reports. Participate in departmental and cross-functional continuous improvement efforts. Consistently set a high standard for quality of work. Promote a safety mindset through daily actions and communication with team members. Other duties as assigned.

The Manufacturing Associate I is responsible for performing various manufacturing activities related to the start-up and GMP production of a number of novel cellular products including compliance with regulatory agencies and associated guidelines. Must be able to work night, weekends, and holidays, as necessary. Must be able to meet physical requirements established in this job description.

The ideal candidate will be interested in developing creative and novel immunology-based assays for solving complex biological problems, as well as developing an understanding of therapeutic drug discovery and its applications, related to treatment of immunological based diseases including cancer. The Associate Scientist will have strong interpersonal skills and enjoy working in a truly multi-disciplinary environment, while interacting closely with colleagues and being trained by more senior scientists, in multidisciplinary teams such as immunology, platform technology, and protein engineering

Performs complex molecular-based procedures on clinical samples. Analyzes clinical results and provides diagnoses. Performs clinical tasks associated with clinical cases.

Performs all technician tasks accurately and efficiently without supervision. Initiates expert technical advice to customers and completes all tasks in the Technician Training manual. Maintains a high level of housekeeping and attention to detail.

Analyzes biological or chemical samples and/or develops/validates methodologies for various compounds and components in compliance with standard operating procedures (SOPs) and regulatory agency guidelines.

No professional experience required. You will be performing basic necropsy or histology tasks on a variety of laboratory animals in compliance with the appropriate Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs) and regulatory guidelines.

Crinetics Pharmaceuticals is seeking a highly motivated professional to perform analytical functions for active pharmaceutical ingredients (API) and drug product (DP), joining its growing and dynamic team. This job will report to the Director, CMC Analytical. The Chemistry, Manufacturing and Controls (CMC) team is highly collaborative with a global network of highly qualified Contract-Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs). This individual will be an integral part of the company’s effort to discover and develop small molecule therapeutics for rare endocrine disorders and endocrine-related-tumors.

Develop novel gene editing therapies for serious diseases. Integral in discovering, developing, and characterizing the next generation of genetic therapies for a wide range of indications.

The purpose of the Cancer Biology Immunology - Research Associate I is to provide support with in vitro client studies and help with in vivo studies aligned with company's goals, objectives and quality standards.

The purpose of the Inflammation and Immunology Research Associate I position is to perform primarily in vivo animal studies within the Inflammation and Immunology group in support of the Company's goals and objectives.

The Associate Scientist hired for this position will support development and testing of molecular biology assays, such as qPCR, RT-PCR, digital PCR, for the process development of seasonal and pandemic DS and DP and execution of development stability studies.

The QC Assistant is responsible for inspecting and reporting on material processes and products; performing and documenting visual, dimensional and functional inspection of in-coming raw material, intermediate material and finished product; responsible for some QA related work for maintaining and improving the quality management system.

We’re looking for a Research Associate I, Analytical Chemist who will be responsible for transferring and validating analytical methods for customer products, troubleshooting analytical equipment with minimum supervision and writing validation reports. In this role, you will impact our cloud based analytical services to accelerate the product quantification which allows our clients to make faster decisions about their product. This is a great opportunity for someone looking to grow to join a team willing to train and leverage their analytical chemistry skills.

The Technician II (Synthesis) synthesizes custom oligonucleotides according to the customer�s order. This generally includes synthesis, cleavage, deprotection and QC sampling of the products being made. The Technician II (Purification) purifies custom oligonucleotides according to the customer�s order. This generally includes the sorting, purification, and QC sampling of the products being made. The Technician II (Formulation) formulates custom oligonucleotides according to the customer�s specifications. This generally includes quantification, final packaging, and QC sampling of the products being made.

The Technician II (Small Molecule Chemistry) is responsible for the preparation of quality raw materials for the production of oligonucleotides.

Responsibilities: Visually inspects and reviews products prior to shipment to ensure it meets customer specifications. Verifies GMP orders by confirming information from multiple sources, ensuring 100% compliance via an oligo master record with final signoff upon order verification. Troubleshoots any order issues identified during post synthesis review that may prevent shipment. Makes independent decisions regarding a product�s path based on individual attributes of the product and customer requirements. Reviews and documents procedures used for each product in custom software or by other controlled methods.

The Bioinformatics Scientist I, under minimal supervision, will support a group of experienced scientists to develop novel genomic applications. �This individual will be a contributor to the product development team and report to their Bioinformatics group leader.

We are seeking a Research Associate/Senior Research Associate to support our proprietary drug discovery platform. The candidate will be joining DeepBiome’s synthetic biology group and working in a cross-functional project team. Types of activities include plasmid construction and preparation, transformation and culturing, plus preparing experimental media and buffers.

Demetrix is a start up in the San Francisco Bay area that is making nature’s medicines in a smart and responsible way. We are seeking an Associate Scientist to join the Strain Engineering team. The individual in this role will be part of an interdisciplinary team of molecular biologists, fermentation scientists and engineers, automation engineers, software engineers, and analytical chemists working to rapidly develop microbial strains to produce natural product medicines. This is a full time position.

Demetrix is a three-year-old start-up in the San Francisco Bay area that is making nature’s medicines in a smart and responsible way via synthetic biology. You will be part of the Downsteam Process Development team and will assist in the development of robust, scalable downstream processes at bench-scale, and transfer these processes to pilot and manufacturing scale. You will be part of an interdisciplinary team of fermentation engineers, automation engineers, software engineers, analytical chemists, and molecular biologists working to rapidly develop microbial strains to produce natural product medicines.

Reporting to Laboratory Manager, under supervision of licensed personnel, the MLT will prepare samples in the pre-Analytical phase to be processed by the CLS and functions as support for other laboratory functions.

Bioproduct Analytical Development has an exciting opportunity for an analytical chemist to join our control strategy development group! You will be part of a diverse team of analytical chemists, pharmaceutical scientists, and purifications engineers delivering product and process understanding across a broad range of platforms. Candidates for this position will be able to: Development of analytical methods to support development of oligonucleotides, therapeutic recombinant proteins, and/or our bioproduct large molecule portfolio. Participate in the development of the control strategy for the development of oligonucleotides, therapeutic recombinant proteins, and/or our bioproduct large molecule portfolio. Responsible for evaluating and/or implementing new analytical technologies/methods to advance Lilly's current analytical capabilities for bioproduct testing with a focus on state-of-the-art separation sciences capabilities. The ideal candidate will have breadth in multiple analytical techniques. Strong technical problem-solving ability and the ability to work with cross-functional teams will be required.

We are the Biotechnology Discovery Research Division at LBC-San Diego, responsible for generating, characterizing, and optimizing biotherapeutics from lead generation through lead optimization and preclinical development. Individuals on our team support cross-disciplinary efforts to engineer innovative biotherapeutics that treat metabolic, autoimmune, and neurologic diseases. Join our team of scientists working to improve lives of patients around the world. The Protein Biosciences Group at the Lilly Biotechnology Center-San Diego is seeking an associate level scientist specializing in molecular biology to join the Mammalian Protein Expression Team. We are looking for a hardworking scientist who is organized, detail-oriented and passionate about research. Do you have an in depth understanding and experience in molecular biology techniques to execute custom cloning project? Join our team and grow in your career!

An integral part of the R&D team, the Research Associate (RA) will have the opportunity to work with the team to explore new technologies and assist in the development of molecular diagnostic tests in DermTech’s current and future product pipeline. The RA will conduct laboratory tests that generate high-quality data to support the development of molecular diagnostic tests.

We are searching for a creative and experienced Research Associate or Senior Research Associate to help build Dewpoint’s novel technology platform. You will play a pivotal role in developing and executing cellular and biochemical assays to characterize disease-relevant condensates, and to discover novel condensates with critical roles in disease.

Dicerna Pharmaceuticals is seeking a highly motivated Research Associate with a strong background in synthetic and medicinal chemistry to join the Chemistry Team. The candidate will be responsible for the synthesis of oligonucleotide conjugates, nucleoside analogues, small molecule ligands, and linkers. This position will contribute to the development of novel nucleic acid conjugate platforms and support therapeutic programs in multiple disease areas.

Key responsibilities for this role include: Responsible for providing guidance and feedback to both internal and external customers to ensure Quality Systems requirements are met. Supports Quality Systems investigations and the facilitation of review/closure of associated records, including corrective and preventive actions (as applicable). Perform final Quality Systems review and release of raw materials/components. Facilitate change control records and their associated action items for implementation and closure. Place and maintain Quality holds (product, controlled documents, test standards) as required. Provide support for maintaining weekly/monthly internal Quality metrics Support internal, client, and regulatory audit requests as required. Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations. Perform other duties as assigned

Key responsibilities for this role include: Perform testing and inspections of various components, intermediates and finished products. Develop expertise in physical and chemical testing of adhesives and adhesive products. Assist in the development of analytical methods. Document activities and check documentation of other laboratory personnel. Assist in the investigation of aberrant results. Provide written summary reports of such investigations. Calibrate laboratory equipment as necessary. Draft protocols, technical reports, changes to SOPs, STMs. Train new laboratory personnel on test methods as required.

Dropworks is seeking a Research Associate with experience in PCR-based assays to join their team for the development of an exciting new digital PCR platform. This position will be responsible for designing, executing and analyzing experiments on their digital PCR system to aid in assay and product development. Ideal candidates will display an inquisitive nature, good time management and have a strong attention to detail. This position will require clear communication and frequent interaction with cross-functional team members, including significant exposure to an engineering environment.

Testing biological specimens in molecular biology laboratory environment, including high throughput workflows, analyzing the results, and preparing them for reporting.

DxTerity, a patient-centric genomics company located in Los Angeles, CA is looking to hire a Research Associate to join our Research and Product Development team. Responsibilities include: development of molecular diagnostic test kits, reagents and procedures in a team environment. Perform experiments independently after receiving general direction from supervisor. Make detailed observations, analyzes data and interpret results.

Estimate, plan, and coordinate testing activities. Develop test plan, test cases, test scenarios based on Users Stories and product’s design description to meet business requirements and technical specifications Perform ad hoc, functional, integration, and regression testing Identify software defects and submit problem reports via bug-tracking system Perform regression testing on fixed issues

Responsibilities: Estimate, plan, and coordinate testing activities. Develop test plan, test cases, test scenarios based on Users Stories and product’s design description to meet business requirements and technical specifications. Perform ad hoc, functional, integration, and regression testing. Identify software defects and submit problem reports via bug-tracking system. Perform regression testing on fixed issues.

Eurofins Lancaster Laboratories PSS is searching for a Molecular Biologist Associate to work with Automation/High-Throughput technologies in San Diego, CA.

Develop, qualify and validate analytical test methods for drug product, intermediates and excipients Design and execute analytical development studies Write analytical method validation protocols and reports Write and maintain applicable SOPs Provide analytical support to QC, Process Engineering and Manufacturing as applicable Perform externally generated data review Assist in development stability study design and protocol writing Assist management during regulatory inspections and internal audits

Editas Medicine is seeking a highly motivated Research Associate I/II to join our team and advance Editas’ cell-based medicines portfolio. In this role, you will contribute to generate pre-clinical and clinical genetically engineered induced pluripotent stem cell (iPSC) lines and develop a clinically compatible, cutting-edge platform to edit, isolate and characterize clonal cell banks. The ideal candidate should have a background in gene-editing, cancer biology and a solid cell culture experience. Automation of cell culture, including the use of liquid handling robots and microplate handlers will be involved. The successful candidate will perform his/her responsibilities both at the Cambridge location and at a cleanroom in Waltham and will interact with the Sequencing, Quality and CMC/manufacturing teams as well as iPSC differentiation and genotoxicity groups. The successful candidate should demonstrate strong work ethic and enjoy working in a fast-paced and team-oriented work environment.

Elektrofi is looking for a Research Associate to join a team responsible for the development of platform formulations for Elektrofi’s proprietary microparticle production process. The Research Associate will play a key role in supporting the development of its biologics formulation platform. This individual will join an earlystage, multidisciplinary team of scientists and contribute to a variety of formulations activities in a highly collaborative environment.

We are seeking a highly motivated team player and fast learner to join our team. Good communication and organization skills are required, as well as the ability to multi-task to deliver results within a timeline.

This position seeks an exceptional candidate with a deep understanding of algorithms and strong scientific software development skills. The work environment provides a variety of projects with an opportunity to work on product design and green-field analysis infrastructure. You will design and implement innovative algorithms for the analysis of high throughput data. You will work as part of a cross-disciplinary team on the foundational aspects of an exciting, new technology. Your work will directly drive technology improvement and become a part of the customer-facing offering.

Element is seeking a scientist contributor to work with cross-functional departments to understand enzyme requirements and build assays and characterization tools to determine if enzymes meet specifications. This position requires the technical expertise and drive to work independently and in combination with a small team to deliver understanding and mitigations to enzyme performance and stability.  Characterization methods will employ both solution-based and surface interaction-based studies. The Assay Scientist develops advanced methods/techniques for testing and evaluation and will provide project leadership, technical consultation, work direction, and training to junior personnel. Must be comfortable working without appreciable direction on assigned projects/programs and assisting in determining objectives of assignments.

Responsibilities: Design and conduct hypothesis driven experiments. Implement and maintain process workflows and good work practices. Support the optimization of reagents for our new NGS technologies. Write and version SOPs and work instructions. Collaborate closely with upstream research teams and downstream ops/manufacturing teams as products evolve. Analyze data, record, and present results.

The chemist performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. The chemist completes second person verification of others results.

The Chemist � QC � IAPI performs accurate and timely testing of routine lab samples in accordance with appropriate GMP and safety guidelines. The Chemist � QC - IAPI also participates in second person verification (SPV) of analytical data, laboratory investigations, equipment calibrations and maintenance by executing well-defined protocols and procedures.

The primary responsibility is to perform routine release testing of raw materials (Active ingredient, excipients, colors,) and packaging materials in accordance with established procedures (in-house, Pharmacopeial, vendor procedures)

The Research Assistant will assist in the development and characterization of stem cell, cell sheet research and anti-cancer drug for the treatment of rare diseases. This individual will work under the supervision of the Principal Investigator and will have an excellent opportunity to gain life sciences lab experience in a stateof-the–art research environment. This position is primarily located in the laboratory with occasional office work required.

Empirico, a human genetics-focused biotechnology company, is looking for a laboratory assistant to help with routine laboratory operations. This is an excellent opportunity to gain hands-on experience working at a highly innovative biotechnology company and with experienced scientists that have a passion for finding novel approaches toward the treatment and prevention of disease

The Contracts Coordinator will be responsible for assisting the Legal team with contracts and related responsibilities.  This is an entry level position reporting to the Senior Director, Contracts Management in the Legal Department. The Contract Coordinator will work with all members of the Legal team, as well as staff across the company.

Encodia is seeking to recruit a BS/MS level Research Associate with 2 - 5 years of experience in production and QC of microbead materials. The successful candidate will possess excellent lab skills in performing R&D and production operations consistently and hands-on experience in analytical tools for assessing materials and surfaces. This position will involve research and collaboration with teams that interface between material science, chemistry, and bio-conjugation on solid supports. Highly motivated candidates with a passion for innovation are encouraged to apply.

The Manufacturing Associate II, Upstream Processing works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture collagenase clostridium histolyticum bulk drug substance (CCH BDS). This role authors and revises manufacturing and process equipment documentation and is responsible for supporting necessary fermentation and production activities, including validation and development work as needed. 

The QC Analyst II - Chemistry will provide bioanalytical expertise for the Quality Control (QC) department. Key areas of focus are development and implementation of the quality aspects of late stage or marketed product strategy. This role is involved with performing and assisting with OOS investigation and resolution. Additionally, the Analyst II will have responsibility for coordinating the bioanalytical technology transfer from outside departments and to outside contractors.

The QC Analyst I – Microbiology will perform microbiological testing, release of in-process, intermediates and finished products, and testing for validation purposes. This role completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms. Additionally, this role is responsible for assisting with the writing of standard operating procedures (SOPs) and revision of existing documentation.

The Quality Engineer, reporting to the Director, Quality Management, is a driver of exceptional product quality, reliability, and security through directly influencing Product Development, Operations, and IT builds. This individual actively participates in risk management, design controls, design for quality, design for maintainability, design for supportability, and product validation. They ensure upper management is apprised on the performance of the quality management system and any need for improvements. The quality engineer also promotes awareness of regulatory and customer requirements throughout the organization and leads focused quality projects, as required, to resolve problems or make improvements to specific processes.

Entrada is seeking a highly motivated, collaborative, and innovative research associate with a background in antibody discovery and engineering to join Entrada’s discovery efforts. The candidate will work with world-class, multidisciplinary team of drug discovery scientists on applying cutting-edge delivery technology to develop leads for compelling intracellular biological targets. Specifically, the candidate will execute biologics against therapeutically relevant intracellular targets and contribute to scientific publications and regulatory submissions as required.

In this position, you will be part of a cross-functional team exploring new therapeutic programs for neuromuscular and cardiovascular disease areas. You will play a critical role in the development and execution of molecular and cellular biology experiments which are critical to the success of Entrada's drug discovery programs. You will utilize cell-based disease models, and techniques such as PCR, Western blot, cell and tissue culture, and immunostaining (IHC, IF).

In this role you will be responsible for designing and executing the synthesis and purification of peptides and oligonucleotide development candidates. You will also integrate and execute analytical characterizations of peptide and oligonucleotide libraries using liquid chromatography techniques and LC-MS. Along with these responsibilities, you’ll also be responsible for maintaining good written records of laboratory procedures, data analysis, and generate high-quality study reports, performing routine instrument maintenance and buffer preparations. You should be excited to interpret and present your research findings at scientific meetings.

This position is responsible for the manufacturing and testing of immunoassay kits, chemicals, and reagents serving the life sciences, and ensuring product quality based on thorough science. Integral to the kit production process, the Manufacturing Scientist I will assist in all phases of kit product release, including the choice of critical raw materials, selection of release criteria, and the validation, testing, and optimizing of kit components. As part of the manufacturing team, this position will share matrixed responsibilities with team members to meet kit production goals.

This position is responsible for the planning, implementation, and maintenance of manufacturing methods, processes, and operations for current and new product lines, as well as contributing to the improvement of production capabilities. The Associate Manufacturing Scientist is also responsible for understanding product specifications, troubleshooting technical problems, and implementing process improvements.

This position is responsible for the timely and efficient scheduling and packaging of standard and custom products, and for providing support to other areas of manufacturing to ensure timely product delivery. 

Responsibilities: Collaborate with product management and engineering to define and implement innovative solutions for the product direction, visuals and experience. Execute all visual design stages from concept to prototype. Create simple and intuitive experiences by distilling product requirements and user goals into sketches, wireframes, and prototypes and continuously iterating to meet customer needs. Designing original pieces, including illustrations and infographics and presentation decks Contribute to and help evolve ERT’s design system and individually contribute on an array of projects that use the design system.

This position will be responsible for supporting SIMS Scientist activities by preparing samples and equipment for analyses, including but not limited to, mounting, machining, and polishing techniques

The candidate for this position will lead and perform cell biology/cell culture process development in support of the Drug Product Development in Spring House, PA.

Maintain GC/MS instrumentation Tune and calibrate instrument daily Analyze quality control and client samples Review and assemble data in an efficient manner with a high degree of quality Evaluate current organizational and analytical systems Suggest and implement the necessary corrective action to ensure the above can be performed in alignment with client and/or regulatory requirements Perform all duties with minimal supervision

The successful candidate for the Scientist I position will join the Profiling and Cell Services team with a multifaceted approach for providing high value services based on the DiscoveRx PathHunter platform and other proprietary technologies.

Experience executing bioassays (cell culture related assays) and binding assays in a regulated environment Proficiency in diverse analytical techniques is required along with basic biochemistry laboratory techniques Computer competency is essential with emphasis on spreadsheet-based software. The ability to adhere to strict guidelines when applicable is required. Ability to document and review data as per established company guidelines and SOPs Expected to be able to work as a team player and take initiatives on lab management/maintenance tasks

Associate Chemist responsibilities include, but are not limited to, the following: · Maintain GC/MS instrumentation · Tune and calibrate instrument daily · Analyze quality control and client samples · Review and assemble data in an efficient manner with a high degree of quality · Evaluate current organizational and analytical systems · Suggest and implement the necessary corrective action to ensure the above can be performed in alignment with client and/or regulatory requirements · Perform all duties with minimal supervision

Routine sample preparation and analysis of water samples by various written EPA and Standard Methods procedures, Performing data process, data entry and written documentation Performing routine instrument maintenance. Preparation of reagents and standards. Other general laboratory related duties as assigned Will include regular late shift and/or weekend duties.

We are looking for a Research Associate to join our Microbiology group to help drive key programs. This exciting role will afford a qualified Research Associate the opportunity to apply their extensive knowledge of microbiology to perform experiments that will aim to cultivate a broad variety of aerobic and anaerobic bacteria, and characterize their molecular, morphological, and physiological features. The successful candidate will possess the required skills in microbial physiology, maintenance and preservation, microscopy, molecular methods, formulation of media composition, and the ability to multi-task within scope.

The Laboratory Service Engineer I (LSE I) is responsible for the service and support of laboratory equipment and instrumentation, including installation, calibration, maintenance, and repair. This includes both simple (e.g., orbital shakers) and complex (e.g., liquid handling robotics.) instrumentation in the various laboratory environments.

The R&D Laboratory Technician II will provide world class service and support for common R&D laboratory functions. The position is expected to follow detailed instructions and established procedures with minimal supervision. Duties include lab organization, equipment maintenance, cold storage sample management and miscellaneous tasks to help the labs run efficiently.

A current and valid California State Clinical Laboratory Scientist License (CLS) or Clinical Chemistry Scientist (CCS). The Clinical Laboratory Scientist is responsible for high complexity testing and analysis to obtain data for use in diagnosis and recording laboratory test results.

The Clinical Supplies Manager will oversee all aspects of clinical supply management including packaging, labeling, monitor inventory levels, and distribution by interacting with internal and external supply partners/vendors to ensure supply of IMP are sufficient at depots and clinical sites.

This introductory-level position is suited for an individual who: i) is comfortable working in a laboratory setting, and ii) thrives in a team-oriented environment. Responsible for performing in vitro experiments as a member of an interdisciplinary team focused on developing and advancing Spherical Nucleic Acid drug delivery platforms.

This position is responsible for preparing conjugated proteins, antibodies, enzymes, oligonucleotides, and microparticles for both manufacturing and research purposes. In addition, this position will be responsible for the preparation and testing of other chemistry related reagents for company personnel.

Perform routine quality control testing of protein, peptide or antibody products using standard operating procedures to determine lot status, product release and product stability. Tests include: concentration determination, SDS-PAGE with densitometry, SEC/HPLC, endotoxin assay, and other testing as assigned. Participation in the validation of new and existing laboratory methods is also expected. The position requires routine documentation, analysis and communication of results within the department and across different groups. Other duties include instrument calibration and maintenance, record keeping, and lab support. Within this job function, the Research Associate must also pursue annual goals that aim to facilitate innovation, efficiency, productivity and team building across the QC Department or the entire company. Perform additional duties as assigned.

This position will serve as key member of the ACD Professional Assay Services (PAS) department, performing RNAscope assay services for industrial, pharmaceutical, and academic clients. The position will have an opportunity to work closely with scientists and investigators from a broad customer base. The Research Associate must be willing to learn new techniques quickly and be able to adapt to shifting priorities in a fast-paced and growing start-up environment. This position will be based in Newark, California.

In this role, you will be using your scientific expertise to directly contribute to Exscientia's mission: making better drugs, faster - by further improving the predictive and generative modeling capabilities of their AI technology platform. They are applying state-of-the-art AI methods to address a diverse range of important problems in drug discovery and are constantly innovating if required tools are not sufficient or do not exist. Their ambition is to draw knowledge and inspiration from additional scientific disciplines such as mathematics, physics or computer science. 

The Application Engineer provides technical support related to the sale of the company’s engineered products based on the industrial process and application details. The Application Engineer will become a process and application expert where Pulsafeeder equipment is used and identify potential growth opportunities. This individual will respond to technical inquiries from customers, both domestically and internationally, company sales reps, and distributors, in a timely manner, and assist in the order attainment process. The Application Engineer will manage sales inquiries through preliminary engineering, costing, pricing, quoting, and follow up to key proposals. This position is also responsible for assisting Order Entry personnel in problem resolution; review of drawing submittals, and in solving technical issues. Key business measures such as quotation and order activity of assigned rep and distributor offices will be monitored with appropriate follow up, assistance, and guidance to assist in obtaining orders. The Application Engineer will work with Sales and the Senior Leadership Team to help to create and track large opportunities in the sales funnel and will participate on forecast calls to share feedback and opportunities for growth.

The ideal candidate shows good judgement and instinct in decision making with a drive for continual improvement of business operations and trade compliance awareness. This is an exciting position that will be leading global strategy, development and implementation of process improvements, and ongoing Group and Business Unit compliance program efforts supporting Fitzpatrick's rapidly growing and evolving businesses.

The purpose of the Web-App Architect/Engineer role is to design and deliver a high-quality, secure, and tightly integrated user experience as part of a high-performance solutions development team.  The primary responsibilities will be to create a globally deployable user experience within IDEX Fire & Safety’s Captium data platform. To succeed in this role, you will have a passion for scalable, Agile software development, foster a culture of collaboration and innovation, and deploy highly reliable and intuitive data solutions that create value for our customers.

As a Janos Process Engineer on our team, you will learn firsthand how infrared optics and assemblies are manufactured and tested. Our products end up in equipment around the world supporting the US military and in commercial night vision products.

This position reports to the Manager of Research Manufacturing and is responsible for the production of recombinant adeno-associated virus (rAAV) vectors via maintenance of mammalian and insect cell lines, transfection, infection, and downstream purification of rAAV by chromatography and ultracentrifugation. You will utilize shake flasks and bioreactors for scale up experiments. You will also be directly involved in scalable downstream purification technologies for rAAV using FPLC systems, tangential flow filtration, and centrifugation. Work activities will also include compiling experimental data and contributing to protocols and study reports with supervision. It is expected that you will work as a member of the production team while accomplishing the timely completion of assignments and reporting of unexpected technical issues.

The Molecular Technologist I performs procedures in a complex patient sample testing process with limited supervision. Most prominently, the position is responsible for solution and reagent preparation, equipment maintenance, and the handling and testing of patient specimens. The incumbent works one of three established shifts and may be assigned to work any day that the lab is operational.

The Molecular Technologist I performs procedures in a complex patient sample testing process with limited supervision. Most prominently, the position is responsible for solution and reagent preparation, equipment maintenance, and the handling and testing of patient specimens. The incumbent works one of three established shifts and may be assigned to work any day that the lab is operational.

The Molecular Technologist I performs procedures in a complex patient sample testing process with limited supervision. Most prominently, the position is responsible for solution and reagent preparation, equipment maintenance, and the handling and testing of patient specimens. The incumbent works one of three established shifts and may be assigned to work any day that the lab is operational.

Freenome’s Clinical Laboratory Associate will support the company’s Pre-Analytical Laboratory with the receiving, accessioning, plasma sample processing, and storage. Important to our mission is providing quality samples to process downstream for quality analysis and results.

The Research Associate, Formulations, is a laboratory-based position with tremendous learning potential in the area of drug formulation development.  Reporting to the Associate Director, Process Development, and working in a cross-functional team environment, the successful candidate will take part in contributing to the development of the company’s PCA technology platform and executing the company’s small-molecule combination strategy. This position will be pivotal in the successful development of pharmaceutical products based on the company’s PCA platform.

The Scientist, Analytical Development conducts all aspects of Analytical Development including method development, experimentation, and record keeping, including developing and implementing methods that meet project needs.

Works with Supervision and Investigative Writers to efficiently and thoroughly investigate deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the quality related deficiencies identified during the investigation process. Responsible to recommend proactive corrections, corrective actions and preventative actions based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of product discards, field actions, or recalls. The position requires working with moderate supervision to manage assigned investigations from initiation to completion.

This individual holding the position of QC Technician II shall be responsible for performing routine testing of in-process and finished product samples, raw material, stability, and utilities.  They shall be responsible for monitoring the environmental conditions in the laboratory and in manufacturing areas.  They shall support validation projects.  This position must be available to work overtime as assigned.

The incumbent is responsible for routine calibration and preventative maintenance in the Quality Control laboratories. Reports to QA Metrology Manager. Duties are of routine nature and are followed according to established standard operating procedures. Problem recognition ability is needed. Non-critical functions utilize independent action and decision making with follow-up reporting to supervision. Supervisor directly responsible for training, assignment of duties and review/approval of work. Direction, training and some day-to-day supervision may also come from a Scientist or Lead Scientist. Effectively communicates work and results both orally and in writing.

This position serves in the capacity of performing general laboratory tasks of testing finished products, stability, raw material, utilities, and monitoring for environmental control, as well as supporting validations of rooms, equipment and materials. This position reports to the supervisor for the functional area to which they are assigned and has no direct reports. The QC Technician II position works closely with other departments, such as validations, chemistry, Operations, Product Development, Quality Systems and Product Release to assure the support of the Microbiology department on various projects, studies and routine tasks.

Responsibilities: Perform clinical trial study protocol analysis, generate quote, prepare and review proposals/contracts, and keep track of the status of potential incoming projects. Working closely with the clinical operation team and develop the Cost Per Test Table. Participate and communicate effectively in the client and internal meetings. Generation of clinical trial related documentation as needed and per client request. Support Management and BD team for new business opportunities and assist with all functions of Clinical Trials Proposal and Budget generation, providing support for all Clinical Trials Business Development staff. Assist to ensure all areas of proposal and budget development, including development and maintenance of Standard Operating Procedures. Maintain a general working knowledge of phase I-IV clinical trials and basic laboratory terminology.

Responsibilities: Provide support to Study Directors and Program Managers for the purpose of facilitating study operations, report production and program oversight. Address problems, conflicts, or difficulties that pertain to assigned studies and negotiate and/or implement solutions. Detail oriented delegated duties. Data entry of pertinent quality control and data set information. Review and organize research data sets for the purpose of Quality Control. Create control documents, test procedures, SOPs, etc. as needed. Draft study documents including forms, protocols, amendments, reports, etc.  Edit, compile, and/or format documents. Assist with report finalization by collecting signatures, document management, CD/flash drive preparation, and archiving.

Responsibilities: Validation and verification studies of new instrumentation and methods. Establish and maintain standard operating procedures for designated methods. Perform maintenance and quality control for all instrumentation and methods. Troubleshoot and repair instrumentation, liaise with service engineers and instrument vendors. Adhere to safety and quality procedures, participate in Proficiency Testing, maintain competency on all instrumentation (six month and annual). Sample analysis including Chemistry, Hematology, Urinalysis, Coagulation, Molecular, and COVID-19 testing.

The individual will assist with the analytical study design, performs testing and analyses to support new product launches which includes design verification, other designated analytical protocols, and summary reports adhering to appropriate regulatory guidance, specifically CLSI.

We are seeking a highly motivated, do it all research associate to join our efforts in the Discovery Biology group at Fulcrum to participate in building our next generation Muscle Biology platform. This individual will contribute across programs to scientific efforts focused on interrogating disease biology focused on understanding cell state dysregulation inherent to the dystrophic microenvironment.

This Program Manager will be accountable for proactively identifying and assessing compliance risks. They will create a portfolio of projects and work closely with the Director of Clinical Operations Excellence to manage through to completion. They will also proactively monitor emerging regulations and policies and ensure GBT proactively monitors and mitigates risks. 

Under direct supervicion, this position is responsible for assisting manufactuing and team members in carrying out process development, technology transfer, quality control, manufacturing processes and tasks involving a variety of laboratory methods, equipment, and procedures.

The Biopharma Enterprise Solution Developer for the Biologics business unit supports the installation life cycle of the Genedata Biopharma Platform at customer sites in the US and in the cloud. The primary role is the development of configurations and external solutions to assist with the roll-out of our core product at customer sites. This position is also responsible for installing, maintaining, and updating the Genedata Biopharma Platform and contributing to technical, quality, and process documentation.

GeneDx is a rapidly growing CAP and CLIA certified diagnostic genetic testing laboratory for molecular genetics. Our historic mission has been to make clinical diagnostic testing available for people with genetic conditions and their families. We apply cutting edge technologies that provide a wide array of molecular genetic diagnostic tests, including whole exome sequencing and next-generation sequencing panels. We specialize in genetic testing for rare hereditary disorders, but also test for common disorders. To learn more about GeneDx, please visit our website at www.genedx.com.

GeneDx is a rapidly growing CAP and CLIA certified diagnostic genetic testing laboratory for molecular genetics. Our historic mission has been to make clinical diagnostic testing available for people with genetic conditions and their families. We apply cutting edge technologies that provide a wide array of molecular genetic diagnostic tests, including whole exome sequencing and next-generation sequencing panels. We specialize in genetic testing for rare hereditary disorders, but also test for common disorders. To learn more about GeneDx, please visit our website at www.genedx.com.

We are seeking a Bioinformatics Engineer to join our team supporting clinical next-generation sequencing tests within GeneDx. In this role you will join our software operations team, working closely with our laboratory and scientific staff, and fellow developers on the Data Science team to assess, investigate, and resolve data-related questions and other issues that arise during our production clinical testing. You will also monitor our production pipelines, tracking system stability, implementing code improvements, and assisting with both software and qualitative validations. You will learn and follow internal guidelines for good software management and release practices, as well as taking time for team-based code review, optimization, and continued learning.

He/she will help evaluate protein expression constructs and expression levels for a wide variety of proteins of therapeutic interest in support of basic research, small and large molecule drug discovery. He/she will support automation-driven protein construct screening in a core facility setting to enable large-scale protein production and work with stakeholders to optimize expression levels and quality of proteins. The successful candidate will be responsible for performing protein expression, small scale purification and characterization of proteins (affinity purification, SDS-PAGE, Western analysis) produced using E. coli, baculovirus, and mammalian transient systems.

The Manufacturing Technician will be responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.  Performs media/buffer solution preparation operations.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

As a Bioprocess Manufacturing Technician, you will be responsible for producing medicine in a highly automated and controlled environment.  Each product has a specific recipe; you will follow this recipe, along with the standard operating procedures, to operate the production equipment across various areas, including raw material dispensing/aliquoting, cell culture and purification.  You will maintain records and follow all the steps necessary to comply with regulatory requirements within a current Good Manufacturing Practices (cGMP) environment.   

Within the Purification department this team member will develop, characterize, validate and implement recombinant protein and novel therapeutic purification processes from laboratory to manufacturing scale. This individual will interact with engineers and scientists within the Pharma Technical Development organization as well as collaborate with members from Manufacturing, Quality, and Regulatory.   

Under supervision from senior contributors, serve as a mechanical engineer for concept-to-market and sustaining engineering efforts of IVD instrumentation. Apply hands-on involvement in on-market support for existing and new products, troubleshooting and root cause analysis, creation and maintenance of input and output specifications, concept and feasibility activities, prototyping, testing, and transfer to manufacturing.

You will execute a range of molecular biology procedures, reagent preparation, data analysis, and laboratory duties under minimal supervision. You will work closely with cross functional teams to investigate root cause of anomalies reported during Quality Control or from Customer Technical Support.  

This new exciting role at GenMark will work under supervision from senior contributors, serve as an electrical engineer in sustaining engineering and concept-to-market efforts for IVD instrumentation. Apply hands-on involvement in on-market support for existing and new products, troubleshooting and root cause analysis, creation and maintenance of input and output specifications, concept and feasibility activities, prototyping, testing, and transfer to manufacturing.

This position will be responsible for executing lab and pilot-scale experiments that contribute to the development of novel processes for the production of chemicals via fermentation. Technical areas of responsibility span fermentation and downstream separation steps such as filtration, centrifugation, chromatography, extraction, and distillation. He/she will assist in experimental planning, independently set-up, operate, clean and maintain equipment at the bench and pilot scale; collect experimental samples, perform sample assays, perform data analysis and reporting, and maintain/order lab supplies.

This position plays an integral role in Genomatica's strain and fermentation process development, working together with other multi-disciplinary scientists and engineers to optimize microbial hosts in diverse bio-based processes. The successful candidate will have demonstrated capabilities of conceiving innovative experimental design and executing small scale well-plate based experiments with moderate supervision. Having abilities of scientific creativity and critical thinking is crucial to develop innovative solutions in a team environment.

This role works on fermentations of microbial strains engineered for production of industrial chemicals.  The bulk of this work is carried out in bench-scale bioreactors.  This position will interface closely with the Fermentation engineers and scientists in the Fermentation Science Group to produce conclusive fermentation results that will guide process optimization and scale-up efforts.  

Responsibilities: Lead a project to develop plasmid prep production process and to optimize the procedure and maximize the work efficiency. Work with automation engineers and vendors developing automated plasmid prep automation line. Work with QA group to optimize the consistency of production from batch to batch. Lead other laboratory procedure improvement projects. Ensure compliance with the correct procedures, policies, and health and safety regulations.

GigaGen is looking for a research associate to support the expression of antibodies and antibody derivatives for early in vitro testing, in vivo efficacy studies, and tech transfer runs for development. This will include both routine protein purification and polishing tasks, as well as frequent process development for novel proteins. This position will span both research and development work, with ample opportunity to learn new methods, design your own experiments, and present your work.

Responsibilities: Operate and improve processes for strain analysis. Equipment troubleshooting and maintenance. Apply DOE approaches to refine and improve sample extraction and assay methods. Develop processes for verification and quality control of assays to ensure low CV and high reproducibility. Use Ginkgo's Software and Automation infrastructure to execute assays and strain tests. Collaborate with software engineers to ensure that all generated data is captured, stored, and analyzed in Ginkgo's LIMS.

Responsibilities: Prepare components and build assemblies. Prepare bulk drug formulations. Perform filing, capping, and crimping operations. Perform packaging and labeling operations. Perform sampling and visual inspections. Perform documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR). Perform and/or track clean room, environmental chambers, and equipment preventive maintenance (PMs).

As a QA Coordinator, you will provide support to the site when implementing new products, review of records to ensure compliance with local and regulatory guidelines, and to execute Quality Systems actions. This role may develop, implement, and administer input and in-process electronic quality systems for the production of biopharmaceutical products to ensure compliance with GSK internal procedures, policies, standards, and worldwide regulatory expectations. This role will act as advisor, facilitator, and team member regarding regulatory compliance and quality systems for all aspects of manufacturing of biopharmaceutical products. This is accomplished through direct intervention between this role and other staff in the facility. This role provides quality decisions to project teams and to routine operating teams. This position will provide guidance and training to new and existing employees in the Quality Assurance department and assist them with decision making.

Are you looking for a new challenge to drive and improve quality control testing, with a chance to broaden your leadership skills? If so, this Associate QC Chemist role could be a great opportunity to consider. The Associate QC Chemist is responsible for performing quality sampling, testing and data review for raw materials under cGMP conditions. The role will support the manufacturing campaigns by ensuring raw materials testing completion within established timelines. The role will also support operation and maintenance of QC laboratory equipment/instrument to comply with cGMP regulations.

Individuals with an interest in biopharmaceutical drug discovery to learn and conduct laboratory techniques as a laboratory research associate. This position is an entry-level role at Gliknik.

The Biology Department at Global Blood Therapeutics is looking for a qualified Research Associate with experience in assay development and biomarkers. This position will be primarily responsible for biochemical and cell-based assays to support animal studies across multiple pipeline programs. The applicant will also provide logistics and troubleshooting support for animal and clinical studies conducted externally. An ideal candidate will be detail-oriented, organized, and comfortable working both independently and within a team.

The Research Engineer will be responsible for planning, coordination, successful execution, and publication of various research projects for spine surgeons, residents, and product development. In addition, this position will function in a cross-disciplinary environment and must have experience or be willing to be trained in image analysis, micro-CT, biomechanical principles, and orthopedic basic sciences.  The Research Engineer must have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion.

The Lovett Quality Control lab team is looking for an energetic, flexible, organized, and high performing QC lab associate in Elkton, Maryland. This associate will have primary responsibility of routine testing for product release and process monitoring in the QC lab as well as support projects that partner with new product development and engineering associates to develop and optimize new test methods. 

The Associate / Sr. Associate Quality Assurance will support the company’s quality and regulatory systems in compliance with industry best practices.  The Associate will implement and maintain corporate and departmental procedures. This position will additionally serve as an integral member representing quality on cross functional teams.

GRAIL is seeking a Laboratory Technician 1/2 for the R&D Laboratory Management team, who will be primarily responsible for ensuring the efficient operation of GRAIL Research and Development activities. The ideal candidate is a detail-oriented, dynamic team player with experience in both automated and manual molecular biology workflows combined with strong interest in NGS methodologies.

The Clinical Laboratory Associate (CLA) - Accessioning on the swing shift will assist in building and establishing GRAIL’s Clinical Laboratory, performing specimen testing and supporting the daily operations of the Clinical Laboratory. The focus of the CLA - Accessioning will be on the receipt, triage, accession, and centrifugation of patient samples submitted to the CLIA laboratory for testing.

Supports quality control and assurance by assisting the microbiology department with environmental monitoring, water testing, and client specific testing.

Job Summary: Assist the Engineering and Operations departments by specializing in facility and utility optimization and providing subject matter expertise (SME) on mechanical systems. Provide logistics lead projects. Oversee construction activities demonstrating, building, and enforcing the best practices for all engineering projects and functions within the facility. Work independently on multiple high-profile tasks simultaneously to ensure maximum uptime of the facility. Work closely with maintenance staff to help coordinate inspections and repairs, as well as the testing and calibration of all instrumentation, electrical, and mechanical systems. Aid the Engineering Manager in day-to-day facilities administration.

Job Summary: Support the quality systems as they relate to the manufacturing and testing of cGMP drug products, including the review of documentation and quality records associated with filling, terminal sterilization, visual inspection, labeling and packaging.

Responsible for performing various routine manufacturing tasks following established procedures and cGMP regulations under guidance of a production supervisor and/or senior management.

GreenLight Biosciences is seeking exceptional, highly motivated Research Associate to work on the development of cutting-edge fermentations and/or cell free bioprocessing technology. The successful candidate will work hands-on in small teams to execute fermentation/cell free bioprocessing and other associated bioprocess unit operations (such as homogenization, pasteurization, centrifugation, ultra-filtration/defiltration, microfiltration, depth filtration, focusing on recovery of large molecules). A high degree of flexibility, creativity and initiative is essential for success. Strong technical, organization, communication, inter-personal, and trouble shooting skills are essential. The RA will comply with company policies and practices for EHS and will support company and organizational targets and functional growth plans.

The GreenLight team is looking for a high-performing, self-motivated individual who works well in a fast-paced environment in a leading-edge biotech company. The company is looking for a key individual to play a pivotal role in advancing breakthrough therapies to rapidly address emerging pathogens. Reporting directly to the QC Laboratory Sr. Manager, the individual will be a key contributing member of our Life Science Team. The position will assist in establishing and running a Quality Control (QC) Laboratory providing support to the advancement of mRNA based human vaccines and other RNA based therapeutics. The ideal candidate will have the skills and experience necessary to build and equip a QC laboratory capable of supporting development, pre-clinical, clinical, and eventual post-marketing approval analytical testing.

The successful candidate will work closely with a diverse R&D team to achieve company goals and help advance the company’s RNA platform technology.

This is an Entry Level position, ideal for recent graduates and early career stage researchers looking to work in a start-up environment. The candidate will work collaboratively with internal and external teams to help advance the Human Health discovery and clinical pipeline. Research activities will involve all stages of the vaccine discovery pathway from antigen discovery, characterization, and evaluation in vitro and in vivo to the validation of clinical samples from human trials. Applicants should be outstanding at lab-based research, collaborative team members, excellent communicators with a passion for learning, innovation and improving human health. 

This role supports the research function by assisting with basic research projects such as glassware and reagent needs of Grifols Diagnostics R&D lab functions by processing glassware and other technical materials in a GLP-compliant method. The research projects could be in molecular biology, immunology, microbiology or biochemistry. This is an entry level position for someone with limited experience. Prepares and weighs samples for testing and analysis. May setup and conduct tests, assays, and other protocols under the direction of an R&D scientist. Follow Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLPs). Ensure all laboratory equipment and work areas are clean, sterile, and in proper working order. Responsible for calibration of instruments where needed, as well as ordering and restocking lab supplies/chemicals.

The QC Chemist is responsible for performing routine and non-routine chemical and biochemical assays on protein-based therapeutics and raw materials. Responsibilities: Perform various QC / Quality Control testing (i.e. product release testing, stability testing, in-process testing, and other protocol testing) as directed by the laboratory supervisor or senior chemist. Compile and enter data into computer database (i.e. LIMS - Laboratory Information Management System) to be used for reporting and trending purposes. Review test results against specifications.

This manufacturing associate position is responsible for the production of recombinant antigens, peptides and or buffers. Specific responsibilities: Provides necessary support for all production activities associated with the Antigen production work. Operates complex antigen production equipment. Participates in equipment and process qualification and troubleshooting. Maintains the production areas and all equipment in clean and orderly operating condition in accordance with cGMP, ISO and Grifols quality and safety standards.

The Automation Engineer I is an entry level professional who is responsible for using technology to improve and streamline a manufacturing process through automation. Depending on their specific assignment, this person provides automation support for projects or within a specific area or provide validation support for automation projects.  The Automation Engineer I can also integrate into a project team.  The incumbent is knowledgeable in Automation with the capability to learn specific control systems, instrumentation, process, utilities, or qualification testing.  He/she supports meeting customer needs and business goals. In addition, he/she will collaborate with other automation engineers.  

The QC Analyst will be asked to provide expertise to their designated QC group for the purpose of supporting both manufacturing and quality assurance in the production, release, and monitoring of established product lines.

The candidate for this position will be instrumental in developing GRO’s new biofoundry. You will work in partnership with skilled scientists and engineers to accelerate their research through a variety of automation platforms. Your creativity and ingenuity will be crucial for all of GRO’s research priorities, including developing new products, optimizing strain performance, and evolving novel amino acid platforms.

Responsibilities: Manage quality support for operations including device history record and batch release processes. Drive measurable quality improvements in support of operations. Manages quality, compliance, and timely closure of complaints through manufacturing investigations. Supervises Quality Engineers and Specialists that process complaints about the site. Oversees, coordinates, and participates in elements of investigations regarding customer complaints.

Responsible for inventory management of reagents and consumables, sample receipt and tracking, and various laboratory support tasks including, but not limited to, reagent preparation, housekeeping duties, and equipment maintenance. The Lab Coordinator must be self-motivated, organized, and flexible and able to work under deadlines in a fast-paced environment.

We are looking for a highly motivated Research Assoc./Sr. Research Assoc./Scientist to join our Translational Medicine group to execute preclinical studies and provide in vivo proof-of-biology data on Harpoon’s drug candidates, demonstrate in vivo mechanisms of action, as well as scientific rationale to support combination clinical trials. This position is laboratory based with the successful candidate collaborating across groups to plan, execute and analyze in vivo studies.

Responsibilities include testing of samples in support of both preclinical development and clinical programs, assay development and optimization, and collection of data in support of regulatory filings. Applicants should be capable of working flexibly and expeditiously in a collaborative, innovative and inspiring environment. The ideal candidate will have experience with mammalian cell culture, stable cell line generation, luciferase assays, flow cytometry, and bioassay automation. Good communication skills, good planning, and an ability to meet deadlines are essential.

The qualified candidate will work within a multi-disciplinary team of engineers on DFM, cost reduction, and transfer to production activities. Work closely with assemblers and production leaders to improve manufacturability. Investigate quality issues for engineering improvements.

The CRA will be responsible for performing on-site monitoring visits for various client studies to ensure patient safety, GCP compliance and data integrity by confirming the site is conducting the study in accordance with the protocol, ICH guidelines, and applicable regulatory requirements.

We are seeking an energetic and self-motivated formulation technician to drive forward product development. Specific emphasis will be given to those applicants interested in a challenging opportunity with immense impact and who flourish in a fast-paced environment. The formulation technician will manage the production inventory, produce/fill/seal builds of reagents into HelixBind’s proprietary disposable test cassette, will actively communicate with management and co-workers and will maintain a safe, organized, and clean work environment.

The Engineering Technician will work to maintain, troubleshoot and repair medical diagnostic instruments, commission new equipment, through quality service and professionalism. We are seeking hard working, motivated, and well-organized individuals with a focus on continuous product improvement to exceed expectations.

The formulation technician will manage the production inventory, produce/fill/seal builds of reagents into HelixBind’s proprietary disposable test cassette, will actively communicate with management and co-workers and will maintain a safe, organized, and clean work environment.

This position will contribute to tissue culture related activities involved with delivering high quality cells for use in assay development, High Throughput Screening, High Content cell-based assays, compound profiling, technology evaluations, and other objectives requiring delivery and maintenance of live cell cultures and/or frozen cell banks.  These activities will be in addition to the other standard aspects of clinical lab testing.

Responsibilities: Facilitates the investigation and response to customer complaints and internal issues. Determine and eliminates root causes and diminish defect occurrences or quality incidents in the process. Supports the Quality Manager with internal and external audits, customer surveys, and respond or resolve corrective and/or preventive actions and verifications. Develops new approaches to solve problems identified during quality assurance activities. Supports the Quality Assurance group in streamlining Quality documentation.

The incumbent will assist the R & D Manger in the successful development and completion of experiments and studies aimed at supporting USDA licensure of veterinary biological products. Plan and execute scientific studies leading to the development and introduction of products, process and product control, and improved methods specific to the optimization of animal vaccine production. May develop in-process assay methodologies as needed and will assist in the validation of new final product assays.

We have an opportunity for an exceptional cell biologist to join our growing drug discovery team. At Hexagon, you will be an integral part of a dynamic interdisciplinary team focused on developing next generation medicines. You will use your strength as an experimentalist to assist in designing, developing and optimizing target specific cell assays. You will work with senior scientists to plan, execute, and analyze your experiments and present your results.

At Hexagon, you will be an integral part of a dynamic interdisciplinary team focused on developing next generation medicines. You will use your strength as an experimentalist to assist in designing, developing and optimizing target specific cell assays. You will work with senior scientists to plan, execute, and analyze your experiments and present your results.

This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment, raw materials, and manufacturing processes.  Validation activities include research, protocol writing/execution and final report generation.  Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented.  Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.

The individual is responsible for performing functions within the Microbiology Laboratory related to Environmental Monitoring of controlled production areas. The duties also include equipment maintenance and LIMS management.

The scientist schould expect to perform routine, work-flow processes within the quality control laboratory to meet customer requirements by supporting the testing of raw materials and finished products while ensuring regulatory compliance standards and release times are met.

Responsibilities: Develop clinical plans for respiratory health to build clinical evidence for key clinical value propositions addressing short term as well as longer term needs through various forms of research including review articles, health outcomes research, post-marketing studies, and clinical trials to support regulatory submissions (PMA, IDE, 510(k)). Serve as the clinical expert with primary focus on the product lines interacting with marketing, regulatory, and research & development to ensure clinical activities are aligned with business objectives.

The Product Quality Engineer is responsible for supporting the quality and regulatory related matters associated with the medical bed devices at the Hill-Rom Batesville Manufacturing site.  This position will also be responsible overseeing and/or assisting with a variety of Quality Engineering functions and ensuring compliance with QSR regulations and Hill-Rom policies and procedures.  In addition, this position will work to provide the necessary data to make effective quality and business decisions, and implement sound, data-driven quality and business solutions that emphasize quality system compliance.

Homology Medicines seeks an outstanding researcher in the upstream process development group to assist in the development of viral manufacturing processes. The individual in this role will be highly motivated, enthusiastic and brings rigor and a desire to deliver on tasks with focus on the development and scale up of cell-based methods for producing AAV vectors. We seek candidates with proven ability to work independently after initial training and collaboratively to achieve optimized project plans, with the goal to deliver products that transform the lives of patients.

The Clinical Project Coordinator (CPC) will be responsible for assisting the study team in running the day to day operational activities of clinical studies.  The individual will be responsible for the coordination, tracking and management of daily activities for multiple clinical studies to support both the internal team and Clinical Research Organizations (CROs).

The job of the product specialist is to provide complete technical support to the customer base in order to resolve customer issues and problems. The product specialist will answer customer phone calls and emails to ensure problems are resolved. The product specialist will also install HORIBA products at customer sites. The objectives are to complete assigned tasks in an efficient and timely manner and comply with companies' guidelines: includes customer support, product installations at customer site, product testing as well as QA/QC, service training and technical notes writing.

Responsibilities: Assisting senior engineers/consultants with various engineering tasks required to support customers� implementation of ISO 26262 for functional safety. Utilizing your existing and new skills to manage challenging stakeholders who can have diverse objectives with pressure to deliver results. Working closely with the existing company electrical/electronic development teams (systems, hardware, embedded software, integration). Coordinating with supplier management teams. Assisting in deliver to time, cost and quality in regard to the functional safety process.

The Engineer I, Quality � Service and Repair works in a Quality Systems environment to ensure that the servicing of infusion pumps meet the requirements of ISO 13485-2016, 21 CFR Part 820, and other applicable regulations and standards. They support key areas to maintain an effective Quality System such as: quality operations, complaint investigations, CAPA investigation, risk management, internal audit, service data collection, analysis and trending. The incumbent encompasses a professional that can work within a quality management system and under the guidance of the immediate supervisor/manager to develop the skills, experience and competences to work in a regulated environment and very dynamic role. They complete projects assigned by experienced engineers and managers. Works on projects/matters of limited complexity in a support role while being closely managed.

The Mechanical Engineer 1 will play a key role in manufacturing sustainment and new product introduction of world-class DNA sequencing instruments. Under the supervision of senior engineers, you will design and build test fixtures, perform qualification testing of critical mechanical components and sub-assemblies, and contribute to continuous improvement projects, while interfacing with other functional teams in Hayward, Foster City, San Diego, and Singapore. Not to mention, collaborate with external suppliers and contract manufacturers who build our submodules.

As a Research Associate 1 at Illumina, you will work in a dynamic, collaborative environment and help the reagents/assay team in the development of core platform consumables to create cutting edge and robust new products. You will participate in the development of both analytical and high-throughput assays and processes. You will work in a fast-paced environment with multi-disciplinary teams, design and execute experiments, analyze data and communicate results and progress. Your work on reagent formulation, characterization, stability optimization, workflow development, and various assays and will enable project teams to make critical decisions during a product development cycle.

This is a hands-on, independent position where the incumbent is responsible for the design and execution of experiments for product/process optimization, development/optimization of analytical methods, and qualification and/or validation activities ensuring the successful technology transfer into a GMP manufacturing environment.

As an Integration Research Associate 2 in Illumina�s Systems Integration group, you will work as part of a multi-disciplinary team to develop and integrate assay workflows for Dx platform verification and validation.

The Internal Clinical Research Associate I (ICRA I) will provide support to the various clinical departments within IMARC. Responsibilities: Obtain a familiarity with and understanding of clinical trial documentation format, content requirements, and operational procedures. Update internal databases to ensure sponsor and study-specific timelines are met. Support clinical staff in all departments. Perform document review for quality control of study documents, including maintenance of internal files, report corrections, document filing and processing. This includes peer-reviewing confirmation letters, formatting training presentations, and assisting with other review as requested.

We are seeking a talented and collaborative molecular biologist to perform and develop large scale screening studies, technology optimization and confirmatory assays. The successful candidate will work closely with team members and support discovery and pre-development programs.

The Regulatory Affairs Specialist is primarily responsible for preparing IVD regulatory documents for submission to various regulatory agencies, both domestic and international 

In collaboration with the current quality team members, the successful candidate would be trained to support quality control and quality assurance functions.  These functions may include technical report review at project completion and internal auditing against both ISO 9001 and/or 17025 quality standards, as well as GLP/cGMP regulations. 

Our Discovery Chemistry group is looking for an experienced Chemist. The Research Scientist develops and optimizes chemical reactions for the synthesis of novel compounds to support SAR.

the candidate will be responsible for performing in vitro and in vivo studies for cancer immunotherapy drug discovery programs.

The role of Molecular Technologist is to perform DNA processing and sequencing analysis and review results from high-complexity molecular testing of human (patient) specimens under CLIA/CAP and other regulatory guidelines. They perform patient testing utilizing the molecular workflows associated with the relevant clinical diagnostic assays

Assists with preparation of autoimmune diagnostic Immunofluorescence Assay (IFA) cell culture slide products according to established procedures. Major duties include mammalian cell culture, immunofluorescence cell suspension and slide preparation activities. 

Performs major manufacturing duties including assistance with the activities required to produce ELISA calibrators, controls and conjugates.

The RAI works under general and specific direction in performing a spectrum of techniques in both cell culture and immunology. The RAI works collaboratively and independently in the lab, solves problems, completes required documentation, and performs general lab duties.

Inscopix is seeking a Neuroscience Technical Project Manager to lead their product development cycle from managing requirements to leading the validation process and launch. The candidate will collaborate with an interdisciplinary team of neuroscientists, data scientists and engineers from software, mechanical, optical and electrical engineering fields.

As a member of the Applications Development team, the Research Associate/Sr. Research Associate will be an internal customer of Inscripta’s Onyx platform, applying their digital genome engineering capabilities to tackle cutting edge research in E. coli and other microbes. Inscripta is seeking a diverse candidate to work in a collaborative group to apply principles of forward engineering and genome discovery across a variety of microbial strains. The Research Associate/Sr. Research Associate will work closely with internal and external collaborators on cross-functional teams to generate high-quality data across multiple projects.

The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. Ensures Integer internal and external customer expectations are met or exceeded.

Our company is in an exciting growth phase where we are launching new products and reaching new markets. To support our growth, we seek a Research Associate I, who will work with a dedicated group of scientists on the development and commercialization of biomedical technologies.

Integral Molecular is seeking a highly organized BS/MS level scientist to manage projects utilizing their antibody discovery platform (Membrane Protein Solutions).

Integral Molecular is seeking an entry level Laboratory Technician to perform vital laboratory tasks to support the continued success of their research teams. The candidate will be part of a lab management team that works in a unified and collaborative manner to ensure the efficient operation of the laboratory.

Assemble study designs, perform laboratory experiments, organize data, and analyze results under minimal supervision. Handling and maintaining mammalian cell culture and perform biological activity assay by using aseptic technique.

Manufacturing Associate will be responsible for the manufacture of pre-clinical/clinical products Operates the production processes according to the determined daily production planning. Works according GMP regulations.

As an Associate Scientist, you will help support the characterization and quantitation of gene editing events using high throughput next generation sequencing (NGS).

Intellia is seeking a highly skilled and motivated Senior Research Associate for their ex-vivo Cell Therapy group. The primary responsibility for this position is developing and optimizing in vitro immunological assays to evaluate engineered immune cell function for cancer therapy.

The successful candidate will have opportunities to work with principal investigators to manage complex nonclinical activities while gaining broad experience in product development in an industry environment. 

IntelliSyn Pharma is looking for motivated Associate Scientists to help drive our drug discovery programs.

Primary Function of Position: Contribute broadly to the Advanced Product Development team, responsible for advanced analytics and new technology development focused on the performance for next generation robotic surgery platforms.

Responsibilities: Work in a small cross-functional project team to design, develop and verify designs for flexible surgical instruments and accessories. Work with KOLS and develop concepts based on early clinical, marketing, and customer inputs including early prototyping of designs. Lead early stage ideation and prototyping efforts. Evaluations of prototypes, critically analyze results, and make design changes or recommendations with the design team. Provide support for pre-clinical and clinical labs

This individual will focus on developing cutting-edge BLI and LSA workflows to expand and revolutionize Invenra’s current drug discovery pipeline. As part of the Innovation group, the successful applicant will work in a team to improve the efficiency or quality of immune-oncology drug discovery. Details of the job include managing and developing protocols on BLI and LSA instruments, protein binding experiments, high-throughput drug screening, and optimizing project-specific screening funnels. The position requires excellent understanding of protein biochemistry, scientific and problem-solving skills, detailed and well-organized, technological savvy, and the ability to try new things.

Invicro is currently looking for an Associate Scientist who will assist with in vivo, small animal medical imaging studies, including nuclear medicine studies (PET/SPECT), computed tomography (CT), and magnetic resonance imaging (MRI) in the context of a multi-modal imaging laboratory to aid in the development of novel therapeutics.

This position is responsible for compiling and analyzing data for internal and external customers.  The analyst would collect data and perform data analysis for scientific publications, marketing materials, external collaborations, and internal studies. Responsibilities include both simple data pulls as well as complex analyses that require original thinking and novel analysis.  The candidate must be able to collaborate with customers at all levels of clinical and technical expertise, including genomic scientists, genetic counselors, medical geneticists, bioinformaticians, AI engineers, data scientists and computational biologists. In

Due to the expansion of our R&D capabilities, we are currently on the hunt for a Research Associate to support our research in Drug Discovery team.   As a Research Associate, you will work with Scientists and other team members to drug discovery efforts. You will be generating and maintaining mammalian cell lines as well as conducting various cell-based and biochemical assays based on established protocols.   Inzen Therapeutics offers the challenge and opportunity to work at an early stage, big concept biotechnology company. Your efforts will enable our teams to discovery novel targets that could need to the development of a life-changing therapies.

Responsibilities: Synthesize and isolate synthetic oligonucleotides using automated equipment in a cleanroom environment. Operate equipment from laboratory scale to large production scale. Formulate reagent and buffer solutions following standard operating procedures (SOPs) in accordance with current good manufacturing practices (cGMPs). Investigate process improvements and scale-up methods. Perform cleaning of production equipment following established SOPs. Document cGMP production activities by completing all forms, reports and records. Develop Standard Operating Procedures and manufacturing documents for process and equipment operation.

The Clinical Trial Master File (TMF) Manager is responsible for eTMF quality as per GCP/ICH guidelines for all Ionis sponsored clinical trials (domestic and multi-national). This manager position will manage the document control processes and systems for GCP activities in compliance with Ionis internal procedures and policies, review suitability of documentation for filing, maintain the TMF records including storage, retrieval, retention, and destruction per Ionis SOPs. This position serves as the main contact with the project teams and cross functional departments. The manager will plan and perform internal periodic quality checks, provide support to the clinical teams during regulatory inspections for record organization and retrieval, be the subject matter expert for the TMF process, develop and provide training to those requesting access to the TMF, and provide metrics to the team. This position will also manage direct reports.

Ionis is looking for a motivated individual to join their Oligo Synthesis / Medicinal Chemistry group. Candidate will assist with high throughput synthesis of oligonucleotides on 1 – 2 µmol scale. The candidate will also provide synthetic support to the Medicinal Chemistry group including the synthesis and purification of oligonucleotides, oligo precursors, and oligo conjugates.

Iovance Biotherapeutics is seeking an Aseptic Manufacturing Technician to join the Operations team for the new Iovance manufacturing site. Responsibilities: Develop a comprehensive understanding of and be able to proficiently execute Iovance’s current cell therapy manufacturing process. Complete training sessions and ensure training documentation is maintained. Understands and complies with quality standards and requirements as documented. Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance. Supports technical transfer and additional research level testing activities. Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.

The Associate Scientist Core LC/MS (Liquid Chromatography/Mass Spectrometry) employs liquid chromatographic separation techniques and mass spectrometric analysis for data collection. This is an entry level analyst position that will work under the tutelage of higher-level analysts in the Core LCMS lab.  In addition to instrument operation, the Associate Scientist may with some initial supervision perform basic instrument maintenance.  The analyst is responsible for documentation in accordance with SOPs and regulations, and data processing in a manner which meets company quality best practices, objectives and timelines.

Prepares or contributes to the preparation of pharmacokinetic (PK) method validation and bioanalytical sample analysis reports for either internal Q² Solutions customers or external clients under the guidance of senior staff.  May also prepare other technical documents and deliverables.  Participates in project teams and may lead specific tasks, consulting senior staff as necessary.

Acts as a Lead Medical Writer on straightforward projects (e.g. simpler documents under standard timelines). Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Negotiates timelines and discusses/resolves customer comments, with senior support as needed. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including GCP, along with developments and advances in drug development/medical and/or technical writing.

Responsibilities: Perform multi-step drug substance synthesis and API crystallization in the range from milligrams to kilograms under cGMP and FDA compliance. Conduct compound impurities and chemical structure elucidation for chemical intermedia and drug substance utilizing techniques of FTIR, 1 H-NMR, LC/MS, UV-Vis, HPLC, and GC. Execute pharmaceutical unit operations simulation/modeling to support characterization and process challenges in development of API. Conduct pharmaceutical kinetic study to facilitate scale-up of controlled crystallization process in CSTR (Continuous Stirred Tank Reactor).

The Associate Scientist will be part of a team of scientists utilizing a broad spectrum of biophysical techniques to characterize physical attributes of therapeutic assets developed by JBIO, from initial hit generation through lead molecule selection, concluding in the delineation of the biophysical and structural quality of clinical candidates entering the development portfolio. The Associate Scientist is a laboratory-based position that will contribute to the Biophysics team by conducting binding affinity and kinetic assays, such as Surface Plasmon Resonance (SPR) and Biolayer Interferometry (BLI). The Associate Scientist might conduct additional characterizations to assess protein purity and stability using chromatography, light scattering, spectrometric and calorimetric techniques. The associate Scientist will collect, interpret, and report a range of biophysical data and present to manager and project teams in order support lead molecule selection. The associate Scientist is expected to be self-driven, organized, and have excellent analytical and interpersonal skills.

The Discovery Chemistry group is committed to the delivery of high-quality drug candidates working with all six Janssen Therapeutic Areas (TA) discovery teams. This mission requires deep scientific expertise in a number of disciplines including chemistry, cellular and molecular pharmacology, enzymology, and screening technologies coupled with an ability to work collaboratively with internal and external partners. Building on a strong legacy of success, we are currently seeking an outstanding individual to join our team as Associate Scientist, Discovery Chemistry. We are seeking an experienced Bachelor’s- or Master’s-level medicinal chemist with excellent organic synthesis expertise to advance small molecule drug discovery programs toward the clinic. In this laboratory-based position, the successful candidate will partner with both internal and external medicinal chemistry teams to generate innovative solutions to synthetic and medicinal chemistry challenges within the context of small molecule drug discovery projects. She/he will maintain close interactions with computer assisted design scientists and biologists. Strong people skills and the ability to thrive in a team and goal driven environment are key attributes. This individual must also excel in communication and have strong interpersonal skills necessary to influence in a collaborative multidisciplinary environment.

Jnana Therapeutics is seeking an enthusiastic and highly motivated Research Associate to support internal SLC drug discovery programs. Through small molecule screening and a range of cell-based assays, their research aims to expand their understanding of SLC transporter biology and ultimately discover drugs modulating these proteins. Prior experience is preferred but not required. Strong commitment and good work ethic are essential. Levels can be flexible based on experience.

1) Prepare technical reports 2) Interpret gas chromatograph mass spectrometry (GCMS) and liquid chromatograph mass spectrometry (LCMS) results with a high level of proficiency 3) Interpret chromatographic data including high performance liquid chromatography (HPLC), gas chromatography (GC), and gel permeation chromatography (GPC) results 4) Combine results from multiple techniques to identify unknown chemical compounds 5) Quantify chemical components using HPLC and GC results 6) Work with a team of scientists to design and implement analytical strategies 7) Perform or oversee complex analytical strategies with an emphasis of MS and chromatography 8) Review technical reports written by other scientists

Responsibilities: Set up experiments under the guidance of a Scientist II and/or Team Lead Operate equipment, observe and log the progress of experiments. Promptly submit experimental data / findings to the supervisor. Promptly inform the supervisor of any problems encountered during the experiments. Assist in data entry in various formats and verify accuracy of data entry. Assist in writing drafts of Protocols and Reports.Responsibilities: Set up experiments under the guidance of a Scientist II and/or Team Lead Operate equipment, observe and log the progress of experiments. Promptly submit experimental data / findings to the supervisor. Promptly inform the supervisor of any problems encountered during the experiments. Assist in data entry in various formats and verify accuracy of data entry. Assist in writing drafts of Protocols and Reports.

The Operations Coordinator will be involved in the management of services and processes that support the core business of the organization, ensuring the organization has the best working environment for its employees and their activities. The Operations Coordinator will continually work on improving the critical activities required for the efficient and effective functionality of the lab.

Just is seeking a motivated and creative researcher who desires a significant opportunity to improve worldwide access to biotherapeutics. This position is a hands-on, laboratory based role supporting all stages of formulation development from early stage formulation verification to late stage, commercial formulation design of antibodies, Fc-conjugates and other novel protein based molecules. The successful candidate will have experience working in an analytical laboratory setting and be familiar with chromatographic, electrophoretic, and spectroscopic techniques. Experience with high throughput, robotic techniques, statistical design of experiments, and data modeling is a plus. The candidate must possess a strong ability to work in a team while supporting multiple projects. Strong organizational, written, and verbal communication skills are necessary. The ideal candidate is efficient, curious, creative, enthusiastic, works well independently and in teams, and looks for ways to improve processes and technology.

Just is seeking a motivated and creative Associate Scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work with a multidisciplinary team for the analytical and functional biocharacterization of large molecule therapeutics and analysis of process impurities. Experience with ELISA binding assays, DNA extraction, and PCR preferred. Additional experience with cell-based and ligand-receptor binding assays, as well as high-throughput methods and liquid handling robotics beneficial. The successful candidate has strong written and verbal communication skills and is interested in ways to improve technology. The ability to multitask and to work both independently and in teams in a fast-paced collaborative environment is necessary.

Just is seeking a highly motivated Materials Engineer in the Manufacturing Technical Operations group that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to work with operations to develop, procure, commission and test single use assemblies and manifolds for our flexible manufacturing facilities. Candidate will coordinate with supply groups to bring components into the facility and with the Quality group to develop operating procedures and specifications for the materials. In addition, the candidate will be responsible for supporting the evaluation and introduction of new single use manufacturing technologies, including assessments of leachables and extractables, and assisting with the commissioning and validation of new process equipment in the facility.

Just is seeking a highly motivated and creative Associate Scientist that desires a significant opportunity to help invent the technologies required to improve worldwide access to biotherapeutics. This position will be part of a cross-disciplinary team discovering therapeutic antibodies from display libraries and optimization campaigns. The successful candidate will support the invention, design, and implementation of cell-based, functional bioassay and immunoassay methods to drive biotherapeutic development.  A strong foundation in assay development, cell biology and molecular biology is required for this position, with additional experience in antibody discovery, target validation, in vivo PK models and automation preferred. This individual must also possess strong communication and collaboration skills, a desire to learn new scientific concepts and domains, and an ability to work directly with scientific staff across multiple disciplines.

Just-Evotec Biologics is seeking an energetic, team-oriented researcher for a hands-on, laboratory based role supporting all stages of drug product development from early stage molecular design to formulation verification and commercial stage formulation design of protein therapeutics. The successful candidate will have experience working in an analytical laboratory setting and familiarity with biophysical, chromatographic, electrophoretic, and spectroscopic techniques. The candidate must possess a strong ability to work as a team member while supporting multiple projects. Strong organizational, written, and verbal communication skills are necessary. The ideal candidate is efficient, curious, creative, enthusiastic, works well independently and in teams, and looks for ways to improve processes and technology.

Just is seeking a motivated and creative Associate Scientist, who desires a significant opportunity to improve worldwide access to biotherapeutics.  We are looking for a motivated scientist to join a fast-paced, collaborative, and multidisciplinary team.  As a member of the High Throughput Analytical group, you will support process development through application of H/UPLC and CE methodologies.  Additional experience with other analytical techniques as well liquid handling robotics is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams. 

Kallyope is seeking a self-motivated chemist to work as a member of an integrated team focused on the discovery of new drug targets leading to transformational therapeutics.  The successful applicant will assume primary responsibility for maintaining Kallyope’s internal compound collection and coordinating compound logistics. They will also contribute to drug discovery and formulation efforts through synthesis and basic physicochemical characterization of compounds. This represents a unique opportunity to impact multiple therapeutic programs driven by Kallyope’s cutting-edge biology on the gut and gut-brain axis.

The Biomarker Research Associate will be a member of a team charged with establishing a suite of biomarker assays to asses target engagement of investigational drugs in early clinical development. Candidates must be highly motivated with previous experience working in a regulated environment following established SOP’s. Successful candidates must be able to work effectively both in a collaborative setting and independently while possessing outstanding written, visual, and oral communications skills.

The In Vitro Pharmacology Research Associate will be a key member of the team charged with cell line development and maintenance for in vitro assays. Candidates must have a biology background and an extensive experience in tissue culture techniques. This role will be responsible for the majority the tissue culture work of the group. Experience with molecular biology, GPCR signaling and in in vitro pharmacology is a plus. Successful candidates must be able to work effectively both in a collaborative setting and independently and possess outstanding written, visual and oral communications skills. 

As a Research Associate you will work alongside scientific leaders in NGS-based infectious disease diagnostics providing meaningful contributions to making an impact in the lives of patients while contributing to the company’s growth and development . You will be responsible for maintaining process excellence for a state-of-the art NGS infectious disease diagnostic assay by assisting in an established in-house manufacturing process. You will be also involved with several exciting research projects and be at the forefront of non-invasive diagnostics working alongside our scientists to deliver new products. The ideal candidate should have experience with nucleic acids, NGS, or other molecular biology assays to conduct laboratory experiments on research projects under the direction of senior lab personnel.

Responsibilities: Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals. Makes detailed observations and carries out elementary data analysis. Understands experiments and conducts troubleshooting analysis. Maintains and updates knowledge of instrumentation. Notebook upkeep and writing skills. Maintains familiarity with current scientific literature; maintains professional expertise through familiarity with scientific literature.

The Manufacturing Systems Analyst will be required to resolve routine requests that may include project/folder creation, system backups, account requests, etc.; as well as troubleshooting and resolution of complex issues related to Manufacturing Systems. The position will require the interaction with end users to ensure that all end-user requests are fulfilled and issues are resolved in a timely manner. The Manufacturing Systems Analyst must be customer focused and a good communicator.The Manufacturing Systems Analyst will be required to serve as the Subject Matter Expert (SME) on Projects relating to the installation, validation and deployment of laboratory and manufacturing systems. The position requires basic knowledge of the Computer Systems Validation (CSV) process and will assist in the writing and execution of CSV deliverables as required.

The candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility. They will be exposed to cell culture media preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest setup and operations, and aseptic technique; as well as to cell culture analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolarity meters). Following task execution, the Manufacturing Associate I/II will review the executed production records (SR's, ERP, and BR's) to ensure GxP compliance.

The new associate will actively participate in a dynamic laboratory environment, learning cutting-edge analytical techniques, developing data analysis tools, establishing direct relationships with clients, and continuing to build a world-class specialty analytical business.

This role will have hands-on responsibility for assisting in the technical conduct of a wide range of Nonclinical Safety Studies, from discovery through development Projects.  The Research Project Manager will contribute to the Nonclinical Safety program activities, including short- and long-term planning, budgeting and managing expense priorities, SOP development, archival retention, process improvements, and study tracking.  This position will also contribute to the conceiving, developing, managing, directing, and organizing activities for study coordination and assist in the development of nonclinical safety studies. The incumbent should have basic knowledge of drug development principles, drug safety testing and regulatory guidelines. This position will report to the Head of Nonclinical Safety.

Keystone Nano is looking for a Research Technician able to play an important role in developing novel drug products. The successful candidate will join their laboratory in State College, PA to expedite work flow and maintain a positive team environment. 

Reporting to the Associate Clinical Project Manager, the Clinical Trial Associate (CTA) will be tasked with providing clinical trial coordination support, along with implementing the clinical operational plans in accordance with regulatory guidelines and ICH/GCP standards. The CTA will be responsible for providing Clinical Operations support of study specific reports and site and vendor management activities.

As a Process Engineer for Manufacturing Sciences and Technology (MSAT), you will provide process science support for commercial GMP manufacturing, technology transfers, development studies, validation, and continuous improvement projects for Kite’s engineered T cell therapy products. Additionally, you will write product impact assessments, root-cause analysis reports, sampling plans, technical reports, and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.  

We are seeking a highly motivated Research Associate to join Kite’s research team at our Emeryville, CA, location. Specifically, you will be part of the Protein Sciences team, supporting our early pipeline through generation and characterization of critical recombinant protein tools. You will work in a collaborative cross-functional team environment as you support our on-site protein production capability.

Korro Bio is seeking a passionate, driven, and creative entry-level scientist to join our oligonucleotide discovery chemistry team and work with an enthusiastic team of highly skilled scientists in a dynamic, growing company. The successful candidate will be responsible for oligonucleotide analysis and independently assist in tracking, receipt, handling, organization, sample preparation, storage and distribution of oligonucleotide compounds and work closely with cross functional team to advance our RNA editing drug discovery programs. The candidate will also be responsible for quantifying, performing purity analysis via HPLC/LCMS, and documenting results. Additional responsibilities include maintaining an active inventory of compounds, both physical and virtual. Candidate must express a high attention to detail, be comfortable multitasking and ability to function in an interdisciplinary and fast-paced startup environment.

Responsible for the design, execution and analysis of a variety of in vitro cellular and molecular based assays, focused on understanding and optimizing a ADAR-mediated RNA editing platform.

Krystal Biotech, Inc is seeking a highly motivated Research Associate to perform high quality analytical development to support research for gene therapy products. This position will be laboratory based.

Krystal Biotech, Inc is seeking a highly motivated Research Associate to perform high quality analytical development to support research for gene therapy products. This position will be laboratory based.

KSQ Therapeutics, Inc. is seeking an exceptional and highly motivated scientist to apply their experience in oncology towards the discovery of the next generation of impactful therapies. This person will contribute to cell biology and translational efforts for our drug discovery pipeline. This skilled scientist will characterize novel cancer pathways and develop assays for drug targets. They must be driven and flexible with the broad number of in vitro, in vivo, and biomarker activities associated with cancer drug discovery. This is an opportunity to learn, contribute and flourish in KSQ’s dynamic, highly interdisciplinary, and collaborative environment.

We’re looking for a Research Associate to join our growing team. This is a newly created position due to company growth. The Research Associate will support scientists with day-to-day management of laboratory and experiments involving cell biology, molecular biology, and biochemistry techniques. Training and mentoring will be provided for the skills and knowledge involved. This is an excellent opportunity for those who are motivated, eager to learn, and adapt quickly to changing needs in the lab.

Kymera is seeking a highly motivated Senior Research Associate/Research Associate, in vivo Pharmacology to support our discovery and development efforts. The successful candidate will be required to execute all aspects of pre-clinical in vivo studies including dosing, tissue collection and data analysis, to advance their preclinical research. This individual should have extensive hands-on experience with in vivo procedures in rodents.

Monogram Biosciences, part of LabCorp, is seeking a Laboratory Technician to join its team in South San Francisco! This position will be responsible for working with automated and semi-automated equipment specifically working with cell-based assays from introduction of virus, cells and drug addition to the final read step. This is a great entry level opportunity to join an innovative laboratory and receive targeted one-on-one training that will help the individual grow in a career in the biotechnology field. The schedule for this position will be Monday -- Friday, 3pm-11:30pm with rotating weekends (one month on, one month off). Training will be: Monday-Friday, 6am-230pm for the first few months.

LabCorp is seeking a Technologist Trainee to join our Chemistry lab team in Burlington, NC. The large range of assays within the department can be categorized into: General/Routine Chemistry, STD testing, Therapeutic Drug Monitoring, and Clinical Endocrinology, with the overall goal of providing results that can be used in the diagnosis and management of a wide range of illness and disease states. All of our assays are automated and our department includes some of the most advanced high-throughput analyzers available on the market. We are currently looking for individual(s) who are looking for an opportunity to get their career started and have the ability to grow within the company. The work schedule for this position will be Monday - Friday, 8:30 am - 5:00 pm.

The ideal candidate will support cGMP method validation, equipment validation, qualification and release testing for raw materials, drug substance and finished product testing for products produced at Lake Pharma’s GMP manufacturing facility and affiliated contract organizations. The individual will have a focus on Microbiology and Chemistry, including Bioburden, Endotoxin, Sterility, TOC, Environmental monitoring, PW/WFI water collection regulations, clean room experience and Micro id. He/she will develop methods, qualify and validate equipment and support investigations for OOS and other non-conforming results. He/she will contribute to the implementation of testing capabilities, related validation and qualification activities, investigations and assay/instrument troubleshooting with a high degree of independence.

This position is primarily responsible for the laboratory testing of in-process, release and stability samples for commercial drug products.

An ideal candidate would be familiar with validation and parenteral products. Have strong technical skills in problem solving and aseptic manufacturing processes. Be able to use project management skills to lead cross functional teams through data based decision making for technical transfers or project improvements. Support larger projects collaborating across multiple teams. Strong partnership skills to build and maintain relationships. Be able to handle varied tasks supporting group projects and routine manufacturing.

The Defense Health Operation of Leidos is currently looking for a Research Associate to support biomedical research at the Naval Medical Research Unit, San Antonio (NAMRU-SA) in San Antonio, TX.

Leidos Military & Veterans Health Solutions Group is seeking a Test Engineer to support our operations at the Naval Submarine Medical Research Laboratory (NSMRL) in Groton, CT.

The Oligo Production Technician I is responsible for performing day to day production activities in the custom oligonucleotide (oligo) production lab. Production activities will be performed in a timely fashion and in compliance with company procedures.

This role requires and individual with background in analytics and managing data; however will also have a laboratory management role to oversee groups tasked with providing the measurement data as well as document generation. Position is a new role for developing the integration of data streams from multiple analytical instruments, as well as internal manufacturing department data, carry out-processing using common statistical methods and oversee its transfer into reports. It is an impactful position that is well suited for an individual with a background in data integration and computer skills to apply to a range of non-routine analytical chemistry applications for materials and other industrial samples. Position will initially work alongside company ERP system, but longer term to develop LIS software that may require considerable customization; hence, light programming experience is desirable.

The Instrumentation Technician is responsible for maintenance and repair activities associated with the Oligonucleotide manufacturing equipment. This includes creating documentation for maintenance activities, performing the maintenance activities, and training production staff to perform maintenance activities. Responsibilities will also include recommending and implementing improvements to the system. This position will report on the status and key metrics of the equipment. 

We are seeking individuals who are passionate about research, bring out of the box thinking and take bold steps to develop innovative technologies with applications in the ubiquitin research field. Successful candidates will have basic knowledge of biochemistry and molecular biology techniques, in particular experience with protein expression and purification and cloning. Knowledge of the ubiquitin proteasome pathway is desired.

We are seeking a Research Associate for our Cambridge site to join our Synthetic Biology team. The Research Associate will be involved in developing and operating our platform for the high throughput engineering of filamentous fungi for the identification and production of natural products to further LifeMine’s fungal genomically enabled drug discovery platform.

(position level depends on experience; we are looking to fill 2 positions within this department) The Senior Research Associate works under the direction of a senior level scientist supporting Ligand’s OmniAb Technology Platform with responsibilities in multiple research areas including: generating and characterizing new strains of OmniChickens; conducting OmniAb antibody discovery campaigns for internal and partner programs; preparing custom protein reagents for immunization and screening; antibody engineering and optimization of lead molecules for further development.

Under minimal/no supervision develop and validate analytical methods to support product development, release testing and stability activities for pharmaceutical drug product programs. Perform physical and chemical tests on active pharmaceutical ingredients, raw materials, in-process, and finished products using various wet chemical, physical and instrumental techniques. Hands on experience with HPLC/UPLC with various detectors, related spectroscopy, KF (Karl Fisher), dissolution, and other common analytical methods. Conduct laboratory experiments in support of formulation and process development. Assist/perform manufacturing preclinical formulations and early clinical supplies. Generate and collate the data, perform required calculations and document experiments and results in a laboratory notebook following GMP/GLP practices. Critically assess experimental data and provide interpretation of results. Author SOPs, technical reports such as method development/validation, formulation report and other relevant scientific information packages for internal use or agency submissions. Prepare drug product stability protocols and reports. Evaluate the stability data and trends. Ensure the cleanliness, calibration and maintenance of laboratory equipment/stability chambers and work areas to ensure compliance with SOPs, GLPs and cGMPs.

Locus Biosciences has an immediate need for a highly motivated and experienced applicant to join their team as a full-time Development Specialist or Development Scientist responsible for developing biologics purification processes and formulations, as well as supporting early phase clinical trial material manufacturing in an aseptic environment. This position is well suited for those that have demonstrated laboratory experience, with solid communication, technical aptitude and problem-solving skills.

Locus Biosciences is seeking a highly motivated and entrepreneurial applicant to join their team as a full-time R&D Project Manager responsible for developing, maintaining and executing research plans across Locus Biosciences. The incumbent will be able organize and drive projects across Locus Biosciences to completion, including cross-departmental projects spanning the drug development pipeline. This role requires an ability to interact with technical staff and consistently translate drug development activities across our teams into visible project plans. This person will be responsible for managing detailed project plans across multiple programs, including developing and updating Project Gantt charts, leading status update meetings, and ensuring good cross-team communication.

LogicBio is seeking a highly motivated team member who will assist the team with the in vitro and in vivo assays related to developing gene therapy products.  Specifically, the successful candidate will be involved in maintenance, expansion and banking of cell culture lines, in vitro and in vivo analytical and functional bioassays for characterizing internal and external AAV vector product, molecular quantification assays, potency assessment and biodistribution studies.

LogicBio is seeking a highly motivated team member who will assist the team with the in vitro and in vivo assays related to developing gene therapy products. Specifically, the successful candidate will be involved in maintenance, expansion and banking of cell culture lines, in vitro and in vivo analytical and functional bioassays for characterizing internal and external AAV vector product, molecular quantification assays, potency assessment and biodistribution studies. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in an efficient, highly interactive, goal-oriented team environment, and working with minimal supervision.

LSI is seeking a Control Systems Engineer in the Metro Atlanta GA area to design, develop, install, commission & maintain state-of-the-art process control computer systems for the wood protection business, and provide remote system support to customer base in order to maintain optimum production.

The purpose of this role is to support the Quality Control, Environmental Monitoring (EM) team in maintaining the cleanrooms for commercial manufacture for both At Rest and In Operation conditions. This role will also be central in all processes associated with environmental monitoring and integral with environmental investigations, excursion report writing, and general upkeep of the micro department.

The Research Associate provides technical support to lead scientists in conducting analytical tests for the evaluation of cellular products and in support of process development activities.

The MSAT Engineer/Scientist will play a crucial role in Bioscience by leading Tech Transfers, complex technical investigations, and process improvements. This individual is the key process knowledge holder who drives the proactive life-cycle management through continuous and systematic optimization of production processes. The MSAT Engineer/Scientist is responsible for the incremental improvement of a process, but also ensures excellent process understanding and process robustness. As well as provides technical expertise in process risk assessment, technical complex investigations, CAPA management. Acts as a Subject Matter Expert in any of the following unit operations: Aseptic processing, cell culture, mixing, filtration/filling/finishing.

The individual will provide next generation sequencing service to customers that incorporates Loop Genomics's long read technology with Illumina's short read sequencing platforms. This includes applying the standard operating procedure during NGS library preparation, as well as custom solutions tailored to the specific sequencing projects. The individual will also assist in testing and improving the robustness of Loop Genomics’s library preparation kits. This role requires excellent laboratory liquid handling skills and consistent performance of various wet lab operations. The individual will provide next generation sequencing service to customers that incorporates Loop Genomics's long read technology with Illumina's short read sequencing platforms. This includes applying the standard operating procedure during NGS library preparation, as well as custom solutions tailored to the specific sequencing projects. The individual will also assist in testing and improving the robustness of Loop Genomics’s library preparation kits. This role requires excellent laboratory liquid handling skills and consistent performance of various wet lab operations.

The Scientific Data Analyst will be responsible for the review and entry of data generated in a Discovery laboratory setting.  The Scientific Data Analyst works with biologists, chemists, and scientific systems group to develop and maintain strategies to ensure integrity of published data. 

The successful candidate will work as part of a collaborative team of scientists with expertise in protein production, cell culture, chemistry, biochemistry, structure, and biophysics, supporting hit-to-lead and lead-ID phases of Loxo oncology drug programs. The candidate will have opportunities to learn cutting edge techniques and to learn and develop technical expertise in protein biochemical and biophysical characterization.

Regulatory Associates assigned to Domestic Regulatory Projects will contribute to regulatory submissions, including FDA Q-Submissions, 513(g) Submissions, and 510(k) Submissions as required to market LSI’s new or modified medical devices in the U.S., including all relevant maintenance activities; and assist in providing regulatory feedback and guidance to the company throughout our medical device design and development process.  Regulatory Associates assigned to Global Regulatory Projects will work with distributors to provide documents for regulatory submissions required to market LSI’s new or modified medical devices outside the U.S. 

This individual will perform quality engineering tasks for new & existing product and process development and improvement initiatives. Quality Engineers are specialized in either Supplier Quality Engineering, Design Quality Engineering, Metrology Quality Engineering or Finished Goods Quality Engineering. Quality Engineers interface with other functions within an organization and with internal and external customers and suppliers on quality-related issues.

Responsibilities: Executes experiments under direct supervision supporting Process Development projects. Accurately follows and completes required documentation (batch records, forms). Expected to adhere to all procedures, including gowning and safety requirements, at all times. Assists in troubleshooting development equipment, as assigned. Completes all required training in a timely manner Collaborates with Process Development Scientists and Management during technical transfer and experiment design.

The Quality Engineer is primarily responsible for assuring product and Quality Systems quality and compliance through the development, implementation and monitoring of appropriate processes, tools, metrics and goals.  The Quality Engineer is the process owner for the site CAPA program, process validations, Customer Complaints, NCRs, CAPAs, Internal Audits, and assigned New Product Development programs.