Research Associate I/2 - Cell-Based Potency Assays (Contract)

Location
Emeryville, CA
Posted
Jul 05, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics is located in Emeryville, CA.

GENERAL SUMMARY:
4DMT needs a motivated, detail-oriented, and experienced Research Associate I/II (Contactor). 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. 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 9-month contract CMC position, and the level will be determined based on the candidate’s experience and qualifications. This position reports to the Associate Director, Analytical Development and Quality Control.
Responsibilities:
  • Lab work/experimental/data analysis - 70%
  • Develop, optimize, and execute under limited supervision phase-appropriate bioassays and broad spectrum of characterization assays including cell-based, nucleic acid-based, ELISA, and enzymatic assays based on thorough understanding of the scientific background of the analytical procedure, product, applicability of the emerging or existing assay platforms and phase-appropriate GMP requirements for AAV based gene therapy product
  • Maintain cell lines, prepare, and qualify cell banks including both adherent and suspension mammalian cell culture systems.
  • Support the Process Development team in transfer of new projects and scale-up of processes into GMP manufacturing. Identify and elevate processing issues (large and small) and implement solutions. Provide feedback and/or suggested changes to operational procedures.
  • Troubleshoot analytical procedures and equipment problems; work with Facilities to assist with calibration, maintenance, and operation requirements of analytical equipment.
  • Assist with the new facility expansion and equipment validation activities as needed.
  • Paperwork/documentation -30%
  • Complete and review experimental records following Good Documentation Practices, cGMP, and corporate policies to meet both operational and compliance requirements.
  • Contribute to experimental protocols, reports, internal documents including SOPs, lab records, deviations, and investigations as appropriate.
  • Work closely with supervisors and cross-functional teams for setting up and following the testing schedule to meet timelines for products release, stability, and characterization purposes.
  • Work closely with Materials Management to keep the reagents and lab supplies inventory stocked properly and within expiration.
  • Maintain a good understanding of GMP procedure for clinical production of complex biologics.
  • Follow all Quality procedures, including deviation reporting. Support deviation investigations.
  • Other Duties as Assigned.

Qualifications:
  • BS in bioprocessing, chemical engineering, biochemistry, or biology preferred
  • Biotechnology program certifications considered, as well as experience providing technician support in an academic setting.
  • Experience:
  • 2+ years of Analytical Development or Quality Control experience in biopharmaceutical industry
  • Ability to adapt and work in a small company environment
  • Skills:
  • Proficiency with cell culturing and aseptic techniques is essential. Cell-based potency experience is advantageous but not required.
  • Knowledge of molecular, cell and/or viral biology.
  • Experience working in (or awareness of) a GxP environment is advantageous but not required.
  • Excellent time management skills, ability to work independently, under minimal supervision, multi-task, adapt to changing priorities and timelines.
  • Must be a team player, detail-oriented critical thinker, exhibit a willingness to meet project timelines in a dynamic fast-paced environment.
  • Strong written and oral communication skills with demonstrated ability to present scientific ideas and information and data effectively via one-on-one discussions and team meetings.
  • Familiarity with Excel, Word, and PowerPoint. Experience with bioassay and/or statistical software such as SoftMax Pro, PLA, GraphPad, Minitab, JMP or Spotfire is advantageous but not required.
  • Physical Requirements:
  • Capable of repetitive work (pipetting/liquid transferring). Ability to lift, dispense, push and/or pull items with an average weight of 25 pounds.
  • Capable to be tested for COVID-19 and adhere to 4DMT Covid protocols and policy.
  • Work in the laboratory for Not Less Than 4 days per week.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities