Associate Scientist, Cell-Based Potency Assays

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, experienced, detail- and quality-oriented Associate Scientist. This individual will join a growing Cell-Based Assay (CBA) team to develop, optimize and validate cell-based assays (bioassays) for the characterization, lot release/stability testing, and formulation assessment of AAV-based gene therapy drug substances and drug products. Associate Scientist will interface with Research, Discovery, Process Development, Manufacturing, Quality, and Facilities functional groups as well as external parties (CRO, CDMO) to support the life cycle of bioassays for current and new candidates during early- and late-stage GMP production. This is a Chemistry, Manufacturing, and Control (CMC) full-time and on-site position.

 

Responsibilities

Lab work/experimental/data analysis 70% of TIME

• Develop, optimize, and execute independently or under limited supervision phase-appropriate bioassays including cell-based, nucleic acid-based, immunoassay, and/or 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 products.

• Proficiently maintain cell lines, prepare, and qualify cell banks with emphasis on adherent mammalian cell culture systems.
• Perform independently routine testing of samples for characterization, Process Development support, and QC release/stability purpose. Provide feedback and/or suggest changes to operational procedures in a timely manner.
• Troubleshoot under limited supervision 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% of TIME

• Complete and submit experimental records following Good Documentation Practices, cGMP, and corporate policies to meet both operational and compliance requirements.
• Author under limited supervision experimental protocols, reports, internal documents including SOPs, lab records, deviations, and investigations as appropriate. Maintain and update track and trend database for the designated project(s).
• Collaborate with supervisors and cross-functional teams for setting up and following the testing schedule to meet timelines for product release, stability, and characterization purposes.
• Coordinate with Materials Management to keep the reagents and lab supplies inventory stocked properly and within expiration.
• Maintain a general understanding of GMP procedure for clinical production of complex biologics.
• Follow all Quality and Safety procedures, including deviation and non-conformance reporting. Support deviation investigations and lab maintenance.
• Work in the laboratory for Not Less Than 3 days per week.
• Other duties as assigned.

 

Qualifications

• BS/MS in a relevant area of life sciences specialization (bioprocessing, chemical engineering, biochemistry, cell/molecular biology, or similar).
• 5+ years for BS or 1+ years for MS of Analytical Development and/or Quality Control experience in the biopharmaceutical industry.
• Ability to adapt and work in a small company environment.

Required Skills:

• Proficiency with mammalian cell culturing and aseptic techniques.
• General understanding of the molecular, cell, and/or viral biology.
• Hands-on experience and in-depth understanding of the technical concepts in amolecular-based (ddPCR) and/or immunoassay (ELISA) techniques.
• Attention to details, quality, and compliance with strict adherence to test procedures and protocols.
• Excellent time management skills, ability to work independently, under minimal supervision, multi-task, and adapt to changing priorities and timelines.
• Must be a team player with an analytical mindset, detail- and quality-oriented critical thinker, and exhibit a readiness to meet project timelines and challenges 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.
• Proficient in general math and Microsoft Office applications.

Preferred Skills:

• Cell-based potency experience in the AD/QC environment.
• Hands-on experience with flow cytometry, SDS-Page/Western Blot, and protein-protein interactions.

• Experience in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DoE) principles as well as data analysis and statistics.
• Working knowledge of regulatory and industry guidelines in CMC analytical development.

• Experience with bioassay and/or statistical software such as SoftMax Pro, PLA, GraphPad, Minitab, JMP, or Spotfire.

Reports to: Associate Director, Cell-Based Potency Assays AD/QC

  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.

• Ability to sit or stand for extended periods of time and intermittent walking to gain access to work areas.
• Ability to use a computer, hard copy materials, and to complete paperwork activities (finger dexterity, vision).
• Hearing sufficient to communicate with individuals by telephone and in person.
• May be required to work during non-regular hours.
• Capable to be tested for COVID-19 and adhering to 4DMT Covid protocols and policy.

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       Attention: Search Firms / 3rd Party Recruitment Agencies* The Talent Acquisition / HR team manages the recruiting for all positions at 4D Molecular Therapeutics. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to 4D Molecular Therapeutics will be considered property of 4D Molecular Therapeutics. 4D Molecular Therapeutics will not be responsible for any fees associated should we hire from unsolicited resumes.   Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions. Recruiters interested in working with 4D Molecular Therapeutics can submit their information to recruiting@4dmt.com– should we have a tough-to-fill role, we will contact you directly if you specialize in that area.