Research Associate I, Cell-Based Potency Assays

Employer: 4D Molecular Therapeutics
Location: Emeryville, CA
Start date: Mar 16, 2021

Discipline: Regulatory, Research/Documentation, Science/R&D, Research
Required Education: Bachelors Degree
Position Type: Full time
Hotbed: Biotech Bay

Job Details
Company

Job Details

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. 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 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.
Responsibilities

Development, optimization, and execution under limited supervision of 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.
Cell line maintenance, banking, and development, including both adherent and suspension mammalian cell culture systems.
Cross-trained to different operational areas, e.g., buffer/ media preparation and aseptic techniques.
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.
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.
Troubleshoot analytical procedures and equipment problems; work with Facilities to assist with calibration, maintenance, and operation requirements of analytical equipment.
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.
Assist with the new facility expansion and equipment validation activities as needed.
Have a good understanding of GMP procedure for clinical production of complex biologics.
Follow all Quality procedures, including deviation reporting. Support deviation investigations.

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:

Adhere to 4DMT COVID protocols and policy
Must adopt safety and social distancing practices established by 4DMT in the lab

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

Company

4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.

At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.

While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.

At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.

4D Purpose Statement: Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients

GUIDING PRINCIPLES

Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
Break Boundaries - Question the status quo and innovate beyond conventional approaches
Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other.
Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans

We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek 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 generous benefits and provides challenging opportunities for career development.

Company info

Website: http://www.4dmoleculartherapeutics.com/
Phone: 510-505-2680
Location: 5858 Horton St. Suite 455
Emeryville
California
94608
United States

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