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.
The Senior Associate in Analytical Development/Quality Control (ADQC) (QC focus) is responsible for performing routine analytical testing, data analysis, and method optimization/qualification. The candidate will work closely with Process Development, Manufacturing, and Quality organizations. The successful candidate will be experienced with analytical techniques including but not limited to qPCR/ddPCR, electrophoresis, ELISA, CE (CE-SDS, cIEF), and UV/VIS spectroscopy.
Routine Sample Testing and Data Analysis: 40% of TIME
- Perform testing in support of process development
- Perform testing for release and stability under GMP
- Maintain accurate and well-organized laboratory records
- Generate technical reports using statistical analysis
- Review and present analytical data to cross-functional teams
Method Optimization and Qualification: 30% of TIME
- Transfer and optimization of analytical methods for use in Quality Control
- Drafting of analytical Standard Operating Procedures
- Drafting, execution, and reporting of analytical method qualifications
Quality System Oversight: 20% of TIME
- Maintaining a GxP-compliant testing laboratory
- Coordination and planning of Stability Testing
- Organization and maintenance of reference materials
Other Duties as Assigned: 10% of TIME
- MS degree in Biochemistry, Biology, or related field OR
- BS degree with 3+ years of experience
- Experience working within Quality Control within a regulated industry
- Strong background in assay qualification/validation under ICH Guidelines
- Knowledge of viral gene therapy (adeno-associated viral vectors) preferred
- Successful demonstrated ability to work independently and work with others in designing and developing experiments, analyzing and interpreting data in a rigorous way
- Ability to multi-task and support more than one project simultaneously.
- Understanding and knowledge of key scientific software programs such as SoftMax/QuantaSoft
- Understanding and knowledge of regulatory requirements for biologic products
- Strong organizational, analytical, and problem-solving skills
- Strong communication skills both written and oral with demonstrated ability to present ideas and information and data effectively via one-on-one discussions, team meetings, and partnership interactions
- Experience working under GXP documentation
- Sound understanding of scientific principles
- General understanding of compendial testing, ICH qualification/validation
- Strong verbal and written communication skills and effective interpersonal, technical discretion and troubleshooting skills are essential
- Must be a team player, a strong critical thinker, exhibit a willingness to meet project timelines, and multitask effectively in a dynamic fast-paced environment under challenging timelines
- Proficient or familiar with Microsoft-based Windows programs: Word, Excel, and PowerPoint
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 email@example.com– should we have a tough-to-fill role, we will contact you directly if you specialize in that area.