4D Molecular Therapeutics, located in Emeryville is a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4D Molecular Therapeutics, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. We are seeking a Head of Analytical Development (Director/Sr Director) to join our CMC team and lead all analytical activities around release, characterization, and process development for novel AAV vectors. This individual will lead a team of Analytical Associates/Scientists
Responsibilities include but not limited to:
- Manages and mentors a team of Associates and Scientists on assay execution, development, qualification, and validation, providing scientific expertise and oversight, guidance, and development opportunities.
- Determines 4DMT Analytical priorities/strategies and guides the development process for AAV release assays (internal and outsourced), including cell-based potency and infectivity assays, Biochemical assays, titer, and DNA integrity assays, from early development through validation.
- Supports Process Development team and continuous process improvement with innovative in-process purity and titer assay development, assay characterization, and qualification
- Guides stability program and reference standard characterization for novel AAV products. Shows a thorough understanding of phase-appropriate regulatory requirements in this area and drives novel assay development as needed
- Selects hires and trains key members of the Analytical Development team
- Selects and manage CROs working on analytical assays. Works internally with members of the CMC and HCDM/R&D teams to identify analytical needs, resources, and skill sets.
- Authors assay development, qualification, and validation reports, transfer documents, and regulatory documents (IND/BLA sections). Authors manuscripts and presents results at appropriate scientific meetings
- Support the implementation of a Quality system and oversee QC testing. Manage analytical-related deviations
- Contributes to building a culture that embraces continuous learning, improvement and innovation, and encourages team members to expand their technical skill base and deepen their gene therapy expertise. Maintains a current awareness and contributes to current scientific literature; actively applies new concepts and technologies as appropriate
- Ph.D. preferred (Biochemistry, Virology, Molecular Biology, Pharmacology or related field) or equivalent experience. 15+ years experience in Analytical Development and/or QC
- Knowledge of viral gene therapy (adeno associated viral vectors preferred)
- Extensive experience with biochemical, molecular biological, structural, and cell-based potency assays, from development through validation.
- Experience leading teams of Scientists/Associates
- Ability to multi-task and support more than one project simultaneously. Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approachesUnderstanding and knowledge of regulatory requirements for biologic products
- Strong organizational skills, 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
Qualified candidates may submit a resume and cover letter to firstname.lastname@example.org