Associate Director, Analytical Development (Bioassay & Molecular Biology)
Manager: Sr. Director, Analytical Development
Department: Analytical Development, Technical Operations
Location: Brisbane, CA
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our mission. Let’s build a better future together.
The Associate Director will develop analytical methods to support the development of company’s genomic therapies, including genome editing, gene regulation, gene therapy and cell therapy. The Associate Director will lead the assay development to design, develop, pre-qualify, and transfer analytical methods to internal and external quality control laboratories for lot release and stability testing. In addition, they are responsible for designing and implementing biological and molecular biology related orthogonal methods for product quality characterization.
The ideal candidate for this position will have demonstrated in-depth knowledge & experience of the developing analytical methods for biologic products in an industry setting. They will provide subject matter expertise and leadership in the development of analytical methods for gene and cell therapy product characterization and release testing. Primary managerial responsibilities are to oversee a team dedicated to biological potency assay and molecular biology method development. They will also identify and evaluate new technologies within the field to maintain the department’s and company’s competitive advantage.
The Associate Director will also be responsible for being an analytical development representative on product specific CMC teams and coordinate all analytical development activities for that product across the specialty groups within and outside of the department. As part of this responsibility, they will also take lead authorship and or review/editing roles for module 3 analytical section for drug substance and product in support of regulatory filings.
- Lead activity for development, optimization and qualification of biological and molecular biology based analytical methods for gene & cell therapy product characterization, lot release and stability testing
- Lead a team of scientists / associates in developing, qualifying, and implement cell-based biological assays and molecular biology-based assays, especially next generation sequencing and accompanying bioinformatics, as well as other analytical assays for all drug modalities within Sangamo to support process development and QC release
- Function as technical resource and SME for analytical method issues. Guide the analytical characterization of products including preparation of reference standards, assay development plans, DOE and lead the design and execution of comparability studies for multiple programs
- Manage and participate in tech transfer of analytical methods to CMO’s/CRO’s
- Authors development report, SOPs, and author/review module 3 sections related to analytical methods for regulatory filings. Develop and deliver scientific presentations, participate in project teams, provide leadership in CMC team
- Execute all aspects of people leadership, including performance evaluations, mentorship, and ensure effective development plans for all team members
- Act as a CMC Team analytical lead on product specific CMC Teams and coordinate all internal and external analytical method activities to ensure the success of the program.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Ph.D. in Cell & Molecular Biology, Biophysics, Biochemistry, or a related discipline
- 10+ years of experience in the biotechnology or pharma industry with a primary focus on bioassay method development for biologic products
- AAV-mediated gene therapy, gene editing and cell therapy experience is highly desired
- Hands on experience in cell-based bioassay, qPCR, ELISA, qPCR, ddPCR, Seq/NGS, enzyme activity assay, FACS, and fluorescence -based method development
- T-cell, iPSC and immune oncology method development experience is plus
- In-practice knowledge of the USP, ICH for bioassay qualification and validation. Knowledge of FDA cGMP requirements are must
- Previous experience contributing to or authoring module 3 sections for regulatory filings
- Experience in experiment design (DOE), data statistical analysis and stability studies are required
- Ideal candidate must be team focused and have strong collaboration, communication, interpersonal and organizational skills. Excellent written and oral communication skills
Sangamo is an equal opportunity employer
The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.
Note to External Recruiters: Please understand that we do not accept unsolicited resumes from any source other than from the candidates themselves. Any agency or independent recruiter must have a signed copy of our agency agreement before presenting candidates. Submission of unsolicited resumes without our signed agreement will not create any implied obligation on our part.
If you wish to be considered for the presentation of candidates, please contact us through Recruiting@sangamo.com. Attach your contact information, your area of specialty, and any marketing information you wish to provide. Someone from the Talent Acquisition Department will contact you directly if there is a business need for your services.