Senior Scientist, Bioassay, Analytical Method Development

Manager: Associate Director, AMD

Department:  Analytical Development

Location: Sangamo Therapeutics (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 about 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. Sangamo is a company where individuals can flourish, grow, and develop their expertise.

We are seeking top talent to join our team. Let’s build a better future together.

JOB SUMMARY 

 The Analytical Development (AD) senior scientist will perform laboratory-based activities to design, develop and qualify analytical methods for the characterization, and release testing of the company’s recombinant Adeno-Associated Virus (rAAV) gene therapy, genome editing, and cell therapy products. Ideal candidate will be experienced and should independently perform biological assays to measure potency, molecular based assay and characterization assays for product characterization.

The successful candidate will develop, qualify and method transfer phase appropriate molecular biology strategies for the lot release, stability, and characterization testing for gene therapy products. They will participate on cross-functional project teams (internal and cross department) and represent the AD function in a CMC sub-team representative capacity.  

The level of this position will be based on the final candidate’s qualification.

RESPONSIBILITIES

• Development, optimization, and qualification of biological assays for gene & cell therapy product characterization, lot release and stability testing
• Develop and qualify cell-based bioassay/potency assays, characterization assays, establish assay acceptance criteria and product specifications applying appropriate statistical tools and comply with regulatory guidelines
• Conduct the analytical characterization of products including preparation of reference standards, assay development plans, DOE and statistics for data analysis
• Design and execute laboratory-based analytical assay development, optimization and qualification for the Company’s gene and cell therapy drug products
• Evaluate new assay technologies and innovate novel assay/methodologies that could improve existing analytical methods for CMC activities
• Compliant with GxP, keep good lab notebook and experiment records. Authoring and review of SOPs, Development Report, and assist in the preparation of CMC regulatory submissions
• Transfer of methods and training of staff within the in-house QC department.
• Participate and present at internal and external scientific meetings and conferences, including both written and oral presentations of data 

QUALIFICATIONS

• PhD degree in Cell biology, Biochemistry, or related disciplines with 8+ years of experience, preferably in biotech or pharma industry with primary focus on biologics.
• In depth knowledge of understanding the mechanism of action (MoA) of biologics and experience in design, and development of mechanism of action (MoA) reflective bioassays using appropriate technologies, such as cell based, ELISA and enzymatic assays experience is required
• Knowledge of FDA, cGMP, and ICH regulatory requirements in the context of bioassay/potency assay development and qualification is desired.
• Experience and knowledge of QC and GMP regulations is essential.
• Experience with method transfer to both in-house QC and contract organizations (CDMO/CTOs) is required
• Extensive experience in cell culture, cell line development is required. FACS experience is desirable but not required.
• This position requires capture of every detail of bioassay development in the form of electronic notebook.  Should be able generate the SOPs, technical reports, and bioassay assay trending.
• Prior experience or technical knowledge in molecular assays such as qPCR, ddPCR and NGS would be good to have but not essential for this position.
• Good understanding of statistical methods/tools for data analysis is strong plus.
• Team player, good interpersonal and organizational skills.
• Excellent written and oral communication skills is required.

The level of this position will be based on the final candidate’s qualification.

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.
 

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