Senior Scientist, Bioassay Development Lead
The Position:We are seeking an experienced scientist to build and lead Bolt’s CMC bioassay function. You will be responsible for development and optimization of cell-based and target-binding potency assays to support the development and characterization of Bolt’s Boltbody™ Immune-stimulating Antibody Conjugates (ISAC). You will provide scientific leadership and act as the subject matter expert for the CMC team. You will build a laboratory infrastructure and recruit, develop, mentor, and manage a team of research associates and/or scientists. This newly created position reports directly to the Head of Analytical Development.
About You:You will have a Ph.D. degree in Biology, Cell Biology, Biochemistry, or related field, with at least 8 years’ experience (BS/MS degree with extensive industrial experience will also be considered) 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 MoA reflective bioassays using cell based and ELISA assays are required. Extensive experience in cell culture, cell line development is required. Experience in immunology and myeloid activation is highly desirable. Knowledge of FDA, cGMP, and ICH regulatory requirements in the context of bioassay development and qualification is required. Experience and knowledge of QC and GMP regulations is required. Experience with writing SOPs, training, and method transfers. Experience supporting Regulatory filings and writing INDs is a plus. Ability to multitask and meet deadlines in a fast-paced environment. Ability to think critically and demonstrate troubleshooting and problem-solving skills. 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.
Who We Are:
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics that have eliminated tumors following systemic administration in preclinical studies while also developing immunological memory, which may lead to more durable clinical responses for patients. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancers.
We are an Equal Opportunity Employer offering a competitive salary and benefits package.