Principal Scientist/Senior Scientist, CMC Analytical Development

Responsibilities:

• Author BLA content for commercialization programs and commercial launch preparation, including comprehensive set of specifications, method development and validation, potency and mechanism of action studies, analytical comparability studies, product stability studies
• Drive method transfer projects between the sending and receiving labs, including establishing method transfer overall plan, generation of transfer protocols, execution of transfer testing and generation of reports.
• Lead method validation of robust analytical methods for release and stability testing of cell therapy products including writing and review of protocols and reports.
• Develop and optimize immunoassays and cell-based functional assays for cell therapy products
• Perform extended characterization of product, characterization of biological activity, potency and mechanism of action studies
• Interpret experimental results and perform data analysis using appropriate software.
• Serve as subject matter expert for one or more analytical technologies such as flow cytometry, bioassays, cell counting, particle testing, potency methods
• Prepare and present high-quality data summaries and project progress updates to stakeholders and at cross-functional team meetings
• Author and review protocols, technical reports, method SOPs and regulatory submissions.
• Collaborate effectively with cross-functional teams including Process Development, Manufacturing, QC and Quality Assurance.

Requirements:

• PhD in Pharmaceutical Sciences, Biology, Immunology, Cell Biology, with 5-7 years relevant industry experience. Candidates with B.S./M.S. may also be considered with demonstrated leadership track record in Analytical development and drug product process development
• History with commercialization projects and successful track record of BLA or IND authorship is highly desired
• Experience in immune functional assays in cell therapy and/or biologics analytical development and/or quality control laboratories
• Must have substantial expertise with flow cytometry and cell-based assay technologies.
• Knowledge and broad understanding of Quality Control and cGMP requirements as they apply to the Biopharmaceutical industry. Good understanding of relevant USP methodologies and ICH guidelines
• Experience working with CMOs, CROs, contract service providers and consultant contributors
• Experience in cGMP cell therapy and/or biological product manufacturing, preferably with emphasis on immunological systems, cell therapy, gene therapy, and individualized patient therapies is a plus
• Experience working with and leading cross functional teams such as CMC teams and clinical development teams
• Outstanding written and verbal communication skills 
• Self-starter with great interpersonal skills and strong planning/tracking skills
• Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation.