Scientist 2, Analytical Chemistry - Process Analytics
The Process Analytics subgroup within the Analytical Chemistry department is seeking an experienced Analytical Chemist at the Scientist 2 level with a deep understanding of analytical/assay development to support gene and enzyme replacement therapy efforts that address genetic disorders. The candidate should be a self-motivated, independent and critical thinker who has a proven ability to work in a multi-disciplinary and collaborative environment. The ideal candidate would be well-versed in protein and viral vector analytics to develop, qualify and transfer methods to characterize the gene and enzyme replacement therapy agents in our pipeline. Collaboration with other scientists skilled in molecular biology, HPLC and mass spectrometry to develop better gene and enzyme replacement therapy products and processes will be required. Experience in a drug development environment is desired.
- Development of various analytical methods to support drug substance and drug product development at various clinical stages per ICH guidelines
- Management of the development, qualification, and transfer of analytical assays to assess viral vector and protein stability, purity, potency, and titer (e.g. HPLC, ddPCR, ELISAs, cell based assays and MS)
- Oversight of contract research organizations (CROs) for analytical method development, validation and release testing
- Preparation and/or review of written documents including technical reports, validation protocols & reports, and regulatory filings, etc
- Design, assess and interpret experimental data and present findings in cross-functional groups
- Assessment and implementation of new technologies
- Hands-on experience in the biotechnology industry with a broad range of techniques focused on viral vector and protein structure, purity, and assay development is required
- Strong background in assay qualification/validation
- Working knowledge of cGMP and ICH guidelines
- Experienced in writing and reviewing assay qualification reports, method procedures, method transfer protocols and reports and regulatory documents
- Strong communication, collaboration and writing skills
- Proven data analysis, interpretation and scientific communication skills
- Proven flexibility and execution skills to deliver in a fast-paced environment
- Experience with CMO/CRO oversight
- Understanding and knowledge of regulatory requirements for biologic and gene therapy products
- Strong attention to timelines
- Experience with cross-functional management
- Understanding of cell culture and purification process development
At the Scientist 2 level, a Ph.D. degree in Analytical Chemistry, Biochemistry, or a closely related field and 2-5+ years of relevant experience in industry.
Operation of standard analytical and biochemistry equipment including HPLCs, ddPCR, ELISAs etc.
Will report to the Process Analytics Group Leader.
May manage Associates in assay development or assay testing.