Director, Analytical Development
2 weeks ago
Orbital is seeking an experienced Director of Analytical Development who will be responsible for leading, directing, and implementing a comprehensive analytical strategy in support of programs within vaccine, immunomodulation, and protein therapeutics. This highly accountable, high integrity individual will also lead, motivate, and grow the Analytical Development team.
Responsibilities:
- Lead an Analytical Development team consisting of scientists and associates.
- Define and execute a phase-appropriate analytical strategy in support of programs as they advance through various phases of research and development, including establishing methods/specifications for the release and characterization of drug substance and drug product, as well as stability and comparability studies.
- Provide direction/oversight of analytical activities conducted at CDMOs by evaluating/assessing analytical capabilities, leading tech transfer of analytical methods developed internally, coordinating method development externally, oversight of QC testing and stability programs, and review of CDMO-generated analytical documentation (e.g., SOPs, method validation protocols, stability reports, change controls, etc.)
- Collaborate with regulatory and QA experts, contributing to regulatory filings by assisting in the writing and/or reviewing of analytical sections.
- Lead the method development and routine testing functions for internal teams, including process development (drug substance and drug product), preclinical manufacturing, and the Research organization (RNA science, LNP science, immunology).
- Communicate effectively and respectfully both internally and externally across all levels to help make/influence key decisions with supporting information and rigorous data.
- Monitor industry trends (technological and regulatory) to remain current on best practices.
- Ph.D. or M.S. in Chemistry, Biochemistry, or a related field is required. Ph.D. is preferred.
- 8+ years of relevant experience in the biotech/pharma industry is required, including 5+ years managing direct reports in Analytical Development.
- Previous experience managing QC and/or routine testing for preclinical materials/research is a plus.
- Direct experience and deep technical expertise in developing analytical methods for the characterization and release of biologics is required, with strong preference for experience with RNA, LNPs, VLPs, and their raw materials and impurities.
- Experience using a combination of internal and external resources to accomplish goals, including tech transfer to, and management of, analytical/QC activities at CDMOs, CROs.
- Experience with stability program design and oversight is required.
- Familiarity and understanding of regulatory standards and current best practices, including GMP, ISO, and ICH guidelines.
- Strong technical writing skills and experience creating documents in support of tech transfer and regulatory submissions (e.g., preIND, IND, BLA, etc.).
- Excellent project management and operations management skills as applied to Analytical Development and QC.
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