Senior Manager, Analytical Chemistry
New
J
JobgetherPharmaceutical Biotechnology
Based in United StatesFull-TimeManager
Salary$115,000–$135,000
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Job Details
- Experience
- Ph.D. with 6+ years, M.S. with 9+ years, or B.S. with 12+ years of relevant experience
- Required Skills
- Project Management
Requirements
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline with 6+ years of experience; alternatively, M.S. with 9+ years or B.S. with 12+ years.
- Substantial experience supporting analytical development and QC for small-molecule drugs across multiple development stages.
- Experience managing analytical activities performed by CROs, CDMOs, and contract laboratories.
- Strong knowledge of HPLC/UHPLC, dissolution, GC, spectroscopy, and mass spectrometry.
- Practical knowledge of GLP and cGMP requirements, data integrity, and ICH/FDA regulatory expectations.
- Experience investigating deviations, OOS/OOT results, and stability issues.
- Demonstrated ability to contribute to analytical CMC sections for regulatory filings.
- Strong project management skills and the ability to operate independently in a fast-paced environment.
Responsibilities
- Develop and execute phase-appropriate analytical development and control strategies for drug substance and product programs.
- Manage CROs, CDMOs, and contract laboratories, including budgets, timelines, and technical deliverables.
- Oversee the lifecycle management of analytical methods, including development, qualification, validation, and transfer.
- Critically review analytical data, validation packages, stability reports, and regulatory documentation for integrity and accuracy.
- Support impurity and degradant identification, characterization, and control strategies.
- Lead investigations into deviations, laboratory failures, and atypical results in partnership with Quality teams.
- Author and review CMC content for regulatory submissions such as INDs and NDAs.
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