Unknown Company
Responsibilities
- Manage and oversee method development, validation, and transfer for biologics products at CDMOs/CROs.
- Oversee specification setting of drug substance and drug product at CDMOs/CROs.
- Author/review analytical method validation protocol/report, method transfer protocol/report and SOPs.
- Manage reference standard program for drug substance and drug product.
- Review controlled documents such as batch records and CoAs.
- Assist in OOS and OOT investigations. Perform root cause analyses and recommend corrective actions.
- Contribute and act as the technical subject matter expert in preparation of regulatory submissions related to drug substance and drug product analytical package, characterization, reference standard.
- Provide scientific and technical support to internal and external groups to ensure that products are manufactured and released in compliance with all applicable regulations.
- Additional duties assigned as needed.
Education/Experience Requirements:
- B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences discipline required. M.S. degree preferred. Equivalent combination of education and applicable job experience may be considered.
- 8+ years of relevant experience in analytical development of biologics, preferably in late-stage drug development.
- Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS and other relevant analytical methods. Experience with PEGylated and/or lyophilized products is a plus.
- Extensive analytical development, validation and transfer background with experience reviewing analytical data and managing analytical development activities at external CDMOs/CROs.