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Akebia Therapeutics SR Drug Substance Ops Mgr in Cambridge, Massachusetts

The Senior Drug Substance Operations Manager is a newly created role in our Technical Operations team and will spearhead the successful validation, technical transfer activities, and process optimization of drug substance. The ideal candidate is self-motivated, enthusiastic, and a team player with a passion for playing a key role in the development of life-saving medicines. Required Skills Lead validation, technical transfer activities, and process optimization activities at Akebia CMO?s Oversee the routine manufacturing activities at Akebia?s CMO?s Lead deviations, investigation, CAPAs as the technical SME internally and at Akebia?s CMOs Review and approve documents related to GMP operations as requested including DP development/validation protocols/reports, Master Batch Records, Executed Batch Records, campaign summary reports, and stability summary reports. Identify and select new commercial CMOs for Akebia?s drug substance manufacturing Design and develop related manufacturing process improvements including scale-up, technology transfers, validation and troubleshooting of process-related issues. Serve as the technical point person with contract manufacturing sites. Working with the Drug Substance Development team, support late-stage product development activities Participate in preparation, review and approval of CMC sections for regulatory filings Participate in periodic business and technical review meetings with relevant DP CMOs Clearly communicate progress and collaborate with internal cross-functional development teams to ensure alignment with overall asset development and filing plans Travel to various CMO sites (circa 20%) Required Experience Basic Qualifications: B.S. and 10+ years of experience in pharma or biotech OR M.S. and 8+ years of experience in pharma or biotech OR PhD and 6+ years of experience in pharma or biotech Preferred Qualifications: Degree in Organic Chemistry, Chemical Engineering or related discipline 5+ years of hands-on experience in drug substance late stage development and validation Technical depth in drug substance process development and validation of small molecules Understanding on how to set and justify drug substance specifications with the understanding of CMC processes