Scientist I, Early Phase Process Development

Role: Provide technical oversight and lifecycle management for externally manufactured drug substance candidates within the Process Chemistry function of CMC. Responsibilities: review and approve batch documentation, monitor process parameters and trends, lead root-cause investigations, support process improvements, coordinate with Process Development for tech transfers, and troubleshoot deviations related to GMP-compliant API manufacturing. Requirements: Master’s in Chemistry, Biochemistry, Chemical Engineering, or related field with 5+ years industry experience, or Bachelor’s with 8+ years; strong GMP knowledge, experience in drug substance manufacturing, data analysis, and technical documentation review. HighValue: biologics or oligonucleotide API manufacturing, early-phase development, cGMP compliance, external vendor oversight, troubleshooting batch deviations, and process monitoring. Collaboration: work closely with Analytical Development, Discovery, Regulatory, Quality, and Manufacturing teams. WorkSetup: not specified; candidates must have current work authorization.