Scientist , Early Phase Process Development
Listed on 2026-10-06
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Pharmaceutical
Pharmaceutical Manufacturing, Validation Engineer, Chemical Manufacturing, Quality Engineering
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.
High Value: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.
Work Setup:not specified; candidates must have current work authorization.
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