Process Validation SME

About the opportunity

Our client is developing peptide therapies for endocrine and metabolic diseases. Their lead asset is in Phase III and is ready for process validation. The pipeline also includes earlier programs from preclinical through Phase I.

Manufacturing is held at leading peptide CDMOs, and the team is also building in-house capability for small-scale manufacturing. The client needs a Process Validation subject matter expert who knows peptide manufacturing in depth. This person will guide and review the PPQ effort for the lead asset and support the validation lifecycle across the portfolio.

The role suits a hands-on expert who wants a focused, high-impact part-time engagement. You would be a key technical partner to the CMC team as the lead program moves toward commercial readiness.

Key responsibilities

• Act as the Process Validation subject matter expert for peptide drug substance manufacturing across the lifecycle: process design, process performance qualification (PPQ) and continued process verification.
• Lead the technical review of PPQ deliverables from CDMOs, including protocols, executed batch records, data packages and the PPQ final report.
• Review executed and master batch records for completeness, compliance and consistency with the approved process and control strategy.
• Author, review and approve risk assessments (e.g., FMEA) that support process validation and the control strategy.
• Review the identification and justification of critical quality attributes (CQAs) and critical process parameters (CPPs), including process characterization data and proven acceptable ranges.
• Make sure validation activities and documentation meet ICH Q7, ICH Q8–Q11 and FDA and EU process validation expectations.
• Review analytical method validation for drug substance release and in-process testing, and confirm methods are validation-ready for PPQ.
• Advise on peptide-specific validation topics: impurity fate and purge, chromatography resin lifetime and reuse, intermediate hold times, lyophilization, and cleaning validation.
• Act as the client's technical voice with CDMO partners, raising gaps, deviations and risks and helping resolve them.
• Provide validation input as small-scale manufacturing moves in house from the CDMO.
• Work closely with internal Drug Substance, Quality, Analytical and Regulatory CMC stakeholders.

Qualifications

Required

• Bachelor's degree in chemistry, chemical engineering or a related scientific discipline; advanced degree preferred.
• Significant process validation experience in peptide manufacturing, including direct involvement in PPQ campaigns.
• Strong technical knowledge of peptide synthesis and purification: solid-phase and/or liquid-phase synthesis, cleavage, preparative HPLC purification and lyophilization.
• Experience authoring or reviewing PPQ protocols and final reports, batch records and validation risk assessments.
• Working knowledge of CQA and CPP assessment, control strategy development and analytical method validation (ICH Q2).
• Solid understanding of ICH Q7, ICH Q8–Q11 and FDA and EU process validation guidance.
• Able to work independently with minimal direction and deliver within a part-time, fractional schedule.

Preferred

• Experience at a peptide CDMO,
• Experience overseeing CDMOs from the sponsor side at a small or mid-size biotech.
• Late-stage or commercial-readiness experience, such as PPQ ahead of an NDA/BLA/MAA or contributing to CTD Module 3 process validation sections.
• Experience with long-acting or modified peptides (e.g., lipidated peptides or prodrugs) or GLP-1-class molecules.
• Experience supporting tech transfer or setting up in-house small-scale peptide manufacturing.