Process Validation SME

Discover International; United States; On-site; USD 83,000 - 124,000; Part time

Job summary

Discover International seeks a Process Validation expert specialized in peptide manufacturing to lead PPQ efforts for a Phase III lead asset and guide in-house validation across the portfolio. The role is a focused, high-impact, part-time engagement reporting to the CMC team.

Responsibilities include validating processes, reviewing CDMO PPQs, and ensuring compliance with ICH/Q7 and FDA/EU guidance while supporting cross-functional stakeholders.

Qualifications

• Bachelor’s degree in chemistry, chemical engineering or related field; advanced degree preferred.
• Significant process validation experience in peptide manufacturing, including PPQ campaigns.
• Strong knowledge of peptide synthesis (solid/liquid phase) and purification.
• Experience authoring PPQ protocols, batch records and risk assessments.
• Familiarity with CQAs/CPPs and analytical method validation (ICH Q2) and ICH Q7/Q8-Q11.

Responsibilities

• Act as Process Validation SME for peptide drug substance manufacturing across lifecycle.
• Lead technical review of PPQ deliverables from CDMOs and compile final reports.
• Review batch records for compliance and alignment with control strategy.
• Author/review risk assessments (FMEA) supporting validation and control plan.
• Evaluate CQAs/CPPs and process characterization data with approved ranges.
• Ensure validation activities meet ICH Q7, Q8-Q11 and FDA/EU guidance.
• Review analytical method validation for drug substance release and in-process testing.
• Advise on peptide-specific validation topics: impurity fate, chromatography resin, lyophilization.
• Liaise with CDMOs to identify gaps and drive issue resolution.
• Provide validation input as in-house manufacturing scales up.
• Collaborate with Drug Substance, Quality, Analytical and Regulatory CMC teams.

Skills

Process validation

Peptide synthesis

PPQ campaigns

HPLC purification

Lyophilization

Analytical method validation

Risk assessments

CQAs/CPPs

Education

Bachelor's degree in chemistry or related

Advanced degree preferred

Job description

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.