Part-Time Process Validation Expert – Peptide Manufacturing

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

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.