Manufacturing Process Specialist

Location: San Diego, CA | Employment Type: Full-Time

Be the technical expert behind high-impact peptide manufacturing.

PolyPeptide is a global leader in peptide development and manufacturing, supporting some of the most advanced therapies in the industry. We are looking for a Manufacturing Process Specialist to bridge process development and manufacturing, ensuring our processes are robust, scalable, and consistently deliver high-quality results.

If you enjoy solving complex problems, working hands-on in a GMP environment, and driving process improvements, this role offers strong technical exposure and growth.

Position Summary

The Manufacturing Process Specialist provides floor-side technical support and drives process excellence across peptide manufacturing operations. You will play a key role in technology transfer, process validation (PPQ/CPV), equipment qualification, and investigations, helping ensure reliable and compliant production from development through commercial manufacturing.

Key Responsibilities

• Provide hands-on support for SPPS, Cleavage, Purification, and Lyophilization processes

• Lead and support deviation investigations, root cause analysis, and CAPA

• Drive technology transfers between Development and Manufacturing

• Support PPQ execution and CPV monitoring, including data analysis and reporting

• Lead equipment qualification (IQ/OQ/PQ) and introduce new manufacturing systems

• Improve batch documentation and workflows to enhance efficiency and data integrity

• Collaborate cross-functionally with MFG, PD, QC, and QA

• Serve as a technical SME for internal teams and external stakeholders

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or related field

• 3+ years of experience in pharmaceutical manufacturing or cGMP environment

• Peptide manufacturing experience preferred

Technical Strengths

• Knowledge of cGMP manufacturing, process validation, and equipment qualification

• Experience with SPPS, purification, and lyophilization processes

• Strong background in GMP documentation, investigations, and change control

What Sets You Apart

• Strong problem-solving and analytical mindset

• Ability to work hands-on in manufacturing environments

• Clear communication across technical and non-technical teams

• Collaborative approach with confidence in client-facing situations

Why Join PolyPeptide

• Work at a global leader in peptide manufacturing

• Gain exposure across development, manufacturing, and validation

• Play a key role in scaling processes for commercial production

• Collaborate with experienced teams in a fast-paced, technical environment

If you are a driven technical professional looking to make a direct impact on manufacturing performance and product quality, we encourage you to apply.

Salary: $33-$37/hr

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.