What are the responsibilities and job description for the Manufacturing Process Specialist position at PolyPeptide Group?
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
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.
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
- Bachelor’s degree in Chemistry, Biochemistry, Engineering, or related field
- 3 years of experience in pharmaceutical manufacturing or cGMP environment
- Peptide manufacturing experience preferred
- 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
- 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
- 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
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.
Salary : $33 - $37