Manufacturing Process Specialist
PolyPeptide Group, San Diego, CA, United States
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr