Manufacturing Process Specialist
About The Position
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 .
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Engineering, or related field
- 3+ years of experience in pharmaceutical manufacturing or cGMP environment
- 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
Nice To Haves
- Peptide manufacturing experience preferred
- 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
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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
