Production Process Specialist - Temporary
About The Position
PolyPeptide is seeking a Manufacturing Process Specialist to provide technical support for peptide manufacturing processes from technology transfer through commercial production. This role is ideal for someone who enjoys being close to the manufacturing floor, solving technical process challenges, and helping ensure processes are robust, compliant, and consistently executed. As a Manufacturing Process Specialist, you will support SPPS, cleavage, purification, and lyophilization operations while partnering with Manufacturing, Process Development, Quality Control, Quality Assurance, and external stakeholders. You will play an important role in technology transfer, equipment qualification, process validation, PPQ, CPV, investigations, and continuous improvement. Your work will directly support PolyPeptide’s commitment to quality, compliance, operational excellence, and reliable delivery to customers. Successful peptide manufacturing requires strong process understanding, clear documentation, and hands-on technical support. In this role, you will help bridge the gap between Process Development and Manufacturing by ensuring processes are transferred, scaled, qualified, monitored, and improved effectively. This is a strong opportunity for a technical professional who wants to make a visible impact on manufacturing performance, process robustness, and product quality in a cGMP environment.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related field
- Minimum of 3 years of experience in pharmaceutical manufacturing or a cGMP environment
- Strong understanding of cGMP manufacturing principles
- Working knowledge of equipment qualification, including IQ, OQ, and PQ
- Hands-on experience supporting process validation activities, including PPQ execution and CPV
- Familiarity with cleaning validation principles, residue risk assessment, and contamination control
- Experience authoring or reviewing GMP documentation
- Strong understanding of quality systems, including deviations, investigations, CAPAs, and change controls
- Process troubleshooting and technical problem solving
- Root cause analysis and data-driven decision making
- cGMP manufacturing knowledge
- Technology transfer support
- Process validation and equipment qualification
- PPQ and CPV support
- GMP documentation accuracy
- Cross-functional collaboration
- Clear verbal and written communication
- Client-facing and audit communication confidence
- Proactive, floor-focused technical support
Nice To Haves
- Peptide manufacturing experience preferred
- Technical knowledge of SPPS, cleavage, purification, and lyophilization preferred
Responsibilities
- Provide floor-side technical support during peptide manufacturing operations, including SPPS, cleavage, purification, and lyophilization
- Investigate and troubleshoot critical manufacturing issues
- Contribute technical expertise to deviation investigations, root cause analysis, and CAPA implementation
- Lead or support technology transfers between Process Development and Manufacturing, as well as across manufacturing sites
- Ensure transferred processes are well understood, reproducible, and supported by complete documentation
- Support Process Performance Qualification, PPQ, activities, including protocol drafting, execution support, data collection, data review, and reporting
- Support Continued Process Verification, CPV, through process monitoring, trend analysis, and identification of potential process variability
- Introduce and qualify new manufacturing equipment
- Draft and execute IQ, OQ, and PQ protocols and prepare associated GMP documentation
- Standardize and improve manufacturing workflows and batch documentation
- Help reduce human error, improve data integrity, and increase operational consistency
- Collaborate cross-functionally with Manufacturing, Process Development, Quality Control, and Quality Assurance
- Support routine operations, investigations, and new production introductions
- Serve as a technical subject matter expert for process-related topics with clients, regulatory teams, and internal stakeholders
Benefits
- Equal opportunity employer
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What This Job Offers
Career Level
Mid Level
