Manufacturing Process Specialist

Location: San Diego, CA | Employment Type: Full-TimeBe 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 SummaryThe 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 ResponsibilitiesProvide hands-on support for SPPS, Cleavage, Purification, and Lyophilization processesLead and support deviation investigations, root cause analysis, and CAPADrive technology transfers between Development and ManufacturingSupport PPQ execution and CPV monitoring, including data analysis and reportingLead equipment qualification (IQ/OQ/PQ) and introduce new manufacturing systemsImprove batch documentation and workflows to enhance efficiency and data integrityCollaborate cross-functionally with MFG, PD, QC, and QAServe as a technical SME for internal teams and external stakeholdersQualificationsBachelor’s degree in Chemistry, Biochemistry, Engineering, or related field3+ years of experience in pharmaceutical manufacturing or cGMP environmentPeptide manufacturing experience preferredTechnical StrengthsKnowledge of cGMP manufacturing, process validation, and equipment qualificationExperience with SPPS, purification, and lyophilization processesStrong background in GMP documentation, investigations, and change controlWhat Sets You ApartStrong problem-solving and analytical mindsetAbility to work hands-on in manufacturing environmentsClear communication across technical and non-technical teamsCollaborative approach with confidence in client-facing situationsWhy Join PolyPeptideWork at a global leader in peptide manufacturingGain exposure across development, manufacturing, and validationPlay a key role in scaling processes for commercial productionCollaborate with experienced teams in a fast-paced, technical environmentIf 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/hrWe 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.