Production Chemist - San Diego
About The Position
PolyPeptide is hiring Production Chemists at Levels I, II, and III to support the manufacture of high-quality Active Pharmaceutical Ingredients (APIs) in a cGMP-regulated environment. The role supports production of safe, effective, and on-time pharmaceutical products and provides hands-on experience with peptide synthesis and purification technologies. Production Chemists execute and support peptide manufacturing operations across upstream synthesis and downstream purification while maintaining cGMP, safety, and quality standards. Chemist I works under general supervision, focusing on production execution and developing technical expertise. Chemist II works with increasing autonomy, troubleshoots deviations, supports investigations and CAPAs, mentors Chemist I staff, and contributes to process improvements, tech transfers, and scale-up. Chemist III serves as a technical leader and subject matter expert, makes operational go/no-go decisions in partnership with Quality and leadership, leads troubleshooting and process optimization, mentors Chemist I and II staff, and supports production planning, forecasting, and continuous improvement. The work takes place in a hands-on manufacturing environment involving hazardous materials. The position requires wearing respirators and other required PPE, and involves regular standing, walking, and lifting up to 25 pounds.
Requirements
- Bachelor’s degree in a scientific discipline or equivalent; a high school diploma with significant GMP manufacturing experience may be considered for Chemist I.
- Chemist I: 0–2 years of relevant experience; peptide manufacturing is preferred.
- Chemist II: 3 or more years of relevant experience in a regulated environment.
- Chemist III: 5 or more years of relevant experience with demonstrated leadership and technical expertise.
- Knowledge of peptide synthesis and purification, including HPLC.
- Knowledge of cGMP documentation and compliance.
- Ability to safely handle hazardous chemicals and reagents.
- Strong communication, teamwork, and time-management skills.
- Problem-solving ability and a continuous-improvement mindset.
- Ability to wear respirators and required PPE.
- Ability to stand and walk regularly and lift up to 25 pounds.
Nice To Haves
- Peptide manufacturing experience is preferred for Chemist I.
Responsibilities
- Execute batch production records accurately and in compliance with SOPs and GxP requirements.
- Operate and monitor chemical processes and equipment, including reactors, drying systems, purification HPLCs, and lyophilization.
- Perform in-process controls (IPCs) and interpret analytical results, including HPLC and ninhydrin tests.
- Handle materials properly, manage inventory, and document work in the ERP system according to ALCOA+ principles.
- Maintain safety, cleanliness, PPE usage, and 5S practices.
- Communicate with cross-functional teams, including QA, QC, Maintenance, Engineering, and Supply Chain.
- At Chemist II level, troubleshoot process deviations, support investigations, and assist with CAPAs and quality documentation.
- At Chemist II level, train and mentor Chemist I team members and participate in process improvements, tech transfers, and scale-up activities.
- At Chemist III level, act as a subject matter expert for processes and equipment and make operational go/no-go decisions with Quality and leadership.
- At Chemist III level, lead troubleshooting, process optimization, and mentoring of Chemist I and II staff.
- At Chemist III level, support production planning, forecasting, and continuous improvement initiatives.
Benefits
- Clear growth paths
- Hands-on manufacturing experience
- Opportunity to develop expertise alongside experienced scientists
- Collaborative, safety-first manufacturing environment
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
