Production Chemist, CGMP Manufacturing
About The Position
The Production Chemist performs hands-on cGMP peptide manufacturing in either upstream operations (synthesis and cleavage) or downstream operations (preparative HPLC purification and lyophilization). The role carries out assigned batch tasks safely, accurately, and on schedule. Cross-training in the other manufacturing area may follow after the employee is established; prior experience in both areas is not required. Recent graduates are encouraged to apply, and training will be provided. The position is based at H&H Peptides in Menlo Park, California, and reports to the Supervisor, CGMP Manufacturing. The role executes manufacturing work according to approved batch records, SOPs, and work instructions; operates and cleans production equipment; prepares and labels solutions and buffers; conducts in-process checks; and documents work accurately and in real time. The chemist helps meet production schedules, communicates delays and constraints, promptly escalates unexpected results and deviations, and works with teammates, Quality, QC, and Maintenance to support process improvement and product quality. The position involves handling hazardous drugs, materials, solvents, and reagents, and requires wearing appropriate PPE while working with hazardous drugs. Medical approval is required to wear respiratory protection. The employee must be willing to acknowledge potential risks associated with handling certain hazardous drugs, including teratogenicity, carcinogenicity, and reproductive effects.
Requirements
- Bachelor’s degree in chemistry, biochemistry, chemical engineering, or a related discipline; recent graduates are welcome.
- Hands-on laboratory experience through coursework, internships, or work.
- Strong attention to detail and ability to follow procedures precisely and document accurately.
- Strong communication and time-management skills, with the ability to work independently and as part of a fast-moving team.
- Ability to stand for extended periods, lift up to 40 lbs., and wear required PPE.
- Ability to work Saturdays and/or Sundays as required by the production schedule.
- Ability to wear required PPE, including gloves, respiratory protection, and gowns when working with hazardous drugs.
- Medical approval to wear respiratory protection, including negative- or positive-pressure respirators such as N95, full-face respirator, SCBA, or PAPR.
- Willingness to confirm understanding of potential teratogenicity, carcinogenicity, and reproductive effects from handling certain hazardous drugs.
- Physical ability to walk up to 50% of the time, stand up to 100% of the time, squat and bend up to 20% of the time, and lift up to 80% of the time for shifts of up to twelve hours; must be able to lift up to 50 lbs.
Nice To Haves
- Background or hands-on experience in peptide synthesis (SPPS), through academic research, an internship, or industry (upstream).
- Experience with HPLC purification or lyophilization (downstream); experience in either area is sufficient.
- Familiarity with analytical HPLC and mass spectrometry for in-process data review.
- Prior exposure to cGMP or regulated environments.
Responsibilities
- Execute assigned manufacturing tasks according to approved batch records, SOPs, and work instructions, with minimal supervision and in a timely, efficient manner.
- Read and understand work orders, batch records, instructions, and final product specifications before starting tasks.
- Perform upstream SPPS and cleavage operations, including resin preparation, synthesizer operation, cleavage, precipitation, and crude peptide isolation.
- Verify protected amino acids batch by batch against specifications, including solubility and appearance, before use.
- Perform downstream preparative HPLC purification, fraction pooling, concentration, lyophilization, and final packaging.
- Check analytical HPLC and the mass of dissolved crude peptide, and identify target peptide peaks by integration and mass spectrometry to guide purification and fraction pooling.
- Safely handle raw materials, solvents, and reagents; operate and clean production equipment and instruments; and promptly report issues.
- Prepare and label chemical solutions and buffers according to standard formulas.
- Perform in-process checks and promptly escalate unexpected results.
- Complete assigned tasks on time to support batch and campaign schedules; communicate delays and material or equipment constraints to the Supervisor early and support shift hand-offs.
- Complete batch records, logbooks, standardized forms, purification records, and other process records accurately and in real time.
- Review data for accuracy and completeness before submission and perform data analysis as assigned.
- Promptly report deviations, keep the work area clean, organized, and inspection-ready, and complete GMP and safety training on time.
- Work closely with teammates, Quality, QC, and Maintenance, and participate in cross-training.
- Contribute observations and data that support process improvement and product quality.
Benefits
- Competitive salary.
- Comprehensive health benefits, including medical, dental, and vision.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
