Production Chemist, CGMP Manufacturing

About The Role

The Production Chemist performs hands-on cGMP peptide manufacturing, supporting either upstream operations (synthesis and cleavage) or downstream operations (preparative HPLC purification and lyophilization). You will carry out assigned batch tasks safely, accurately, and on schedule. Cross-training in the other area may follow once established in the role. Experience in both areas is not required; strength in either one is enough. This role reports to the Supervisor, CGMP Manufacturing and is based in Menlo Park, CA. Recent graduates are encouraged to apply; training will be provided.

Key Responsibilities

• Execute assigned manufacturing tasks per approved batch records, SOPs, and work instructions with minimal supervision, in a timely and efficient manner.
• Read work orders and batch records thoroughly and understand the instructions and final product specifications before starting each task.
• Upstream: Perform SPPS and cleavage operations, including resin preparation, synthesizer operation, cleavage, precipitation, and crude peptide isolation.
• Upstream: Verify protected amino acids batch by batch against specification, including solubility and appearance, before use.
• Downstream: Perform prep HPLC purification, fraction pooling, concentration, lyophilization, and final packaging.
• Downstream: Check analytical HPLC and mass of dissolved crude peptide and identify the target peptide peak by integration and mass spectrometry to guide purification and fraction pooling.
• Handle raw materials, solvents, and reagents safely.
• Operate and clean production equipment and instruments including HPLCs, centrifuges, freeze dryers, stir plates, laboratory balances, mass spectrometers (optional), sonicators, vacuum ovens, and nitrogen supply. Report issues promptly.
• Prepare and label chemical solutions and buffers according to standard formulas.
• Perform in-process checks and escalate unexpected results immediately.
• Complete assigned tasks on time to support batch and campaign schedules.
• Communicate delays or material and equipment constraints to the Supervisor early and support shift hand-offs.
• Complete batch records, logbooks, and standardized forms accurately and in real time, including purification and other process records.
• Review data for accuracy and completeness before submission and perform data analysis as assigned.
• Report deviations promptly, keep the work area clean, organized, and inspection-ready.
• Complete GMP and safety training on time.
• Work closely with teammates, Quality, QC, and Maintenance.
• Take part in cross-training.
• Contribute observations and data that support process improvement and product quality.

Requirements & Tech Stack

• cGMP manufacturing environment
• SPPS
• Cleavage operations
• HPLC purification
• Lyophilization
• Analytical HPLC
• Mass Spectrometry (optional)
• HPLCs
• Freeze dryers
• Laboratory balances
• Sonicators
• Vacuum ovens
• Nitrogen supply

Qualifications

• Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, or a related discipline.
• Hands-on laboratory experience, through coursework, internships, or work.
• Strong attention to detail and the ability to follow procedures precisely and document accurately.
• Strong communication and time management skills.
• 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.

Preferred Qualifications

• Background or hands-on experience in peptide synthesis (SPPS).
• Experience with HPLC purification or lyophilization.
• Familiarity with analytical HPLC and mass spectrometry for in-process data review.
• Prior exposure to cGMP or regulated environments.

Conditions Of Employment

• This position will require working with Hazardous Drugs (HD) and require Personal Protective Equipment (PPE) to be worn.
• Medical approval required to wear respiratory protection.
• Physical exertion required, including walking up to 50%, standing up to 100%, squatting and bending up to 20%, and lifting up to 80% for up to a twelve-hour shift. Must be able to lift up to 50 lbs.
• Associates must be willing to confirm understanding of potential risks associated with handling Hazardous Drugs (HD).