Chemist, Quality Control

Job Description

Job Description

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

Position Summary

The QC Chemist is responsible for performing chemical and analytical testing to support raw material, in-process, release, and stability programs in a GMP-regulated environment. This role executes compendial, validated, and approved internal test methods; ensures laboratory activities are documented in accordance with internal quality standards, cGMP requirements, and applicable regulatory expectations; and supports method qualification, laboratory investigations, equipment maintenance, and continuous improvement of QC laboratory systems.

Key Responsibilities

Laboratory Testing

·       Perform QC testing in support of raw material, in-process, finished product, API, and stability testing using approved methods, specifications, and procedures.

·       Operate analytical instrumentation, including HPLC/UPLC, GC, Karl Fischer, and elemental analysis equipment, and perform routine data review to ensure results are accurate, complete, and compliant.

Documentation and Compliance

·       Complete test records, laboratory notebooks, logbooks, worksheets, and controlled forms accurately and contemporaneously in compliance with internal quality standards, cGMP requirements, and applicable regulations.

·       Review analytical data for completeness, accuracy, and adherence to approved methods and good documentation practices.

Method Support

·       Assist in method qualification and related activities, including feasibility testing, protocol execution, data compilation, and preparation or revision of qualification and validation reports as required.

·       Support transfer, implementation, and continuous improvement of analytical methods used in the QC laboratory.

SOP and Document Management

·       Prepare, review, and revise QC-related SOPs, specifications, test methods, forms, and other controlled documents as needed to support compliant laboratory operations.

Equipment Maintenance

·       Perform in-house calibration, routine verification, troubleshooting, and preventive maintenance of laboratory instruments and equipment according to approved procedures and schedules.

Investigations and Lab Support

·       Assist with laboratory events, deviations, out-of-specification or out-of-trend results, and other laboratory investigations to support timely resolution and appropriate documentation.

·       Maintain a clean, organized, and inspection-ready laboratory environment and perform other related duties as required by the company.

Requirements

Qualifications

• Bachelor’s degree in Chemistry or a related scientific discipline.
• Typically 2+ years of relevant experience, ideally in a GMP pharmaceutical, biotech, or contract testing laboratory environment.
• Hands-on experience with analytical instrumentation including HPLC/UPLC, GC, Karl Fischer, and elemental analysis.
• Working knowledge of cGMP and GLP documentation practices preferred.
• Experience writing or contributing to reports, SOPs, protocols, and technical documents.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Knowledge of chemical synthesis processes and API manufacturing is preferred but not required.

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities