Chemist, Quality Control

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 1994 we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies 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 2017 we passed a FDA inspection and were recommended to be approved for commercial drug substance 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.

Qualifications

• Bachelors 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.

• Medical dental and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employees 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 ($20000 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

Required Experience:

IC