Chemist, Quality Control

CSBio; Menlo Park (CA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k 10% match

PTO 10 days

Company paid holidays

Disability insurance

Transportation and cell phone stipend

Employee recognition program

Team building activities

Job summary

CSBio, a peptide contract manufacturing company, seeks a QC Chemist in California to perform analytical testing in a GMP-regulated laboratory. You will execute validated methods, maintain documentation, and support method qualification and laboratory improvements.

Responsibilities include operating HPLC/UPLC, GC, Karl Fischer, and elemental analysis instruments, ensuring data integrity, and contributing to investigations and continuous improvement efforts within the QC team.

Qualifications

• Bachelor’s degree in Chemistry or related field.
• Typically 2+ years in GMP pharma/biotech/cctl lab environment.
• Hands-on experience with HPLC/UPLC, GC, Karl Fischer, elemental analysis.
• Familiarity with cGMP/GLP documentation practices and SOPs.

Responsibilities

• Perform QC testing for raw material, in-process, finished product, API, and stability programs.
• Operate analytical instrumentation (HPLC/UPLC, GC, Karl Fischer, elemental analysis) and review data for accuracy.
• Prepare and review test records, notebooks, logs, and controlled documents.
• Assist in method qualification, validation, and transfer activities.
• Support investigations, deviations, and maintain lab readiness and cleanliness.

Skills

Laboratory testing

Documentation

Report writing

QA understanding

Education

Bachelor’s degree in Chemistry

Tools

HPLC/UPLC

GC

Karl Fischer

Elemental analysis

Microsoft Word

Microsoft Excel

PowerPoint

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