Manager, Quality Control

Manager Of 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 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.

As Manager of Quality Control, you will lead our QC laboratory operations and analytical chemistry function during a critical growth phase. You will be responsible for establishing and scaling world-class analytical testing, method validation, and release testing protocols for our cGMP peptide manufacturing facility. This is a hands-on technical and leadership role reporting to the VP of Operations, with direct authority over QC operations, analytical method development, laboratory staff, and testing strategy.

You will oversee in-process controls, final product release testing, stability studies, and analytical chemistry excellence that ensure product quality and regulatory compliance. This role bridges chemistry expertise with manufacturing operations, directly impacting batch release, CDMO customer confidence, and manufacturing efficiency.

Site Operations

• Lead and mentor QC laboratory team of 5-8 analysts and chemists; establish performance metrics, career development, technical training programs, and ensure high-throughput testing operations

• Develop, validate, and implement analytical methods for peptide characterization including HPLC, LC-MS/MS, mass spectrometry, amino acid analysis, and peptide sequencing

• Manage in-process controls (IPC) strategy; establish sampling plans, acceptance criteria, and real-time testing to support manufacturing decisions

• Oversee final product release testing; manage batch record reviews, generate release reports, and ensure timely product disposition (release, reject, rework)

• Design and execute stability studies (ICH Q1A/Q1B); manage sample collection, analytical testing schedules, and data integrity for regulatory submissions

• Ensure analytical method validation per ICH Q2(R2); conduct validation studies, manage validation protocols, statistical analysis, and prepare validation reports

• Manage lab equipment (HPLC, LC-MS, mass spec, thermal analysis); oversee instrument qualification, preventive maintenance, and vendor relationships

• Develop and maintain analytical specifications; establish justified specification ranges based on process capability, ICH guidance, and historical data

• Lead investigation of out-of-specification results and failed batches; conduct root cause analysis and implement corrective actions

• Support process characterization and scale-up activities; develop analytical strategies for new products and manufacturing processes

• Prepare testing data packages for regulatory submissions (IND, CMC dossiers); ensure data integrity compliance (21 CFR Part 11, ALCOA+)

• Manage laboratory information management systems (LIMS) and electronic batch records; drive digitalization of QC operations

• Support CDMO customers with testing, method transfer, and analytical troubleshooting; maintain customer confidence through responsive QC support

System Optimization

· Support the design, implementation, and continuous improvement of core quality systems.

· Ensure systems are compliant, practical, efficient, and usable for front-line teams; identify opportunities to simplify workflows, reduce inefficiencies, and improve adoption.

Audit/Inspection Lead

· Lead and independently host regulatory and client audits/inspections, serving as the primary quality representative and front-room lead for assigned audits and inspections.

· Develop sufficient operational subject matter…