Manager, cGMP Manufacturing

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

As Manager of cGMP Peptide Manufacturing, you will lead our peptide production operations during a critical growth phase. You will be responsible for executing and scaling solid-phase peptide synthesis (SPPS), downstream purification, lyophilization, and packaging operations across clinical and commercial campaigns at our Milpitas cGMP facility. This is a hands-on technical and leadership role reporting to the Head of Manufacturing, with direct authority over manufacturing operations, production staff, scheduling, and floor execution.

You will oversee day-to-day GMP production, in-process execution, campaign delivery, and operational excellence that ensure product quality, on-time delivery, and regulatory compliance. This role bridges peptide chemistry expertise with manufacturing operations, directly impacting batch success, CDMO customer confidence, and manufacturing efficiency.

Key Responsibilities

Site Operations

• Lead and mentor manufacturing team of 3-4 chemists, operators, and technicians; establish performance metrics, career development, technical training programs, and ensure high-throughput production operations

• Direct cGMP peptide production operations including SPPS, cleavage, prep HPLC purification, lyophilization, and final packaging across clinical and commercial campaigns

• Own production scheduling and on-time delivery; establish campaign plans, sequencing, and resource allocation across multiple concurrent programs to support manufacturing commitments

• Drive yield, throughput, and cost efficiency improvements; establish process performance targets based on capability analysis, historical data, and ICH guidance

• Ensure manufacturing operations comply with cGMP, internal SOPs, and master batch records per 21 CFR 210/211 and ICH Q7

• Manage production equipment (synthesizers, prep HPLC systems, lyophilizers, packaging lines); oversee equipment qualification, preventive maintenance, and vendor relationships

• Author and maintain master batch records, SOPs, and work instructions; establish justified process parameters based on process capability and development data

• Lead investigation of deviations, failed batches, and process excursions; conduct root cause analysis and implement corrective actions

• Support process characterization, scale-up, and tech transfer activities; partner with Process Development on new product introductions and PPQ campaigns

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

• Manage manufacturing execution systems (MES) and electronic batch records; drive digitalization of production operations

• Support CDMO customers with campaign execution, tech transfer, and manufacturing troubleshooting; maintain customer confidence through responsive operational support

System Optimization

• Support the design, implementation, and continuous improvement of core manufacturing 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 Support

• Support manufacturing audit and inspection follow-up, including drafting and driving effective responses, CAPAs, commitments, and remediation plans, and ensuring actions are completed on time and are operationally…