CSBio
Biotech
Manager,cGMPManufacturing
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“Manager, cGMP Manufacturing at CSBio. Skills: CGMP Manufacturing, Peptide Synthesis, Production Operations, Team Leadership. Lead manufacturing team. Establish performance metrics”
What You'll Achieve.
Ensure product quality; Ensure on-time delivery; Ensure regulatory compliance; Improve adoption
Industry & Context.
Troubleshoot process issues; Troubleshoot equipment issues; Root cause analysis
What They're Looking For.
Must Have
Bachelors Chemistry or related discipline, 6+ years cGMP manufacturing experience, Hands-on SPPS experience, Hands-on prep HPLC purification experience, Hands-on lyophilization experience, 3+ years leadership role, Expertise in cGMP batch execution, Master batch record authoring expertise, Campaign management expertise, Understanding FDA cGMP expectations, Experience supporting process validation, Experience supporting PPQ campaigns, Experience supporting tech transfer, Demonstrated manufacturing management skills, Problem-solving ability, Investigative ability, Excellent communication ability
Nice to Have
Experience with MES/eBR systems, Experience with continuous improvement initiatives
What You'll Do.
Lead manufacturing team
Establish performance metrics
Establish career development
Establish technical training
Ensure high-throughput production
Direct cGMP peptide production
Own production scheduling
Establish campaign plans
Establish resource allocation
Drive yield efficiency
Drive throughput efficiency
Drive cost efficiency
Establish process performance targets
Ensure manufacturing operations comply
Manage production equipment
Oversee equipment qualification
Oversee preventive maintenance
Author master batch records
Maintain master batch records
Author work instructions
Maintain work instructions
Establish justified process parameters
Lead investigation of deviations
Lead investigation of failed batches
Lead investigation of process issues
Conduct root cause analysis
Implement corrective actions
Support process characterization
Support tech transfer
Partner with Process Development
Prepare manufacturing data packages
Ensure data integrity compliance
Manage manufacturing execution systems
Manage electronic batch records
Drive digitalization of production
Support CDMO customers
Maintain customer confidence
How You'll Work.
Team & Collaboration
Cross-functional teams; Quality teams; Operations teams; Regulatory teams; CDMO customers
Communication Scope
Manufacturing status; Deviations; Risks
Process & Methodology
Campaign management, Process validation, PPQ campaigns, Tech transfer
Full Job Description
### 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 operatio
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