CSBio

Biotech

Manager,cGMPManufacturing

$135–185k ~AI est. Milpitas, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“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.

Biotech
Problems you'll solve

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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