Manager, cGMP Manufacturing

4w4 weeks ago

CSBio

Milpitas, US · Full-time · $130,000 – $170,000

About this role

CSBio, founded in 1993, is a peptide contract manufacturer with a focus on cGMP production. As Manager of cGMP Peptide Manufacturing, you will lead peptide production operations during a critical growth phase, reporting to the Head of Manufacturing in a hands-on technical leadership role.

You will oversee day-to-day GMP production, including SPPS, purification, lyophilization, and packaging across clinical and commercial campaigns. This role bridges peptide chemistry expertise with manufacturing operations, directly impacting batch success, CDMO customer confidence, and manufacturing efficiency. You will own production scheduling and ensure on-time delivery.

You will lead and mentor a manufacturing team of 3-4 chemists, operators, and technicians, establishing performance metrics and technical training programs. The environment is a state-of-the-art cGMP facility in Milpitas, with a focus on operational excellence and regulatory compliance.

This role offers the opportunity to drive yield, throughput, and cost efficiency improvements while supporting process characterization and tech transfer. You will prepare manufacturing data packages for regulatory submissions and support CDMO customers, contributing to the company's expansion. You will also manage MES and electronic batch records to drive digitalization.

Requirements

Bachelor's degree in chemistry, biochemistry, or related field.
Experience in cGMP peptide manufacturing operations.
Knowledge of solid-phase peptide synthesis (SPPS), preparative HPLC, and lyophilization.
Leadership experience managing a team of manufacturing staff.
Understanding of cGMP regulations (21 CFR 210/211, ICH Q7).
Experience with deviation investigations and root cause analysis.
Familiarity with manufacturing execution systems (MES) and electronic batch records.

Responsibilities

Lead and mentor a manufacturing team of 3-4 chemists, operators, and technicians, establishing performance metrics and technical training programs.
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, establishing campaign plans and resource allocation across multiple concurrent programs.
Drive yield, throughput, and cost efficiency improvements using process capability analysis 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 including synthesizers, prep HPLC systems, lyophilizers, and packaging lines, overseeing qualification and maintenance.
Lead investigation of deviations and process excursions, conducting root cause analysis and implementing corrective actions.
Support CDMO customers with campaign execution, tech transfer, and manufacturing troubleshooting.

Benefits

Opportunity to work in a state-of-the-art cGMP facility dedicated to peptide production.
Hands-on leadership role with direct impact on company growth during a critical expansion phase.
Exposure to regulatory submissions (IND, CMC dossiers) and CDMO customer interactions.
Career development through technical training programs and performance metrics.
Work in a company with a successful FDA inspection history and commercial drug substance approval.