Manager, Cgmp Manufacturing
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Overview
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
System Optimization
Audit/Inspection Support
Hands-On Leadership
Model CSBio's expectation that leaders understand operations at a task level; to observe workflows, understand bottlenecks, and identify where quality or execution is breaking down.Team Development
Foster a culture of initiative, urgency, accountability, and continuous improvement within the manufacturing team; ensure issues are surfaced early, discussed openly, and resolved with practical, sustainable solutions.Provide coaching and support to chemists to strengthen operational understanding, problem solving, and execution.Competencies:
To perform the job successfully, an individual should demonstrate the following competencies:
Problem Solving- Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
Teamwork- Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Supports everyone's efforts to succeed.
Organizational Support- Follows policies and procedures; Completes tasks correctly and on time; Supports organization goals and values.
Motivation- Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence.
Adaptability- Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Requirements
- Bachelors Chemistry, Biochemistry, Chemical Engineering, or related discipline.
- 6+ years of cGMP manufacturing experience in pharmaceutical, biopharmaceutical, or peptide manufacturing
- Hands-on experience with solid-phase peptide synthesis (SPPS), prep HPLC purification, and lyophilization unit operations
- 3+ years in a leadership role managing manufacturing operations or production teams
- Expertise in cGMP batch execution, master batch record authoring, and campaign management
- Strong understanding of FDA cGMP expectations for manufacturing operations, data integrity (21 CFR Part 11), and batch record documentation
- Experience supporting process validation, PPQ campaigns, and tech transfer of new peptide products into GMP manufacturing
- Demonstrated manufacturing management skills including budget oversight, capital project management, vendor management, and staffing
- Strong problem-solving and investigative skills; ability to troubleshoot process and equipment issues in real time on the manufacturing floor
- Excellent communication skills; ability to communicate manufacturing status, deviations, and risks clearly to quality, operations, and regulatory teams
- Demonstrated ability to work effectively in a small, hands-on, fast-moving organization.
- Experience with MES/eBR systems and continuous improvement initiatives is preferred.
Benefits
- Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
- 401k 10% 1:1 match
- PTO policy. 10 days PTO
- Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
- Disability insurance 50% standard employer paid.
- Carpool, clean air vehicle, and cell phone reimbursement
- Employee rewards and recognition program
- Company organized social events
- Quarterly sponsored team building activities
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