Supervisor, cGMP Manufacturing

CSBio•Milpitas, CA

4d•Onsite

About The Position

CSBio is a peptide contract manufacturing company founded in 1993. The company has expanded its production capabilities significantly over the years, including adding cGMP clinical production capacity in Milpitas, CA in 2023. As Supervisor of cGMP Peptide Manufacturing, you will lead peptide production operations during a critical growth phase. This role involves executing and scaling solid-phase peptide synthesis (SPPS), downstream purification, lyophilization, and packaging operations for clinical and commercial campaigns. It is a hands-on technical and leadership position reporting to the Head of Manufacturing, with direct responsibility for manufacturing operations, staff, scheduling, and floor execution. The position focuses on overseeing daily GMP production, campaign delivery, and operational excellence to ensure product quality, on-time delivery, and regulatory compliance. This role combines peptide chemistry expertise with manufacturing operations to impact batch success, customer confidence, and efficiency.

Requirements

Bachelors Chemistry, Biochemistry, Chemical Engineering, or related discipline.
3+ 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.
1+ 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.

Nice To Haves

Experience with MES/eBR systems and continuous improvement initiatives is preferred.

Responsibilities

Lead and mentor a manufacturing team of 1-2 chemists, operators, and technicians, establishing performance metrics, career development, and technical training programs.
Direct cGMP peptide production operations including SPPS, cleavage, prep HPLC purification, lyophilization, and final packaging for clinical and commercial campaigns.
Own production scheduling and on-time delivery by establishing campaign plans, sequencing, and resource allocation for multiple concurrent programs.
Drive yield, throughput, and cost efficiency improvements by establishing process performance targets.
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), overseeing qualification, preventive maintenance, and vendor relationships.
Author and maintain master batch records, SOPs, and work instructions, establishing justified process parameters.
Lead investigations of deviations, failed batches, and process excursions, conducting root cause analysis and implementing corrective actions.
Support process characterization, scale-up, and tech transfer activities, partnering with Process Development on new product introductions and PPQ campaigns.
Prepare manufacturing data packages for regulatory submissions (IND, CMC dossiers) ensuring data integrity compliance (21 CFR Part 11, ALCOA+).
Manage manufacturing execution systems (MES) and electronic batch records, driving digitalization of production operations.
Support CDMO customers with campaign execution, tech transfer, and manufacturing troubleshooting.
Support the design, implementation, and continuous improvement of core manufacturing systems, ensuring compliance, practicality, and efficiency.
Support manufacturing audit and inspection follow-up, including drafting and driving effective responses, CAPAs, commitments, and remediation plans.
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.
Demonstrate willingness to roll up sleeves, dive into operational details, and help solve problems directly when needed.
Foster a culture of initiative, urgency, accountability, and continuous improvement within the manufacturing team.
Provide coaching and support to chemists to strengthen operational understanding, problem solving, and execution.

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 25
Basic 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