Associate Director, cGMP Manufacturing

CSBio • Milpitas, CA

1d • Onsite

About The Position

As Associate Director 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.

Requirements

• MS or PhD in Chemistry, Biochemistry, Chemical Engineering, or related discipline; or BS with 8+ years of cGMP peptide manufacturing experience
• 6+ years of cGMP manufacturing experience in pharmaceutical, biopharmaceutical, or peptide manufacturing
• 5+ years of 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.

Nice To Haves

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

Responsibilities

• Lead and mentor manufacturing team of 8-15 supervisors, operators, and technicians; establish performance metrics, career development, technical training programs, and ensure high-throughput production operations
• 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; establish campaign plans, sequencing, and resource allocation across multiple concurrent programs to support manufacturing commitments
• Oversee batch execution and floor operations; manage shift coverage, real-time troubleshooting, and ensure timely campaign progression from resin loading through final product
• Drive yield, throughput, and cost efficiency improvements; establish process performance targets based on capability analysis, historical data, 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 (synthesizers, prep HPLC systems, lyophilizers, packaging lines); oversee equipment qualification, preventive maintenance, and vendor relationships
• Author and maintain master batch records, SOPs, and work instructions; establish justified process parameters based on process capability and development data
• Lead investigation of deviations, failed batches, and process excursions; conduct root cause analysis and implement corrective actions
• Support process characterization, scale-up, and tech transfer activities; partner with Process Development on new product introductions and PPQ campaigns
• Prepare manufacturing data packages for regulatory submissions (IND, CMC dossiers); ensure data integrity compliance (21 CFR Part 11, ALCOA+)
• Manage manufacturing execution systems (MES) and electronic batch records; drive digitalization of production operations
• Support CDMO customers with campaign execution, tech transfer, and manufacturing troubleshooting; maintain customer confidence through responsive operational support
• Support the design, implementation, and continuous improvement of core manufacturing systems.
• Ensure systems are compliant, practical, efficient, and usable for front-line teams; identify opportunities to simplify workflows, reduce inefficiencies, and improve adoption.
• Serve as manufacturing subject matter expert during regulatory and client audits/inspections, representing production operations in front-room and back-room capacities.
• Develop sufficient operational depth across Manufacturing, Facilities, Validation, and related support functions, so that within approximately 6 months the individual can confidently represent and defend production operations in front of FDA, EU, clients, and other auditors without over-reliance on others.
• Lead manufacturing audit and inspection follow-up, including drafting and driving effective responses, CAPAs, commitments, and remediation plans, and ensuring actions are completed on time and are operationally practical and sustainable.
• 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; use firsthand operational knowledge to recommend practical solutions and realistic milestones.
• 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 supervisors and emerging leaders 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 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees