Associate Director, cGMP Manufacturing at CSBio

Milpitas, California, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Aug, 26

Salary

0.0

Posted On

13 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Manufacturing, Solid-Phase Peptide Synthesis, Prep HPLC Purification, Lyophilization, Production Scheduling, Root Cause Analysis, Tech Transfer, Regulatory Compliance, Batch Record Authoring, Team Leadership, Process Validation, Equipment Qualification, CAPA, Data Integrity, MES, Budget Oversight

Industry

Biotechnology Research

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 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. Key Responsibilities Site Operations • 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 System Optimization • 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. Audit/Inspection Support • 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. 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. • 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. 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 supervisors and emerging leaders to strengthen operational understanding, problem solving, and execution. Growth Path This role is intended for someone who can operate as a strong manufacturing operations leader now and grow into broader Director of Manufacturing responsibilities over time. Progression will depend on demonstrated ability to lead production operations with increasing independence, translate operational knowledge into practical manufacturing goals and milestones, shape and improve systems that fit CSBio's business model, support and eventually lead audits and inspections with confidence, and develop team capability across functions. 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. 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. Experience with MES/eBR systems and continuous improvement initiatives is preferred. 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

Responsibilities

Lead and scale cGMP peptide production operations, including synthesis, purification, and packaging at the Milpitas facility. Manage production staff, ensure regulatory compliance with FDA and ICH guidelines, and oversee campaign delivery for clinical and commercial projects.