Associate Director, Quality Control

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 Director of Quality Control, you will lead our QC laboratory operations and analytical chemistry function during a critical growth phase. You will be responsible for establishing and scaling world-class analytical testing, method validation, and release testing protocols for our cGMP peptide manufacturing facility. This is a hands-on technical and leadership role reporting to the VP of Operations, with direct authority over QC operations, analytical method development, laboratory staff, and testing strategy.

You will oversee in-process controls, final product release testing, stability studies, and analytical chemistry excellence that ensure product quality and regulatory compliance. This role bridges chemistry expertise with manufacturing operations, directly impacting batch release, CDMO customer confidence, and manufacturing efficiency.

Key Responsibilities

Site Operations

•       Lead and mentor QC laboratory team of 5-8 analysts and chemists; establish performance metrics, career development, technical training programs, and ensure high-throughput testing operations

•       Develop, validate, and implement analytical methods for peptide characterization including HPLC, LC-MS/MS, mass spectrometry, amino acid analysis, and peptide sequencing

•       Manage in-process controls (IPC) strategy; establish sampling plans, acceptance criteria, and real-time testing to support manufacturing decisions

•       Oversee final product release testing; manage batch record reviews, generate release reports, and ensure timely product disposition (release, reject, rework)

•       Design and execute stability studies (ICH Q1A/Q1B); manage sample collection, analytical testing schedules, and data integrity for regulatory submissions

•       Ensure analytical method validation per ICH Q2(R2); conduct validation studies, manage validation protocols, statistical analysis, and prepare validation reports

•       Manage lab equipment (HPLC, LC-MS, mass spec, thermal analysis); oversee instrument qualification, preventive maintenance, and vendor relationships

•       Develop and maintain analytical specifications; establish justified specification ranges based on process capability, ICH guidance, and historical data

•       Lead investigation of out-of-specification results and failed batches; conduct root cause analysis and implement corrective actions

•       Support process characterization and scale-up activities; develop analytical strategies for new products and manufacturing processes

•       Prepare testing data packages for regulatory submissions (IND, CMC dossiers); ensure data integrity compliance (21 CFR Part 11, ALCOA+)

•       Manage laboratory information management systems (LIMS) and electronic batch records; drive digitalization of QC operations

•       Support CDMO customers with testing, method transfer, and analytical troubleshooting; maintain customer confidence through responsive QC support

System Optimization

·       Support the design, implementation, and continuous improvement of core quality 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 Lead

·       Lead and independently host regulatory and client audits/inspections, serving as the primary quality representative and front-room lead for assigned audits and inspections.

·       Develop sufficient operational subject matter expertise across key areas beyond Quality, including Manufacturing, Facilities, Validation, and related support functions, so that within approximately 6 months the individual can confidently represent and defend these operations in front of FDA, EU, clients, and other auditors without over-reliance on others.

·       Lead 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 QA and QC teams; ensure issues are surfaced early, discussed openly, and resolved with practical, sustainable solutions.

·       Provide coaching and support to team members 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 quality operations leader now and grow into broader Director of Quality responsibilities over time. Progression will depend on demonstrated ability to lead QA and QC operations with increasing independence, translate operational knowledge into practical quality 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.

Requirements

• •       PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline; or MS with 8+ years QC/analytical chemistry experience
• •       12+ years of analytical chemistry and QC experience in pharmaceutical, biopharmaceutical, or chemical manufacturing
• •       5+ years of hands-on experience with HPLC, LC-MS, and advanced analytical instrumentation
• •       3+ years in a leadership role managing QC laboratories or analytical teams
• •       Expertise in analytical method validation (ICH Q2(R2)), release testing, and cGMP batch testing
• •       Strong understanding of FDA cGMP expectations for QC operations, data integrity (21 CFR Part 11), and test method documentation
• •       Experience writing and executing analytical method validation protocols and final validation reports
• •       Demonstrated laboratory management skills including budget oversight, vendor management, and staffing
• •       Strong problem-solving and investigative skills; ability to troubleshoot analytical and testing issues
• •       Excellent communication skills; ability to communicate test results and specifications clearly to manufacturing, operations, and regulatory teams
• Demonstrated ability to work effectively in a small, hands-on, fast-moving organization.
• Experience with eQMS/LIMS 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