Description
CPC Scientific (CPC) is a globally recognized and leading CDMO specializing in synthetic peptide and oligonucleotide production, with one of the largest research peptide facilities in the world. CPC works directly with leaders in the biotechnology and pharmaceutical industries to bring life-changing therapeutics and diagnostics to market ranging from early drug discovery stages through clinical trials to commercial manufacturing.
CPC is seeking a Director of Quality Control (QC) to fill a full-time, on-site role in our Rocklin, California facility. This position will report directly to either the CEO or QA Director and is responsible for overseeing full lifecycle planning, greenfield construction and daily operation of the QC laboratory in the new peptide CDMO facility while delivering lab compliance and technical excellence.
The person in this role will establish comprehensive laboratory QC framework fully aligned with FDA 21 CFR Part 210/211, ICH Guidelines, EU GMP, USP & EP. Manage full testing workflow for raw materials, intermediates, finished goods, cleaning validation and stability samples, full lifecycle of analytical methods, instrument asset management, closed-loop handling of lab OOS/OOT/deviations/CAPAs. Lead all QC-related activities during FDA, client and third-party audits. Build and manage the QC team, department budget and lab EHS governance. In addition, provide end-to-end QC support for commercial peptide synthesis, purification, fill-finish, technology transfer and process validation. Will also, strictly enforce ALCOA+ data integrity, enable smooth site commissioning in Q4 2026, sustain permanent inspection readiness, and deliver compliant testing and Certificates of Analysis consistently.
This position will interact with all levels within the organization. Professionalism and maintaining confidentiality are an integral part of the job.
DUTIES:
Quality Control Leadership & Strategy
Develop medium to long term lab strategy, annual department objectives and operational plans tailored to peptide CDMO business, aligning with site commercial schedules and global client delivery commitments;
Act as senior QC representative in site leadership meetings and executive client communications, submit lab KPI and critical technical risk reports;
Foster lab culture centered on scientific rigor, compliance accountability and continuous improvement, embed data integrity mindset among all lab staff;
Oversee pre-construction lab layout design, resource allocation, staffing plan, annual budget formulation and cost optimization.
Laboratory Operations & Regulatory Compliance
Ensure 100% compliance of all lab activities with FDA 21 CFR, ICH, EU GMP, USP/EP, cGMP, GDP and ALCOA+ data integrity principles;
Maintain permanent FDA inspection readiness, coordinate all QC audit documentation, on-site walkthrough and observation remediation tracking;
Establish and continuously update full suite of lab SOPs, specifications, sampling protocols, instrument SOPs and record templates;
Monitor global pharmacopoeia and regulatory updates, deliver site-wide lab regulatory training and align internal systems timely;
Implement full lab EHS control covering reagents, reference standards, hazardous waste, gas cylinders and cleanroom PPE requirements.
Analytical Testing & Laboratory Oversight
Oversee sampling and full testing for raw materials, packaging, intermediates, peptide DS/DP, cleaning validation, environmental, purified water and stability samples;
Control testing turnaround time to deliver accurate, efficient analytical data and timely release with official CoA issuance;
Own full lifecycle management of analytical methods including development, transfer, qualification, validation and annual review;
Govern IQ/OQ/PQ, periodic calibration and preventive maintenance for HPLC, MS, microbial and all lab instrumentation;
Review and approve all raw analytical data, lab reports, validation protocols/reports, specifications and batch test records.
Laboratory Investigations & Quality Systems
Lead all OOS, OOT, atypical result and lab deviation investigations, conduct scientific root cause analysis, develop CAPAs and track full closure;
Review full change control workflows related to lab equipment, software, analytical methods and sampling procedures;
Govern all paper and electronic raw records to ensure contemporaneous recording and full traceability with strict data integrity enforcement;
Provide complete analytical data and technical input to QA to support batch release decisions;
Manage reference standards, retention sample library and full stability study programs, ensure sufficient sample volume and compliant storage conditions.
Peptide Manufacturing & CDMO Support
Deliver full QC technical support for commercial peptide synthesis, purification, fill-finish and packaging workflows;
Participate in analytical design and execution for technology transfer, process validation and cleaning validation;
Serve primary QC liaison for global CDMO clients, address analytical requests, technical discussions, audit coordination and regulatory filing data provision;
Collaborate with Manufacturing, Process Dev, QA and Supply Chain to meet production timelines and client project milestones;
Support supplier audits and conduct qualification assessments for reagents, reference standards and third-party testing vendors.
Continuous Improvement & Team Leadership & Development
Continuous Improvement
Establish full lab KPI tracking system: testing TAT, pass rate, OOS frequency, on-time CAPA closure, instrument downtime etc.;
Identify opportunities to boost lab efficiency, compliance and cost savings, evaluate new analytical hardware and LIMS/CDS automation tools;
Deploy Lean, Six Sigma and other methodologies to drive lab workflow optimization and quality enhancement projects.
Team Leadership & Development
Build, mentor and motivate QC team, including Associate Director, Validation Manager, supervisors and analysts;
Set clear performance objectives, individual development plans and internal succession pipeline;
Build tiered training matrix covering new hire GMP onboarding, instrument operation, advanced regulatory and management training, conduct regular competency assessments;
Manage full annual QC budget covering labor, consumables, equipment calibration and outsourced testing, continuously reducing operational expenditure;
Complete other ad-hoc assignments assigned by Site Quality Head; strictly protect confidential client data, peptide processes and company proprietary information.
Competencies
Strategic Governance: Capable of full greenfield lab end-to-end planning, budget and capacity scheduling for overseas facility;
Technical Expertise: SME on peptide impurity, chiral, sterility, endotoxin testing, able to independently resolve complex lab technical challenges;
Risk Control: Strong capability to proactively identify and mitigate risks related to GMP, data integrity, sample retention and instrument compliance;
Leadership: Experienced in building, motivating and retaining local lab teams with clear succession planning;
Communication & Documentation: Excellent cross-functional, US-China HQ, regulatory and client communication plus formal regulatory writing capability;
Other Duties:
Other duties as assigned.
Essential Physical and Mental Requirements
Physical Requirements:
Ability to sit at a desk for extended periods.
Ability to extensively use computer keyboard, mouse and monitor and chromatography and other lab equipment
Ability to lift at least 25 +/- pounds, e.g., materials, samples and archives.
Ability to work in a venue such as a lab, office environment, hotel/conference room, etc., with the possible inclusion of working on the weekends during and after site construction and commissioning phase;
Ability to walk, bend, stoop, kneel, twist, turn and use/walk up ladder/stairs, etc., and wear required personal protective equipment (PPE) when needed and access cleanroom labs or manufacturing areas when required.
Mental Requirements:
§ Ability to work with frequent interruptions and changes in workload priorities and the ability to maintain confidentiality.
§ Ability to utilize excellent analytical, organizational skills and problem-solving skills.
§ Ability to manage multiple priorities and delegate responsibilities while maintaining regulatory compliance and operational excellence.
§ Ability to be an independent, self-motivated individual, working in a GMP manufacturing environment with tight schedules.
§ Ability to utilize strong written and verbal communication skills, being responsive in a timely manner and able to work effectively as part of a team and with regulatory agencies and customers.
Ability to use various tools: Master MS Office, proficient with LIMS and chromatography data systems (Empower, Chromeleon etc.).
Ability to exhibit proficient knowledge and use of English communication skills, e.g., reading, writing and speaking.
Travel:
§ Valid drivers’ license and insurance required.
§ Ability to travel domestically by car or commercial means up to 10% of the time. Valid passport is required and ability to travel to China, if needed.
Other:
§ The above is a list of essential duties and responsibilities for this position. This list is not all-inclusive. This job description may be modified at any time as needed.
§ CPC is an equal-opportunity employer. A pre-employment background check will be required.Bottom of Form
Requirements
Qualifications:
Education:
Master’s degree in Organic/Analytical Chemistry, Pharmacy, Biochemistry, Pharmaceutical Sciences, or related scientific discipline is required. Ph.D. preferred.
GMP internal auditor or FDA compliance training certificates a plus.
Work Experience
Minimum 8 years progressive QC experience in GMP peptide/oligonucleotide/API CDMO environment;
Minimum 5 years end-to-end lab leadership experience overseeing multiple streams (analytical/micro/validation);
Comprehensive expertise in FDA, ICH, EU GMP, USP with proven track record leading FDA and client regulatory audits;
5+ years hands-on management of OOS/OOT, deviation, CAPA and root cause investigations;
5+ years full lifecycle governance of analytical method development, validation and transfer;
5+ years’ experience reviewing & approving lab data, validation reports and CoAs;
Preferred: Prior QC management at US pharma/CDMO site, greenfield GMP lab build experience
