Join Our Rapidly Growing CPC Scientific Family
CPC Scientific is a globally recognized and leading CRDMO specializing in synthetic peptide production. We work directly with leaders in the biotechnology and pharmaceutical industries to help bring life-changing therapeutics and diagnostics to market. With 400+ employees globally, CPC Scientific is growing rapidly and always looking for exceptional talent.
Our Scientific Team
CPC Scientific is a research and development-focused company with a global team of 500+ employees, of whom more than 39% hold master’s or doctoral degrees in R&D.
Employee Distribution by Job Area
Employment Breakdown by College Degree
Job Openings
Summary
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 an Operations Head or VP of Manufacturing to fill a full-time, onsite position in our Rocklin, California facility. This position will report directly to the CEO.
This position is considered as a top executive with full P&L ownership in the new GMP peptide CDMO facility to guarantee long-term compliant, profitable and stable site operation. This position is responsible for end-to-end overall accountability for site business performance, commercial peptide manufacturing, full-site quality compliance, capital construction & facility maintenance, global supply chain, EHS management, team leadership, budget control, client and regulatory liaison. This position will lead the full site lifecycle from construction closeout, equipment qualification, trial production through stable commercial launch in Q4 2026. In addition, this position will align with corporate business strategy, formulate annual site targets, CAPEX & OPEX budgets, as well as, maintain permanent inspection readiness for FDA, OSHA, EPA and all client/regulatory audits. The position will build local leadership team, oversee on-time delivery of commercial peptide synthesis, purification and fill-finish CDMO programs. Also will be responsible for the five core site goals – safety, environmental compliance, quality, on-time delivery and cost efficiency. This position will balance client commitments, regulatory risk and operational profitability, establish sustainable talent pipeline and risk-based quality & safety culture.
This position will interact with all levels within the organization. Professionalism and maintaining confidentiality are an integral part of the job.
Duties
Site Business & Strategic Leadership:
- Execute corporate global peptide CDMO strategy, develop medium-long term site roadmap, annual revenue & gross profit targets;
- Hold full site P&L accountability, formulate, approve and execute yearly OPEX & CAPEX budgets, continuously optimize manufacturing, capital and labor costs;
- Lead monthly/quarterly site executive business reviews to track delivery, quality, safety, cost and supply chain KPIs, identify business risks and drive corrective actions;
- Liaise with corporate senior leadership of Operations, Finance and Commercial, submit regular site business performance reports and escalate major projects, audits, safety & compliance events;
- Interface with senior stakeholders of global pharma clients, coordinate large-scale project scheduling, delivery and quality disputes to boost client retention & satisfaction.
Manufacturing & CDMO Production Oversight:
- Full oversight of clinical and commercial peptide DS/DP manufacturing workflows: synthesis, purification, fill-finish and packaging;
- Oversee production scheduling and capacity planning to deliver parallel multi-client, multi-product CDMO orders on schedule;
- Ensure manufacturing strictly follows approved processes & batch records, coordinate with QA on batch release, production deviations, change control and CAPA closure;
- Drive technology transfer, process validation and cleaning validation, resolve bottlenecks for large-scale peptide commercial production;
- Monitor yield, material loss and labor efficiency goals to continuously boost manufacturing productivity.
Site Quality & Regulatory Compliance:
- Full ownership of site GMP compliance, provide unified leadership to QA Director and QC Director, oversee lab, manufacturing and document QMS operation;
- Ensure all site activities comply with FDA 21CFR, EU GMP, ICH, USP, OSHA, EPA and California local environmental & building codes;
- Site lead for all FDA, third-party and client audits, coordinate document preparation, site walkthrough and full observation remediation;
- Roll out site-wide ALCOA+ data integrity and ICH Q9 risk assessment plus continuous quality improvement programs;
- Approve critical site quality documents, quality agreements and regulatory submission materials, resolve cross-functional major quality matters.
Facilities, Capital Project & EHS Governance:
- Lead all greenfield closeout, cleanroom, lab and utility (HVAC/WFI/gas) construction, renovation and expansion capital projects for Q4 2026 launch;
- Direct facilities team to establish standardized preventative maintenance program for long-term stable peptide production equipment & utilities;
- Hold ultimate site EHS accountability, build OSHA-compliant workplace safety, EPA hazardous waste/emission control and emergency response frameworks;
- Schedule regular safety rounds and emergency drills to eliminate fire, chemical and cleanroom operational hazards;
- Oversee facility validation and equipment IQ/OQ, collaborate with quality teams to maintain utility GMP compliance.
Supply Chain, Procurement & Cross-Functional Collaboration:
- Oversee end-to-end site supply chain including procurement, inventory, warehouse and cross-border import/export logistics to guarantee stable supply of peptide APIs, reagents, instruments and packaging;
- Supervise supplier qualification, on-site audits and performance review to mitigate single-source supply risks;
- Collaborate with Validation & Engineering teams on equipment and raw material procurement for new process transfers;
- Partner with Finance on payment & cost accounting, align with HR on employee related matters;
- Administer site admin, IT and support functions to backstop core manufacturing & quality operations.
Team Leadership & Continuous Improvement:
- Build, mentor and motivate site leadership and staff, establish management succession pipeline;
- Set department head performance targets and conduct regular performance reviews & career development discussions;
- Cultivate site culture focused on safety, compliance, customer focus and operational excellence;
- Deploy Lean, Six Sigma and other continuous improvement initiatives to cut risks and overall operating costs;
- Maintain confidentiality protocols to protect proprietary peptide processes, client formulas and core business data; complete other ad-hoc overseas site assignments from global leadership.
Competencies:
- Business Acumen: End-to-end P&L decision-making, balance production demand, compliance risk and commercial profit;
- Regulatory Risk Forecasting: Proactively mitigate major FDA/EPA/OSHA violations under US multi-agency oversight;
- Greenfield Project Leadership: Align timeline, quality and cost across construction, validation and trial production phases;
- Leadership: Motivate, resolve conflicts and retain management team;
- Executive Communication: C-level negotiation with global pharma clients & formal reporting to corporate global leadership;
Other Duties:
- Other duties as assigned.
Qualifications
Education:
- Master’s degree in Organic Chemistry, Peptide Chemistry, Pharmaceutical Engineering or BioPharma is required. Ph.D. degree is preferred.
- Certificates in OSHA 30, GMP Internal Auditor, US Pharmaceutical compliance training certificates preferred.
Work Experience:
- 12+ years end-to-end GMP peptide/API CDMO comprehensive management experience,
- Minimum 5 years full site General Manager track record at a pharma facility;
- Mandatory greenfield GMP plant launch experience covering construction, validation, trial batches to full commercial production;
- In-depth, comprehensive knowledge of FDA, EU GMP, OSHA, EPA US local regulatory landscape, proven track record leading full-site FDA inspections;
- Extensive capacity planning, process scale-up and multi-client CDMO program oversight for commercial peptide synthesis & purification;
- Hands-on full P&L ownership, annual CAPEX/OPEX budgeting and cost optimization experience;
- Experience building a workforce in the USA of 100+ employees and managing site leadership team.
- Expertise in ERP, LIMS, project management, budgeting software and MS Office Suite.
Essential Physical and Mental Requirements
Physical Requirements:
- Ability to sit at a desk for extended periods.
- Ability to extend on-site office hours during the week/weekends when needed for executive meetings, business & capital document drafting, construction & commissioning.
- Ability to extensively use computer keyboard, mouse and monitor.
- Ability to lift at least 25 +/- pounds.
- 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.
- Ability to have regular access to cleanrooms, equipment rooms and hazardous waste zones with full PPE.
- Ability to walk, bend, stoop, kneel, twist, turn and use/walk up ladder/stairs, etc, as well as, conduct full-site walkthroughs.
Mental Requirements:
- Ability to work with frequent interruptions and changes in workload priorities and the ability to maintain confidentiality.
- Ability to utilize excellent analytical and organizational skills.
- Ability to manage multiple priorities and delegate responsibilities while maintaining quality.
- Ability to be an independent, self-motivated individual, working in a fast-paced team 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.
- 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.
Salary Range: $200,000 – $250,000 DOE.
QUALIFIED APPLICANTS SHOULD SEND THEIR RESUME TO: hr@cpcscientific.com
Summary
CPC Scientific 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 Scientific 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 Scientific is seeking a QA Director, to fill a full-time, on-site role in our Rocklin, CA facility. This position will report directly to the CEO and is responsible for overseeing the strategic planning and operational delivery of all QA functions at the new greenfield peptide CDMO manufacturing site.
Will lead the full-lifecycle quality governance throughout site construction, facility validation, trial production and commercial launch. Will establish comprehensive QMS and document control framework fully compliant with FDA 21 CFR Part 210/211, EU GMP, ICH Q Guidelines, USP & EP. Will be responsible for the end-to-end ownership of batch release, deviation/change control/CAPA, validation, data integrity, audit readiness and client quality liaison. This position will build the QA team, manage annual department budget, embed risk-based quality culture, enable smooth commercial commissioning in Q4 2026, sustain permanent regulatory inspection readiness, and ensure consistent compliant & efficient operation of the site quality management system.
This position will interact with all levels within the organization. Professionalism and maintaining confidentiality are an integral part of the job.
Duties
Quality Leadership & Strategy:
- Develop medium & long-term site quality strategy aligned with multi-client, multi-product commercial peptide CDMO business objectives, deliver annual quality roadmap, department KPIs and yearly budget plan;
- Act as the quality representative in leadership meetings, report quality trends, compliance risks and critical quality incidents to Site Quality Head and China HQ;
- Establish unified site-wide quality culture, cascade compliance-first, proactive risk and data integrity mindset across all departments;
- Benchmark against global top-tier peptide CDMO quality standards, continuously optimize site quality governance model and formulate long-term quality improvement roadmap.
GMP Compliance & Regulatory Oversight:
- Take full ownership of site-wide compliance with FDA 21 CFR Part 210/211, ICH Q7/Q9/Q10, EU GMP, USP/EP and all applicable global regulatory standards;
- Sustain permanent site inspection readiness, fully lead FDA, EMA and other global regulatory on-site inspections, serve as primary site QA contact during all regulatory visits;
- Review regulatory submissions, quality agreements, inspection observation responses and remediation CAPA reports, ensure full compliance with all regulatory documentation;
- Monitor ongoing regulatory and pharmacopoeia updates globally, timely revise internal QMS documents and deliver site-wide regulatory training sessions;
- Govern end-to-end third-party GMP audits and client quality audits, coordinate document preparation, on-site walkthrough, observation classification, corrective action planning and full closure.
Peptide Manufacturing & CDMO Support:
- Deliver full QA oversight over commercial peptide synthesis, purification, fill-finish and packaging operations, covering pilot, scale-up and full commercial production batches;
- Lead full QA governance for technology transfer, manufacturing process changes and process validation, assess quality risks associated with peptide manufacturing workflows;
- Hold full authority for batch release of peptide drug substances, intermediates and drug products, conduct comprehensive evaluation of batch records, test results, deviations and validation status to issue release decisions;
- Act as dedicated QA liaison for global CDMO clients, align with contractual quality requirements, respond to client quality inquiries, coordinate audit, sample and regulatory filing related quality matters;
- Lead cross-functional investigations for client complaints and product quality deviations, design long-term corrective and preventive actions to guarantee stable delivery of client programs.
Documentation & Quality Systems:
- Oversee construction and continuous maintenance of full site Quality Management System (QMS), including SOPs, manufacturing procedures, specifications, all forms of records, validation documents and batch record systems;
- Full ownership of Document Control QA team, build integrated paper & electronic document control workflow, standardize full document lifecycle: drafting, review, approval, issuance, retrieval, revision, obsolescence, destruction and scanning archiving;
- Manage archive room layout design, records archiving, borrowing, traceability and confidentiality control; centralized controlled management of batch records, validation protocols/reports, regulatory submission files and client quality documents;
- Drive deployment of digital document management system, LIMS and CDS, strictly enforce ALCOA+ data integrity and compliance of electronic records & electronic signatures;
- Coordinate document transmission on official regulatory platforms, establish site-wide document confidentiality and tiered access control mechanism to prevent information leakage.
Risk Management & Continuous Improvement:
- Establish and implement site-wide quality risk management framework in alignment with ICH Q9, cover risk assessment of facilities, equipment, manufacturing processes, analytical methods, documentation, data integrity and supply chain;
- Govern closed-loop management of deviations, OOS/OOT, change controls and CAPAs, organize cross-functional root cause analysis, tier risks and track remediation effectiveness;
- Build monthly/quarterly quality KPI monitoring system (deviation frequency, CAPA on-time closure rate, audit observation count, batch release turnaround time etc.), compile quality trend analysis reports for leadership review;
- Organize internal mock FDA audits and periodic self-inspections, proactively identify potential compliance gaps and implement preventive actions;
- Lead site-wide continuous quality improvement initiatives to streamline workflows, mitigate compliance risks and boost efficiency of document control and batch release activities.
Team Leadership & Development:
- Design onsite tailored QA organizational structure covering Document Control, Compliance & Audit, Batch Release and QMS Specialist streams, oversee team recruitment, role assignment, performance appraisal and daily workload allocation;
- Specially manage Document Control QA staff, build tiered training matrix covering GMP regulations, document operation, confidentiality management and audit response to continuously upgrade team competency;
- Set individual performance objectives and career development paths for each team member, build local US quality talent pipeline and retain core specialists;
- Administer full annual QA department budget including labor cost, digital document management system, archive supplies, outsourced validation and audit consulting, continuously optimize operational expenditure;
- Implement EHS standards for all QA roles, standardize safety management of chemical reagents and paper archives in storage rooms, foster a safe, compliant and positive team working environment.
Competencies:
- Strategic Planning: Capable of designing overseas greenfield site quality strategy and long-term QMS framework, adapt to multi-client peptide CDMO business model;
- Compliance & Risk Control: Strong capability to proactively identify and mitigate risks related to GMP, data integrity and document confidentiality;
- Business Support: Deep understanding of commercial peptide synthesis, purification and fill-finish workflows, able to independently resolve all types of CDMO client quality requirements;
- Team Leadership: Experienced in building & motivating teams with specialized development experience for document control staff;
- Communication & Documentation: Excellent cross-functional, US-China HQ, client and regulatory communication, negotiation and formal regulatory drafting skills;
Other Duties:
- Other duties as assigned.
- Closely collaborate with Manufacturing, QC, Process Development, EHS and Procurement on supplier qualification audits, cleaning validation, environmental monitoring and quality risk assessment;
- Strictly protect confidential client manufacturing processes, testing data and commercial information, safeguard overall site information security.
Qualifications
Education:
- Master’s degree or above in Pharmacy, Pharmaceutical Engineering, Chemistry, Biopharmaceutics or Peptide-related majors. MS/Ph.D. in Pharmaceutical, Organic or Analytical Chemistry preferred.
- GMP internal auditor or FDA compliance training certificates preferred.
Work Experience:
- Minimum 5 years QA experience in peptide / pharmaceutical CDMO industry, with at least 4 years QA team management experience, proven track record overseeing Document Control QA function;
- In-depth knowledge of domestic & international GMP, FDA 21 CFR Part 210/211, ICH Q7/Q9/Q10, EU GMP, USP & EP, full mastery of end-to-end workflows in above listed job duties;
- Direct lead experience for FDA & EU regulatory on-site inspections and global client CDMO audits, with successful track record of observation remediation and CAPA closure;
- Greenfield GMP site experience in document control system build-up, archive room design and electronic document system rollout is strongly preferred;
- Prior QA management experience at USA based peptide/pharma CDMO site is a major plus.
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 other lab equipment.
- Ability to lift at least 25 +/- pounds.
- 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 archive rooms, cleanroom labs or manufacturing areas when needed.
- Ability to conduct on site quality walkthroughs.
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 English communication skills, being responsive in a timely manner and able to work effectively as part of a team with regulatory agencies and customers.
- Fluent English for independent communication with FDA & global clients, drafting regulatory response documents;
- Computer Skills: Skilled in MS Office, practical experience with document management systems, LIMS & CDS.
- 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.
Salary Range: $175,000 – $225,000 DOE.
QUALIFIED APPLICANTS SHOULD SEND THEIR RESUME TO: hr@cpcscientific.com
Summary
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:
- 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.
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
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.
Salary Range: $150,000 – $200,000 DOE.
QUALIFIED APPLICANTS SHOULD SEND THEIR RESUME TO: hr@cpcscientific.com
We’re always looking for talented people to join our team!
CPC Scientific is a globally recognized and leading CRDMO specializing in synthetic peptide and oligonucleotide production, with one of the largest research peptide facilities in the world and 400+ employees globally. CPC Scientific 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.
Qualified candidates who are interested in applying for our positions should submit their CV’s to hr@cpcscientific.com. If there is any interest in a candidate, HR will contact the candidate directly.
CPC Scientific does not accept unsolicited resumes or candidate information from recruiters or employment agencies. In the event a recruiter or agency submits a resume or candidate information without a previously signed agreement and a specific solicitation for the position or other approved engagement request for the position with CPC Scientific, CPC Scientific reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. All unsolicited submittals of resumes or candidates to CPC Scientific are done at the risk of the recruiter or agency and will be considered property of CPC Scientific.
Life at CPC Scientific
Annual Conference 2025
Past Events
