Senior Director, Quality Control

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking an experienced Senior Director, Quality Control to join as a key leader within Crescent's Quality organization, responsible for providing strategic and hands-on Quality Control leadership across company’s biologics and ADC programs, and future pipeline growth. Partnering closely with Analytical Sciences, GMP Quality Assurance, CMC/Technical Operations, Supply Chain, and Regulatory Affairs, you will provide phase-appropriate QC oversight from early development through late-stage development and commercialization within a global outsourced testing and manufacturing network. You will ensure reliable release and stability testing while building the QC infrastructure, laboratory network, and operating controls needed to advance programs into Phase 3, PPQ, BLA/MAA submission, and commercial readiness.
Crescent's operating model requires clear, collaborative accountability between Analytical Sciences and QC. Analytical Sciences leads analytical development and performs the primary technical work through method development, characterization, qualification, validation strategy, and PPQ readiness. QC provides oversight and operational input during early development, assumes increasing responsibility for method transfer, validation execution oversight, laboratory readiness, and GMP testing as programs mature, and takes primary ownership of routine QC operations and analytical method lifecycle management following transition to late-stage and commercial operations.

Success in this role requires a collaborative, hands-on leader who understands both analytical development and commercial QC operations, can establish effective governance across internal and external partners, and thrives in a fast-paced biotechnology environment while balancing scientific rigor, compliance, speed, and pragmatism.

Responsibilities

• Define and implement Crescent's phase-appropriate QC strategy and operating model across early development, Phase 3, PPQ, regulatory submission, and commercialization, with clear decision rights and handoffs among Analytical Sciences, QC, and GMP QA.

• Oversee QC activities for drug substance, drug product, intermediates, finished goods, in-process, release, characterization, and stability testing across the portfolio.

• Provide QC oversight and operational requirements during early development while Analytical Sciences leads method development, characterization, qualification, validation strategy, and method maturation through PPQ readiness.

• Partner with Analytical Sciences on integrated Phase 3 and PPQ readiness, including method validation and transfer, laboratory qualification, specifications, reference standards and critical reagents, stability, sample management, and testing timelines.

• Lead QC execution oversight for method transfer, validation, and laboratory readiness; following transition to GMP QC operations, own routine method lifecycle management, performance monitoring, changes, revalidation, transfers, and remediation.

• Lead outsourced GMP QC operations, including sample management and testing coordination, and ensure timely, compliant release and stability testing for clinical supply, PPQ, batch disposition, regulatory commitments, and future commercial supply.

• Partner with Analytical Sciences, CMC, Regulatory Affairs, and QA on specifications and stability strategy; lead operational implementation, stability execution, data review, trending, and escalation within the QC network.

• Establish and oversee reference standard and critical reagent programs, including qualification, bridging, inventory, monitoring, replacement, and lifecycle planning.

• Provide technical leadership for OOS, OOT, OOE, atypical results, invalid assays, laboratory deviations, CAPAs, and change controls, ensuring scientifically sound, timely investigations and risk-based escalation.

• Lead selection, onboarding, qualification, governance, and performance management of CDMO QC functions and contract laboratories, including agreements, capacity, metrics, issue management, data integrity, and inspection readiness.

• Provide QC input to CMC and regulatory strategies and support IND/IMPD, BLA/MAA, health authority, and inspection activities; ensure commitments are implemented within the laboratory network.

• Lead alliance management with business partners on QC matters, including governance, roles and responsibilities, shared testing and release requirements, issue escalation, decision-making, and alignment on development, regulatory, and future commercial priorities.

• Establish scalable QC procedures, systems, metrics, budgeting, forecasting, and resource plans; support compliant use of LIMS, stability, analytical data, and trending tools, and build internal QC capability as Crescent advances toward commercialization.

• Mentor staff and consultants and foster a culture of scientific rigor, collaboration, accountability, inclusion, and continuous improvement while staying current with evolving GMP, ICH, compendial, and industry expectations.

Education & Experience

• Bachelor's degree in life sciences, analytical sciences, biochemistry, pharmaceutical sciences, or a related discipline; advanced degree preferred.

• A minimum 10-12 years of progressive experience in biologics QC, analytical development, or related CMC functions, including leadership of GMP QC operations in an outsourced environment.

• Experience with biologics analytical methods, including cell-based bioassays/potency assays; ADC and other complex biologic modality experience is preferred.

• Experience supporting biologics from clinical development through Phase 3, PPQ, BLA/MAA, and commercial readiness; bispecific antibody, ADC, or other complex modality experience is a plus.

• Proven experience transitioning methods from development into routine GMP QC use, including qualification, validation, transfer, implementation, performance monitoring, and lifecycle management.

• Strong experience with release and stability testing, specifications, reference standards and critical reagents, OOS/OOT/OOE investigations, analytical trending, deviations, CAPAs, and change control.

• Demonstrated success overseeing CDMO QC functions and contract laboratories, including qualification, governance, investigations, capacity, performance, and issue resolution.

• Strong knowledge of global GMP regulations, FDA/EMA/ICH guidance, compendial expectations, data integrity, Part 11 / Annex 11, and phase-appropriate application across development and commercial operations.

• Experience supporting regulatory submissions, health authority questions, pre-approval inspections, and commercial inspection readiness.

• Ability to establish clear roles and effective collaboration among Analytical Sciences, QC, GMP QA, CMC/Technical Operations, Regulatory Affairs, Supply Chain, and external partners.

• Strategic thinker with a hands-on approach, solutions-oriented leader who communicates clearly, applies pragmatic science- and risk-based judgment, works effectively in a fast-paced small-company environment, and can travel to external sites as needed.

• Commitment to living Crescent’s core values and operating norms.

What We Offer

• Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment

• Competitive compensation, including base salary, performance bonus, and equity

• 100% employer-paid benefits package

• Flexible PTO

• Two, one-week company-wide shutdowns each year

• A commitment to your professional development, with access to resources, mentorship, and growth opportunities

Salary Range

The salary range for this position is $260,000 to $285,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Additional Description for Pay Transparency:

The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits

Please note:

Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.

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