Senior Director, Quality Control

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.

• 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.

• 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.

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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