Senior Director, Quality Control

Crescent Biopharma•Waltham, MA

6d•$260,000 - $285,000

About The Position

Crescent Biopharma is seeking an experienced Senior Director, Quality Control to provide strategic and hands-on QC leadership across its biologics and ADC programs and future pipeline. The role partners with Analytical Sciences, GMP Quality Assurance, CMC/Technical Operations, Supply Chain, Regulatory Affairs, and external partners to provide phase-appropriate oversight from early development through late-stage development and commercialization within a global outsourced testing and manufacturing network. The Senior Director will ensure reliable release and stability testing while building the QC infrastructure, laboratory network, and operating controls required for Phase 3, PPQ, BLA/MAA submission, and commercial readiness. Crescent's operating model defines collaborative accountabilities between Analytical Sciences and QC. Analytical Sciences leads analytical development and 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 after transition to late-stage and commercial operations. The successful candidate will be a collaborative, hands-on leader who understands analytical development and commercial QC operations, establishes effective governance across internal and external partners, and balances scientific rigor, compliance, speed, and pragmatism in a fast-paced biotechnology environment.

Requirements

Bachelor's degree in life sciences, analytical sciences, biochemistry, pharmaceutical sciences, or a related discipline.
A minimum of 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 and potency assays.
Experience supporting biologics from clinical development through Phase 3, PPQ, BLA/MAA, and commercial readiness.
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 and solutions-oriented leadership; 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.

Nice To Haves

Advanced degree.
ADC and other complex biologic modality experience.
Bispecific antibody, ADC, or other complex modality experience.

Responsibilities

Define and implement Crescent's phase-appropriate QC strategy and operating model across early development, Phase 3, PPQ, regulatory submission, and commercialization, including 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; after 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.

Benefits

Competitive compensation, including base salary, performance bonus, and equity.
100% employer-paid benefits package.
Flexible PTO, including unlimited vacation PTO.
Two one-week company-wide shutdowns each year.
Professional development resources, mentorship, and growth opportunities.
Medical, dental, vision, life insurance, and short- and long-term disability benefits.
401(k) savings plan.
Long-term incentive program.
10 sick days per calendar year.
Holiday pay, including company shutdowns.
16 weeks of parental leave, subject to policy terms and eligibility.
FMLA and military leave.