Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s 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 either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visitwww.crescentbiopharma.comand follow the Company onLinkedInandX.
We are seeking an Associate Director or Director, Analytical & Operational Quality Assurance who will be responsible for providing strategic and hands-on QA oversight of analytical development, QC operations, and GMP operational quality activities across Crescent’s clinical-stage biologics and ADC programs. You will partner closely with CMC, Analytical Sciences, Quality Control, Technical Operations, and external manufacturing and testing partners to ensure phase-appropriate GMP compliance, robust data integrity, and inspection readiness within a highly outsourced operating model. In this role, you will play a critical role in shaping Crescent’s analytical quality strategy while ensuring disciplined execution of core quality systems that support aggressive development timelines.
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s 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 either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visitwww.crescentbiopharma.comand follow the Company onLinkedInandX.
We are seeking an Associate Director or Director, Analytical & Operational Quality Assurance who will be responsible for providing strategic and hands-on QA oversight of analytical development, QC operations, and GMP operational quality activities across Crescent’s clinical-stage biologics and ADC programs. You will partner closely with CMC, Analytical Sciences, Quality Control, Technical Operations, and external manufacturing and testing partners to ensure phase-appropriate GMP compliance, robust data integrity, and inspection readiness within a highly outsourced operating model. In this role, you will play a critical role in shaping Crescent’s analytical quality strategy while ensuring disciplined execution of core quality systems that support aggressive development timelines.
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.
Responsibilities
Lead and execute QA oversight for analytical development and QC activities for assigned development programs and provide QA oversight across GMP manufacturing of master cell bank, working cell bank, drug substance, and drug product/finished goods, in alignment with Crescent’s Quality SystemServe as the primary QA interface to Analytical Sciences and Quality Control teams, ensuring quality is embedded in analytical strategies and executionProvide QA oversight of analytical method development, qualification, validation, transfer, and lifecycle managementLead QA oversight of OOS/OOT/OOE investigations, analytical deviations, and data integrity eventsOversee QA aspects of stability programs, reference standards, analytical trending, and method performance monitoringProvide QA oversight of GMP operational activities, including manufacturing, testing, batch record review, disposition, and release of clinical materialsSupport QA governance for tech transfer, scale-up, and validation/qualification activities (PPQ, cleaning, facilities, utilities, equipment)Provide QA oversight of external QC laboratories, CDMOs, and key suppliers, including qualification, audits, Quality Agreements, and issue managementExecute and support core GMP quality systems, including deviations, investigations, CAPAs, change control, CPV, and batch reviewPartner with Regulatory and CMC teams to support analytical and CMC sections of INDs, IMPDs, BLAs, and MAAs, and respond to health authority inquiriesSupport regulatory inspections, partner audits, and ensure inspection readiness across analytical and operational areasSupport implementation and use of electronic quality systems (eQMS, DMS, LMS), ensuring compliance with Part 11 / Annex 11 and data integrity expectations for GMP recordsContribute to quality risk management activities by identifying, assessing, and escalating analytical and operational quality risks; propose mitigation strategies in partnership with Quality ManagementSupport GDP-related interfaces for assigned programs, including labeling/packaging operations, temperature excursions, complaints, returns, and QP Declaration, Certification, and release coordinationTrack and report program-level GMP quality metrics and trends; support continuous improvement initiatives across manufacturing and supply operationsMentor junior QA staff and external consultants as applicable, contributing to a strong quality culture grounded in collaboration, accountability, and continuous learningStay current on evolving GMP regulations, guidance, and industry best practices, and proactively apply learnings to Crescent’s operationsEducation & Experience
B.S. in life sciences or a related discipline; advanced degree preferred;10–12+ years of progressive experience with demonstrated leadership in GMP Quality Assurance within biotech or pharmaceutical development, with significant analytical and QC oversight experienceStrong working knowledge of global GMP regulations and guidance (FDA, EMA, ICH) and phase-appropriate application for clinical-stage biologicsHands-on experience supporting biologics manufacturing, including drug substance and drug product operations; experience with ADCs or complex modalities is a plusProven experience providing QA oversight of CDMOs and external QC laboratories, including audits, investigations, change management, and issue resolutionExperience supporting regulatory submissions and inspections, including preparation of analytical and CMC-related documentation and health authority interactionsSolid understanding of validation principles, batch release processes, and analytical and stability programsDemonstrated ability to operate effectively in a highly outsourced, fast-paced environment with evolving prioritiesStrong collaboration, communication, and influencing skills, with the ability to balance compliance rigor and development agilityHands-on, solutions-oriented mindset with the judgment to escalate issues appropriately and propose pragmatic, risk-based solutionsCommitment to fostering a culture of quality, integrity, inclusion, and continuous improvement
