Senior Director / Executive Director, Quality Control

Job Description

Job DescriptionAbout UsCrescent 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 either as single agents or 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. Position OverviewCrescent Biopharma is seeking an accomplished Senior Director / Executive Director of Quality Control (QC) to provide strategic, scientific, and operational leadership for the QC function across the company’s biologics pipeline. This role will own the end‑to‑end QC strategy, including analytical control strategy, externalized QC operations, and regulatory readiness from early clinical development through late‑stage development and commercialization. The ideal candidate is a seasoned QC leader with deep expertise in analytical method lifecycle management, strong experience overseeing global CDMOs and contract laboratories, and a proven ability to build scalable, phase‑appropriate QC systems in a lean biotech environment. This role will be a key member of the CMC/Tech Ops leadership team and a critical partner to QA, Regulatory, and Program Leadership.Responsibilities

• Strategic Leadership

• Define and lead Crescent’s global QC strategy across all development stages, ensuring alignment with overall CMC and corporate objectives.
• Establish and evolve a phase appropriate analytical control strategy to support clinical development, regulatory filings, and future commercialization.
• Serve as a QC subject matter expert and thought partner to senior leadership.

• Analytical Methods & QC Operations
• Oversee the qualification, validation, and lifecycle management of analytical methods for biologics, including potency, purity, identity, and safety assays.
• Provide executive oversight of method transfers, method readiness, and routine testing execution at CDMOs and contract laboratories.
• Ensure compliant execution of release, stability, and in process testing in accordance with GMP requirements, Crescent standards, and global regulatory expectations.

• Vendor & Partner Oversight
• Lead selection, governance, and performance management of external QC vendors, ensuring technical excellence, compliance, and reliable delivery.
• Oversee QC related investigations at CDMOs, including OOS/OOT, deviations, CAPAs, and change controls.
• Review and approve key QC deliverables, including analytical protocols, validation reports, method transfer reports, and Certificates of Analysis.

• Cross Functional & Regulatory Partnership
• Partner closely with Process Development, MSAT, QA, Regulatory Affairs, and Program Teams to ensure QC strategies support product understanding and overall control strategy.
• Provide leadership and technical input into CMC and analytical sections of regulatory submissions (IND, IMPD, BLA/MAA).
• Support interactions with global health authorities as a QC and analytical expert.

• Systems, Compliance & Organization Building
• Establish and continuously improve QC systems, procedures, and governance models suitable for a lean, scalable organization.
• Ensure strong data integrity, GMP compliance, and inspection readiness across all QC activities.
• Build, mentor, and develop internal QC capabilities as the organization grows.
• Own QC budgets, forecasting, and long-range planning.

Education & Experience

• B.S., M.S., or Ph.D. in Biology, Biochemistry, Immunology, Analytical Sciences, or a related discipline.
• 15+ years of progressive experience in biologics analytical development and Quality Control, with significant leadership responsibility.
• Demonstrated expertise in analytical method validation, lifecycle management, and control strategy development.
• Extensive experience managing externalized QC models and global CDMOs.
• Strong knowledge of GMP, data integrity principles, and ICH guidelines (Q2, Q5, Q6, Q14).
• Proven experience supporting late‑stage development and regulatory filings and engaging with health authorities.
• Track record of building QC organizations and processes in small or virtual biotech environments.
• Excellent leadership, communication, and cross‑functional influencing skills.

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.

The anticipated base pay range for this position is:The anticipated salary range for candidates for this role at the Senior Director level is $250,000 – $280,000 and at the Executive Director level is $285,000-$305,000. 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: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 through the link below. https://www.crescentbiopharma.com/careers/#benefits E-Verify:Crescent Biopharma, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires. __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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.