Associate Director, Quality Control

Crescent Biopharma; Waltham (MA); On-site; USD 160,000 - 200,000; Full time

Benefits offered by this job

Benefits package

Equity

Job summary

Crescent Biopharma is seeking an experienced Associate Director of Quality Control to lead QC operations for our biologics pipeline in a biotech setting. You will oversee analytical testing at CDMOs/CTLs, ensure robust stability and specification programs, and drive quality across release and data integrity activities.

Based in Waltham, MA, this role requires deep biotech QC expertise, leadership, and the ability to manage complex regulatory expectations for IND/IMPD/BLA submissions.

Qualifications

• BS or MS in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Minimum 10 years of industry experience in biologics analytical development and QC.
• Deep expertise in method qualification, validation, and lifecycle management.
• Experience overseeing QC activities at CDMOs/CTLs.

Responsibilities

• Lead QC operations across the biologics pipeline, reporting to head of QC.
• Manage stability, specification, and reference standard programs for early and late stages.
• Ensure CDMOs/CTLs perform release, stability and in-process testing per GMP and Crescent standards.
• Review and approve batch records, COAs, and stability data.
• Support regulatory submissions (IND/IMPD/BLA) with QC input.

Skills

GMP compliance

Data integrity

Leadership

Cross-functional

QC operations

Analytical method transfer

Education

BS/MS in Biology/Chemistry/related

Tools

Veeva Vault QualityDoc

LIMS

GraphPad Prism

JMP

Job description

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 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.

We are seeking an experienced Associate Director of Quality Control (QC) to lead QC operations across the company’s biologics pipeline. You will report directly to the head of QC and will serve as key contributor in overseeing day-to-day QC activities and analytical testing at CDMOs and contract testing laboratories (CTLs). You must have deep expertise in stability, specification, reference standard programs management, analytical method transfer, qualification/validation. and a proven track record overseeing external testing labs in a GMP environment; you will also be responsible for ensuring robust, phase‑appropriate QC operations supporting Crescent’s biologics pipeline. This role is based in Waltham, MA and you must have experience in biotech.

Responsibilities

• Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products
• Serve as QC point of contact for CDMOs/CTLs ensuring appropriate quality control oversight of manufacturing campaigns
• Ensure CDMOs/CTLs perform release, stability and in-process testing in accordance with GMP requirements, Crescent standards, and regulatory expectations.
• Generate COAs for intermediate material, Drug Substance/Drug Product and collaborate with QA to facilitate batch disposition
• Monitor CDMO/CTL stability studies, review of raw data and approval of stability summary reports
• Trend and evaluate stability data according to ICH in support of shelf life/expiry date assignment and extensions
• Schedule, chair and facilitate stability review board meetings in support of stability data evaluation and assignment of product shelf-life
• Schedule, chair and facilitate stability review board in support of stability data evaluation and assignment of product shelf-life
• Schedule, chair and facilitate specification review board in support of new product specification and revisions
• Provide QC oversight for OOS/OOT investigations, deviations, CAPAs, and change control
• Review and approve specific sections of vendor batch records and other required documentation
• Collaborate with partners, CDMOs/CTLs to transfer, methods for release and stability testing as needed according to phase appropriate approach
• Participate in the qualification, validation, and lifecycle management of analytical methods.
• Support authoring and review of Module 3 sections of regulatory submissions (IND/IMPD/BLA).
• Ensure strong data integrity practices and compliance with GMP, ICH, and global regulatory guidelines.
• Assist in the establishment of QC systems, SOPs, and processes suitable for a lean and scalable operation.
• Participate in internal and external cross-functional meetings as QC representative and manage program timelines
• Provide leadership, mentoring, and technical development within the QC function.

Education & Experience

• B.S. or M.S. in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Minimum 10 years of industry experience in biologics analytical development and QC.
• Deep expertise in method qualification, validation, and lifecycle management.
• Significant experience overseeing QC activities at CDMOs/CTLs.
• Strong understanding of GMP, data integrity principles, and ICH analytical guidelines (Q2, Q5, Q6, Q1E).
• Experience supporting Module 3 sections of regulatory submissions and interacting with health authorities.
• Experience with bioassay (Binding ELISA and Cell Based Potency (CBA) method development and life cycle management is a plus.
• Hands on experience using Microsoft Office, Veeva Vault QualityDoc, LIMS, and Statistical software such as GraphPad Prism, JMP.
• Demonstrated ability to lead QC operations in a small or virtual biotech environment.
• Strong communication, leadership, and cross‑functional collaboration 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; also, two, one-week company-wide shutdowns each year
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities

$160,000 - $200,000 a year

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

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.