Executive Director, Biologics CMC

Crescent Biopharma•Waltham, MA

2d•$226,000 - $250,000

About The Position

Crescent Biopharma is seeking a highly accomplished CMC executive to lead biologics CMC strategy and external manufacturing operations across a growing portfolio of innovative biologic programs. You will serve as the Executive Director and CMC lead, providing strategic, technical, and operational oversight for end-to-end product development from early-stage development through commercialization. You will bring deep expertise in downstream purification and process robustness, including chromatography development, filtration strategies, viral clearance, process characterization, PPQ readiness, and lifecycle management across all phases of development.

Requirements

Ph.D. or M.S. in Biochemistry, Chemical Engineering, Biotechnology, or related field.
Minimum 15+ years of industry experience in biologics process development, CMC leadership and GMP manufacturing, including extensive CDMO oversight.
Demonstrated executive-level leadership experience advancing biologics programs from early development through commercialization.
Deep expertise in downstream purification and commercial manufacturing of biologics; experience with upstream, formulation, and fill-finish operations is highly desirable.
Extensive experience in late-stage and commercial manufacturing, including PC, PPQ, PAI readiness and lifecycle management.
Demonstrated ability to lead CMC strategy and operations in a small or virtual biotech setting.
Comprehensive knowledge of GMP, ICH guidelines, and regulatory expectations for biologics.
Excellent communication, organizational, and problem-solving abilities.

Nice To Haves

experience with upstream, formulation, and fill-finish operations is highly desirable.

Responsibilities

Provide deep technical leadership in downstream purification operations, including chromatography (capture, intermediate, and polishing), filtration, and UF/DF.
Lead downstream process characterization, scale-up strategy, resin lifetime studies, and impurity clearance evaluations.
Troubleshoot purification performance issues such as aggregation, low yield, impurity breakthrough, or filtration bottlenecks.
Provide overall CMC leadership for assigned biologics programs, including bsAb and ADC molecules, from development through clinical and commercial manufacturing.
Oversee CDMO activities and serve as the primary technical and strategic interface between internal teams and external partners.
Deliver expert guidance on purification process design, optimization, and troubleshooting to ensure robust, scalable processes.
Monitor process development, MSAT, and manufacturing timelines to ensure timely, high-quality execution aligned with program goals and budgets.
Manage CDMO performance and proactively address technical or operational issues.
Coordinate with Quality, Regulatory, and Clinical functions to align CMC activities with development and regulatory strategies.
Prepare and review CMC sections of regulatory submissions (IND/IMPD/BLA).
Promote continuous improvement and ensure adherence to GMP, data integrity, and compliance requirements.
Support budgeting, vendor selection, and contract oversight for external manufacturing activities.
Provide technical leadership within a lean, collaborative team environment.

Benefits

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
medical, dental, vision, life insurance, short- and long-term disability
Company’s savings plan (401(k))
Company’s long-term incentive program
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