Manager, CMC Project Management

Crescent Biopharma•Waltham, MA

2d•$140,000 - $180,000•Onsite

About The Position

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. We are seeking a Manager, CMC Project Management who is responsible for driving cross-functional execution of CMC activities in support of early and late-stage clinical development programs. Working closely with Technical Operations - including Drug Substance, Drug Product, Analytical Development, Regulatory CMC, Quality, Supply Chain and external partners, this role leads integrated project planning, facilitates cross-functional alignment, manages risks and timelines, and enables successful delivery of CMC milestones in support of regulatory and development objectives. This role is based in Waltham, MA and you must have experience in the oncology space.

Requirements

Bachelor’s degree in a scientific, engineering, or related discipline required.
5–8 years of biotech or pharmaceutical industry experience.
Experience in CMC, Technical Operations, Project Management, Manufacturing, Supply Chain, or related functions.
Familiarity with GMP manufacturing and external partner management.
Strong project management and organizational skills.
Ability to manage multiple priorities in a fast-paced environment.
Excellent communication and collaboration skills.
Experience with project planning and tracking tools.
Ability to identify risks and drive issue resolution.
Detail-oriented with strong follow-through and accountability

Nice To Haves

Experience in the oncology space.

Responsibilities

Lead cross-functional CMC project management for clinical-stage development programs, developing and maintaining integrated project plans, timelines, critical path activities, milestones, risks, and decision logs.
Drive project execution by facilitating cross-functional meetings, tracking actions and decisions, proactively identifying risks and dependencies, and escalating issues to ensure program objectives are achieved.
Coordinate activities across Drug Substance, Drug Product, Analytical Development, Quality Control, Quality Assurance, Supply Chain, Regulatory CMC, and other Technical Operations functions to ensure alignment of priorities and deliverables
Partner with CDMOs, CROs, testing laboratories, and other external vendors to monitor deliverables, manufacturing activities, timelines, and issue resolution.
Coordinate planning and execution of CMC regulatory submissions, including INDs, IMPDs, amendments, and health authority responses, ensuring cross-functional deliverables are completed on schedule.
Support program budgeting, forecasting, resource planning, purchase order tracking, and financial reporting to enable effective execution of CMC development activities.
Identify and implement process improvements to strengthen CMC project execution, governance, resource planning, and organizational effectiveness.

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