Manager, CMC Project Management

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.
Couple 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.

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.
• Able to manage multiple priorities in a fast-paced environment.
• Excellent communication and collaboration skills.
• Experience with project planning and tracking tools.
• Able to identify risks and drive issue resolution.
• Detail-oriented with strong follow-through and accountability.

Qualifications

• Experience in the oncology space preferred.

Skills

• Project Management
• Technical Operations
• CMC
• Manufacturing
• Supply Chain

Benefits

• 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.
• Savings plan (401(k)).
• Long-term incentive program.
• 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.

Pay

$140,000 - $180,000 a year

Schedule

Full-time

Company

Crescent Biopharma