Associate Director Project Management CMC

Role Summary

The Associate Director will develop, communicate, and drive the execution of fully integrated, cross-functional drug manufacturing plans and timelines to meet commercial demand. Build strong partnerships across CMC, Supply Chain, Regulatory, Quality, R&D, Facilities and Commercial to advance milestones in alignment with company priorities. Regularly report project plans, schedules, and risk mitigation to Executive Leadership. The role empowers challenging the status quo and offering innovative solutions to maximize operational efficiencies in drug manufacturing.

• Manage and supervise CMC-focused project teams.
• Define and communicate team roles, scope, goals, and deliverables with senior management and stakeholders.
• Develop and execute integrated project plans and information management practices.
• Regularly challenge timelines and propose innovative approaches to minimize milestone delivery risks.
• Communicate project modifications and new responsibilities, deadlines, and target dates to impacted parties.
• Coordinate with Legal and Finance to ensure concurrence with budgetary, IP, and fiduciary requirements.
• Develop and implement procedures for project monitoring, including team meetings, daily stand-ups, action item follow-up, and meeting minutes.
• Manage workflow requirements and documentation related to projects.
• Interface with executives/department leads for strategy and budgeting purposes.
• Oversee External collaborations (CDMOs, CMOs, OTLs, etc.) and challenge delivery timelines.
• Maintain a system for problem resolution related to project scope, requirements, deadlines, etc.
• Drive resolution of project conflicts with strategic, executable solutions.
• Provide weekly project reports.
• Serve as Operations representative on internal teams and focus groups (e.g., Safety and Facilities Planning).

• B.S. / M.S. in Science, Biological Engineering or Biotechnology.
• Five (5) or more years of Manufacturing, CMC experience (preferably Biologics).
• Five (5) to seven (7) years CMC project management experience, or a combination of education and experience.
• Alliance Management with service providers (CMOs, CROs, research institutions, etc.).
• Strong experience with Pharma/Biotech on complex drug development programs.
• Program Management Professional (PgMP) or Project Management Professional (PMP) certification desirable.

• Independent, motivated to directly impact the manufacture of new medicines.
• Technical experience in drug manufacturing or engineering as SME or CMC project manager.
• Agile, able to pivot to changing business demands.
• Excellent interpersonal skills to lead, negotiate, resolve conflicts, and drive consensus.
• Mastery of technical scheduling, scenario planning, and reporting with tools like Microsoft Project or Smartsheet.
• Strong analytical thinking with planning, organization, and execution skills.
• Ability to identify, prioritize, and resolve key project and partnership issues.
• Ability to anticipate and solve problems in complex environments.
• High attention to detail and ability to manage multiple projects/priorities.
• Excellent oral and written communication skills; ability to convey complex concepts concisely.
• Ability to coordinate demands from multiple internal and external stakeholders.
• Strong prioritization and execution in a high-pressure, milestone-driven environment.

• As listed in Qualifications above.