Associate Director Project Management CMC

Role Summary

Associate Director will be accountable for developing, communicating and driving the execution of fully integrated and cross functional drug manufacturing plans and timelines to meet commercial demand. Build partnerships across CMC, Supply Chain, Regulatory, Quality, R&D, Facilities, and Commercial to advance milestones. Regular reporting to Executive Leadership on project plans, schedules, and risk mitigation approaches.

Responsibilities

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

Qualifications

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

Skills

• Independent, motivated to directly impact manufacture of new medicines for patients.
• Technical experience in drug manufacturing or engineering as SME or CMC project manager.
• Agile and able to pivot to changing business demands.
• Excellent interpersonal skills to lead, negotiate, resolve conflict and drive consensus.
• Mastery in technical scheduling, scenario planning and reporting (MS 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.
• Attention to detail and excellence in project management with multiple priorities.
• Strong oral and written communication; ability to convey complex concepts concisely.
• Experience coordinating demands from multiple internal and external stakeholders.
• Ability to prioritize and execute in a high-pressure, milestone-driven, rapidly changing environment.
• High ethical standards and trustworthiness.

Education

• B.S./M.S. in Science, Biological Engineering or Biotechnology.