Project Management Director for Combination Product Development

6 days ago


Waltham, Massachusetts, United States Apellis Full time
Job Description

Apellis is seeking a highly skilled Associate Director, Project Management to support the development and execution of project plans for Prefilled Syringe and Combination Product. This role will involve collaborating with cross-functional teams to drive deliverables, manage risks, and ensure timely project completion.

Key Responsibilities:

  • Lead project planning, risk management, and issue escalation to ensure successful project delivery.
  • Collaborate with project leaders and team members to create detailed project timelines and verify connectivity between activities.
  • Manage project milestones, deliverables, action items, and key interdependencies using experienced project management techniques.
  • Develop and maintain effective relationships with CDMO partners to meet project deliverables.
  • Organize meetings, develop agendas, take meeting minutes, track metrics, create reports, and dashboards for key stakeholders.

Requirements:

  • Bachelor's degree in science, engineering, healthcare, or business administration with prior project management experience.
  • 10+ years of experience in project management within the pharmaceutical or medical device industry.
  • Experience working in an ISO 13485 compliant quality management system.
  • Deep understanding of design controls and their application to combination product development.
  • Project management experience leading combination product development.

Skills and Abilities:

  • Highly organized, service-oriented, and adept at problem-solving.
  • Excellent written and verbal communication skills, with ability to communicate effectively with management and peers.
  • Ability to work independently with minimal supervision and navigate ambiguity.

Work Environment:

This is a sedentary role with some filing required. The ability to lift files and open filing cabinets is necessary.

Travel Requirements:

Expected travel to be 20%.

Benefits and Perks:

Apellis offers a great benefit package, including health insurance, 401K, paid time off, long-term disability insurance, and life insurance.



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