Project Manager – Chemistry Manufacturing and Control (CMC)

Project Manager – Chemistry Manufacturing and Control (CMC)

Job Description

The CMC Project Manager will support planning, tracking and communication of CMC activities to
both internal and external stakeholders and partners, including designated Contract Manufacturing
Organizations (CMOs). Facilitate CMC related meetings, maintain CMC project schedules and
ensure alignment with cross-functional integrated timelines.

Responsibilities

  • Utilize project management tools and best practices to support CMC activities
  • Document, track and communicate progress against CMC timelines, milestones and budgets
  • Assist with cross-functional project team meetings; issue agendas and minutes and track
    deliverables
  • Lead various scheduled and ad hoc CMC or CMC sub-team meetings
  • Facilitate problem-solving, risk management, contingency planning, and decision-making
  • Assist in the implementation of project related tasks

Requirements

  • MS in Chemistry/ Pharmacy/ Biological Sciences or similar
  • 3+ years of project management experience within the biotechnology or pharmaceutical
    industry; preferably within CMC
  • Familiarity with biological product development phases and regulatory requirements
  • Excellent english knowledge written and spoken
  • Good knowledge of Microsoft Office (Microsoft Word, Excel, Powerpoint)
  • Well organized and detail oriented
  • Ability to prioritize multiple tasks
  • Problem solving, decision making, negotiation and influencing capacity result orientation
  • Strong interpersonal and communication skills: active listening, effective message delivery,
    empathy, proactive attitude
  • Ability to motivate
  • Show strong attitude to leadership and communication

Other Qualifications

  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small company environment
  • Must be self-motivated, self-disciplined and able to function independently as well as part of a
    team
  • Excellent interpersonal skills, including the ability to influence and to work effectively crossfunctionally
  • Excellent presentation and written/verbal communication skills
  • Experience working with CMO’s/CTO’s highly desired
  • Experience with MS Project highly desired
  • Approximately 10% travel may be required

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