CMC Project Manager

Scientific Search

Watertown (MA)

Remote

USD 83,000 - 124,000

Full time

2 days ago
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Job summary

Scientific Search is seeking an experienced CMC Project Manager for a remote, contract engagement lasting 3-6 months. The role supports technical teams across Chemistry, Manufacturing, and Controls with a focus on antibodies and proteins, coordinating activities with CDMOs and internal groups.

Requirements include a BS in Science/Engineering, 10+ years in biopharma, 3-5+ years PM experience, GMP knowledge, and PMP is a plus. Willingness to adapt across time zones is essential.

Qualifications

  • BS degree in Science, Engineering or related field.
  • 10+ years of relevant biopharma industry experience.
  • 3-5+ years PM experience in a technical role.
  • Working knowledge of small molecules and biologics process development, GMP manufacturing and QC testing.
  • PMP certification is a plus.

Responsibilities

  • Develop and maintain integrated project plans, timelines, and milestones trackers.
  • Coordinate project activities across Technical Operations, Process Development, Analytical Development, Quality, Regulatory, Supply Chain, and Manufacturing teams.
  • Monitor financial approval cadence and coordinate budget management within teams.
  • Coordinate CMC team meetings with CMC leads, incl. agendas and minutes.
  • Ensure effective cross-function and cross-project communications across internal teams.
  • Support technical leads with vendor management including contract review and negotiation, timeline management, and quarterly business review meetings.
  • Collaborate with finance to forecast and manage budget and quarterly accrual for tech ops activities.
  • Support tech ops with RFPs, contracts, POs and invoice approvals.

Skills

Project management
Cross-functional coordination
Biopharma knowledge
GMP awareness

Education

BS in Science/Engineering

Tools

MS Project
Excel

Job description

CMC Project Manager - Contract

Location: Remote
Duration: 3-6 months


An innovative, rapidly growing biotechnology company is seeking an experienced CMC Project Manager. This position will support technical teams and manage associated projects both in house and at CDMO's. The successful candidate will have a strong understanding of the functional operations of Chemistry, Manufacturing, and Controls with a focus on antibodies and proteins in general.


Responsibilities


  • Develop and maintain integrated project plans, timelines, and milestones trackers

  • Coordinate project activities across Technical Operations, Process Development, Analytical Development, Quality, Regulatory, Supply Chain, and Manufacturing teams

  • Monitor financial approval cadence closely and coordinate budget management within teams

  • Coordinate CMC team meetings coordinating with CMC leads, including assembly of agendas and meeting minutes

  • Ensure effective cross-function and cross-project communications in and out of internal development teams

  • Support technical leads with vendor management but not limited to contract review and negotiation, timeline management, and quarterly business review meetings.

  • Collaborate with finance to forecast and manage the budget and quarterly accrual for all tech ops activities

  • Support tech ops with Request for Proposal, contracts, POs and invoice approvals.


Requirements


  • B.S. degree is required in Science, Engineering or related field with at least 10+ years relevant industry experience in biopharma

  • A minimum of 3-5+ years project management experience as designated project manager or PM responsibilities as part of a technical role

  • Working knowledge of small molecules and biologics process development, analytical development, GMP manufacturing and quality control testing

  • PMP certification is a plus

  • Ability to accommodate flexible working hours to support business relationships in different time zones

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