CMC Project manager Job at Sumeru Solutions, Remote

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  • Sumeru Solutions
  • Remote

Job Description

Project Details:

Job Title:

CMC Project Manager

Duration:

06+ Months

Client:

Cognizant

Location:

100% Remote

Job Summary:

We are seeking a highly skilled and detail-oriented CMC Project Manager (Chemistry, Manufacturing & Controls) with a strong background in pharmaceutical sciences, chemistry, or life sciences. The ideal candidate will lead cross-functional CMC activities to ensure timely development and delivery of drug substances and drug products aligned with regulatory and commercial goals.

Qualifications & Responsibilities:

  • Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related life sciences discipline.
  • 5+ years of experience in CMC project management within pharmaceutical or biotechnology industries.
  • Lead and manage end-to-end CMC project activities for preclinical, clinical, and commercial-stage drug products.
  • Ensure all CMC activities are conducted in compliance with GMP, ICH, and FDA/EMA regulations.
  • Collaborate closely with R&D, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external CDMOs/CMOs.
  • Track deliverables, milestones, risks, and mitigation strategies using standard project management tools (MS Project, Smartsheet, etc.).
  • Provide regular project updates to leadership and facilitate cross-functional meetings to resolve issues and align priorities.
  • Excellent organizational, communication, and leadership skills.
  • PMP certification or formal project management training is preferred.

Job Tags

Remote job,

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