CMC Operations Coordinator

2 weeks ago

Waltham, United States LHH Full time

Job Title: GMU CMC Operations Lead

Location: Waltham, MA (Local candidates only; Fully Onsite)

Department: Genomic Medicine Unit (GMU) CMC, Sanofi

About Us:

The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is at the forefront of innovation, responsible for drug development from molecule/pre-candidate to product approval. Our mission is to serve patients through groundbreaking developments in drug substance (DS), drug product (DP), and analytical development, as well as DS/DP clinical manufacturing. Join us in our pursuit to design state-of-the-art manufacturing processes that redefine industry standards.

Position Overview:

We are seeking a dynamic and motivated GMU CMC Operations Lead to provide operational support for our CMC organization. This role will simplify workflows, empower scientists, and enhance operational efficiency to help achieve critical deliverables. Based in Waltham, MA, the role involves fostering collaboration across teams, solving operational challenges, and ensuring seamless coordination between scientific and support functions.

Key Responsibilities:

  • Foster an inclusive, motivating work environment encouraging creativity, accountability, and collaboration.
  • Lead and support champion teams within GMU in Waltham.
  • Act as a liaison between support functions and scientific teams, facilitating cross-functional interactions.
  • Identify and resolve operational bottlenecks to enable scientific progress.
  • Manage office and lab consumables, including procurement, invoicing, and inventory management.
  • Collaborate with support functions (HSE, Real Estate, Workspace Experience, Scientific Services) to maintain lab operations.
  • Oversee compliance with Health, Safety, Environmental, and Legal regulations.
  • Coordinate disruptive activities (e.g., renovations, equipment installations) to minimize impact on scientific work.

Basic Qualifications:

  • Bachelor’s degree in Life Sciences or Engineering.
  • Minimum of 5 years of experience in research and development operations, including pharma R&D.
  • At least 2 years of management experience.
  • Strong understanding of safety principles, GXP commissioning practices, and regulated environments.
  • Operational experience in R&D and development laboratories.
  • Proficiency in Microsoft Office and tools like Concur, eBuy, EasyInvoice, and Workday.
  • Excellent communication, technical writing, and problem-solving skills.

Preferred Qualifications:

  • Master’s degree in Life Sciences.
  • Biologics/pharmaceutical facility startup and management experience.
  • Comprehensive knowledge of biotechnology processes and biologics manufacturing systems.
  • Exceptional leadership and change management skills.

Special Working Conditions:

  • Ability to gown and access laboratory, manufacturing, and mechanical areas.
  • Capacity to handle materials, receive deliveries, and operate pallet jacks as per HSE requirements.

Why Join Us?

This is an exciting opportunity to contribute to cutting-edge advancements in genomic medicine. You’ll work with a passionate, innovative team dedicated to improving patient outcomes through transformative science.

How to Apply:

If you meet the qualifications and are ready to take on this challenging and rewarding role, please submit your resume and cover letter.

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