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Cmc Operations Jobs in Massachusetts (NOW HIRING)

Alira Health

The Senior Director, Clinical Operations provides oversight of Clinical Development Operations, Nonclinical Development, Regulatory Affairs, Quality Assurance, Manufacturing/CMC Operations, and ...

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Cmc Operations information

What is the difference between Cmc Operations vs CMC Regulatory Affairs?

AspectCmc OperationsCMC Regulatory Affairs
Required CredentialsBachelor's degree in life sciences, engineering, or related field; experience in manufacturing or quality controlDegree in life sciences, pharmacy, or related; regulatory certifications often preferred
Work EnvironmentManufacturing plants, quality control labs, supply chainRegulatory agencies, corporate offices, compliance teams
Industry UsageManufacturing, quality assurance, supply chain managementRegulatory submissions, compliance, documentation
Common Search/ComparisonYesYes

While both Cmc Operations and CMC Regulatory Affairs are essential in the pharmaceutical industry, Cmc Operations focuses on manufacturing, quality control, and supply chain processes. In contrast, CMC Regulatory Affairs handles regulatory submissions, compliance, and documentation to ensure products meet legal standards. Understanding these differences helps professionals and employers align roles with their expertise and industry needs.

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For Cmc Operations jobs in Massachusetts, the most frequently searched job titles are:

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Cmc Operations jobs near you

Associate II, CMC Operations

Kailera Therapeutics, Inc.

Waltham, MA

Full-time

Posted 16 days ago

Job description

What You'll Do:

Reporting to the Associate Director, CMC Operations, the Associate II, CMC Operations will support the flawless execution of Kailera's analytical CMC program management activities. The individual will collaborate with CMC core team representatives and bridge cross-functional CMC sub-teams to manage all analytical activities and timelines for Kailera's multiple development projects.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

  • Participate in vendor meetings and track and manage analytical documents and deliverables
  • Support analytical CMC activities by tracking and monitoring vendor progress to ensure all work is occurring according to the contracted scope and schedule; work closely with analytical team to ensure invoices are submitted accurately
  • Assist with CMC analytical program budget by reviewing contract progress and scope and alerting the appropriate analytical teams of potential contract changes not captured in the current agreed to contracts
  • Support the Associate Director, CMC Operations by maintaining and updating appropriate CMC tracking tools, proactively communicating key issues and other critical topics, and escalating concerns in a timely manner
  • Assists in managing relationships and communication between Kailera and external partners or service providers as required

Required Qualifications:

  • 2-5 years of experience in pharmaceutical drug development and track record of success supporting multiple projects or programs simultaneously
  • Excellent communication skills
  • Proven track record of creativity, problem solving, and productivity
  • Demonstrated success working in interdisciplinary and cross-functional teams
  • Comfortable working in a dynamic, interactive, fast-paced, and entrepreneurial environment

Education:

  • Bachelor's degree
    • scientific discipline preferred

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