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Cmc Operations Jobs in Massachusetts (NOW HIRING)

Madrigal

Director, Regulatory Affairs CMC

Waltham, MA · On-site

$200 - $250/hr

This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post‑approval submissions, and manages ...

Vrtx

CMC Statistics Director

Boston, MA · On-site

This individual will establish and lead the CMC Statistics capability, enabling data-driven decision-making to enhance product quality, process robustness, operational efficiency, and regulatory ...

AbbVie

Director, ADC CMC Sciences

Waltham, MA · On-site

Lead cross-functional S&T product teams and represent the CMC team and/or S&T in interface with S&T leadership, other Operations functions, other AbbVie functions and external partners. Participate ...

Moderna, Inc.

Director, CMC Product Lead

Norwood, MA · On-site

$183K - $330K/yr

The CMC Product Lead ensures seamless integration of program strategy with the Target Product ... operational impact. Here's What You'll Bring to the Table (Preferred Qualifications) * PhD in ...

RXinsider LTD.

Director, CMC Product Lead

Norwood, MA · On-site

$250/hr

The CMC Product Lead ensures seamless integration of program strategy with the Target Product ... operational impact. Here's What You'll Bring to the Table (Preferred Qualifications) * PhD in ...

New

AbbVie

Associate Director, RA CMC

Waltham, MA · On-site

Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development ...

AbbVie

Associate Director, RA CMC

Waltham, MA

Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development ...

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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:

What job categories do people searching Cmc Operations jobs in Massachusetts look for?

The top searched job categories for Cmc Operations jobs in Massachusetts are:

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Cities in Massachusetts with the most Cmc Operations job openings:

Cmc Operations jobs near you

Director, Regulatory Affairs CMC

Madrigal

Waltham, MA • On-site

$200 - $250/hr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 3 days ago

Job description

Overview

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction‑associated steatohepatitis (MASH). This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post‑approval submissions, and manages day‑to‑day regulatory CMC activities for assigned projects.

Key Responsibilities
  • Independently develop and lead execution of regulatory CMC investigational, registration and/or post‑approval strategies for assigned products.
  • Apply expert regulatory CMC knowledge to address and overcome challenges during development and commercialization.
  • Guide the team in defining and driving the strategy for CMC regulatory dossier content and review this content for conformance with Health Authority requirements.
  • Represent the Madrigal Regulatory CMC function in Health Authority meetings and drive preparation activities for those meetings.
  • Provide global regulatory input and support to quality‑related activities, including impact assessments for change controls, deviations and investigations.
  • Proactively identify regulatory CMC risks and communicate timely with line management.
  • Monitor, interpret and communicate relevant global regulatory requirements, guidelines and emerging trends.
Qualifications
  • BS in life sciences in a healthcare field or equivalent experience; advanced degree strongly preferred.
  • Minimum of 12 years relevant experience, including 8‑10 years regulatory CMC experience, with broad‑based CMC technical and product experience.
  • Strategic regulatory CMC experience with a proven track record in clinical, commercialization and life‑cycle management of small‑molecule products.
  • Demonstrated experience interacting with global Health Authorities on CMC topics.
  • Strong knowledge of regulations/guidelines governing global CMC development of pharmaceuticals.
  • Excellent communication and negotiation skills, able to effectively communicate with technical SMEs and present scientific cases to stakeholders and regulatory agencies.
Benefits
  • Competitive base salary (US$207,000–$253,000 per year) and bonus.
  • Equity participation for all employees.
  • Comprehensive benefits including flexible paid time off, medical, dental, vision and life/disability insurance.
  • 401(k) plans (traditional, Roth, employer match).
  • Additional voluntary benefits such as supplemental life insurance and legal services.
  • Mental health benefits through Employee Assistance Program.
Other Information

All full‑time employees are eligible for reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com.

Equal Opportunity Employer. Employment is decided on the basis of qualifications, merit, and business need, with consideration given without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran status or other characteristic protected by applicable federal or state law.

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