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Cmc Program Manager Jobs in Massachusetts (NOW HIRING)

Rhythm Pharmaceuticals

Director, Regulatory CMC

Boston, MA · On-site

$182K - $275K/yr

... programs. As part of the growing and dynamic regulatory affairs team, this role is accountable for the effective management and timely delivery of CMC regulatory documents, coordination of cross ...

Syner-G

Sr. Consultant

Framingham, MA

Lead and manage CMC development activities for drug substances and drug products, ensuring alignment with program objectives and regulatory requirements. * Oversee CDMO/CMO selection, qualification ...

Moderna, Inc.

Director, CMC Stability

Norwood, MA · On-site

... clinical, and commercial programs. This leader will translate target product profile (TPP ... management. This is an onsite role based in Moderna's Technology Center campus in Norwood, MA. In ...

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Cmc Program Manager information

What is the difference between Cmc Program Manager vs Cmc Project Manager?

AspectCmc Program ManagerCmc Project Manager
CredentialsTypically requires a Bachelor's degree in life sciences, engineering, or related field; often certifications like PMP or PgMPUsually holds a Bachelor's degree in a relevant field; PMP certification is common
Work EnvironmentOversees multiple projects within a program, coordinating cross-project activities in biotech or pharma industriesManages individual projects, focusing on specific deliverables within the CMC scope
Employer & IndustryPharmaceutical, biotech, or life sciences companies managing complex product developmentSimilar industry, often within the same companies, focusing on specific project execution

The Cmc Program Manager oversees multiple related projects, ensuring alignment with strategic goals, while the Cmc Project Manager focuses on executing individual projects within the CMC domain. Both roles require similar credentials and work in the same industry, but differ in scope and responsibilities.

What is a CMC Program Manager?

CMC Program Managers are professionals responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical or biotechnology product development. They coordinate cross-functional teams to ensure that drug development activities related to product formulation, manufacturing, quality, and regulatory submissions are completed on time and within budget. Their role is crucial in advancing products through clinical development to commercialization while ensuring compliance with global regulatory requirements.

What are the key skills and qualifications needed to thrive as a CMC Program Manager?

To thrive as a CMC Program Manager, you need expertise in chemistry, manufacturing, and controls (CMC), project management experience, and an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems, quality management tools, and certifications such as PMP or Six Sigma are highly valued. Strong leadership, cross-functional communication, and problem-solving skills help manage diverse teams and complex projects effectively. These skills ensure the successful development, regulatory compliance, and timely delivery of pharmaceutical products.

What are some typical challenges a CMC Program Manager faces when coordinating cross-functional teams?

A CMC Program Manager often encounters challenges in aligning the goals and timelines of diverse teams such as process development, analytical, regulatory, and manufacturing. Communication gaps and shifting priorities can complicate project execution, especially when managing external partners or contract manufacturing organizations. Proactive stakeholder engagement and clear documentation are essential to ensure that everyone remains on track and regulatory requirements are met. Successfully navigating these complexities is key to advancing products efficiently through the development pipeline.
What are popular job titles related to Cmc Program Manager jobs in Massachusetts? For Cmc Program Manager jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Cmc Program Manager jobs in Massachusetts look for? The top searched job categories for Cmc Program Manager jobs in Massachusetts are:
What cities in Massachusetts are hiring for Cmc Program Manager jobs? Cities in Massachusetts with the most Cmc Program Manager job openings:
Cmc Program Manager jobs near you
Infographic showing various Cmc Program Manager job openings in Massachusetts as of August 2026, with employment types broken down into 97% Full Time, and 3% Part Time. Highlights an 100% In-person job distribution.

Director, Regulatory CMC

Rhythm Pharmaceuticals

Boston, MA • On-site

$182K - $275K/yr

Full-time

Posted 17 days ago

Job description

Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
This role is responsible for executing high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in alignment with strategies established by Global Regulatory Affairs and Technical Operations.
This individual contributor role will execute regulatory CMC plans and support implementation of filing strategies for assigned programs. As part of the growing and dynamic regulatory affairs team, this role is accountable for the effective management and timely delivery of CMC regulatory documents, coordination of cross-functional inputs, and support of regulatory CMC execution activities across development, commercialization, and lifecycle management. The role will work closely with Global Regulatory Affairs, Technical Operations, Quality, and other internal stakeholders to ensure deliverables are aligned, complete, and compliant with global regulatory requirements and commitments.
Responsibilities and Duties
  • Serve as the regulatory CMC representative on cross-functional teams for assigned programs and execute deliverables in alignment with strategies established by Global Regulatory Affairs and Technical Operations.
  • Author, compile, review, and finalize high-quality CMC regulatory documents and submissions, including core dossiers, INDs, IMPDs, MAAs, BLAs, variations, and annual reports, in collaboration with internal and external stakeholders.
  • Coordinate and support the timely execution of regulatory filings and submission activities in compliance with applicable global regulatory requirements, commitments, and internal timelines.
  • Prepare regulatory CMC meeting requests, briefing materials, and supporting documentation to enable effective health authority interactions and internal governance reviews.
  • Assess CMC change controls to determine regulatory impact, identify filing requirements across regions, evaluate supporting documentation, and escalate risks or gaps as appropriate.
  • Track regulatory commitments, health authority questions, and submission-related action items, and coordinate cross-functional responses within agreed timelines.
  • Maintain current knowledge of relevant CMC regulations, guidance, and regional expectations, and communicate executional impact to internal stakeholders.
  • Contribute to continuous improvement of regulatory processes, templates, SOPs, and systems that support efficient and compliant document development and submission execution.

Qualifications and Skills
  • A minimum of a B.S. degree in a scientific or life sciences discipline with a minimum of 10 years experience in Regulatory CMC, manufacturing, analytical development, quality, or related pharmaceutical development environments.
  • Demonstrated experience supporting regulatory programs for products intended to treat rare diseases and/or conditions with high unmet medical need is preferred.
  • Experience preparing CMC documentation to support clinical trial applications, marketing applications, post-approval submissions, and health authority responses.
  • Experience with peptides and injectable dosage forms and/or injection drug delivery devices is required.
  • Strong execution skills with demonstrated ability to manage multiple deliverables, coordinate cross-functional input, and deliver high-quality work within aggressive timelines.
  • Working knowledge of global CMC regulatory requirements, guidelines, and expectations across development, registration, and lifecycle management in multiple ICH regions.
  • Ability to work independently within established strategic direction, identify issues proactively, and escalate risks appropriately.
  • Strong organizational, planning, communication, and collaboration skills, with the ability to work effectively across Global Regulatory Affairs, Technical Operations, Quality, and external partners.

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $182,000 - $275,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
  • We are committed to advancing scientific understanding to improve patients' lives
  • We are inspired to tackle tough challenges and have the courage to ask bold questions
  • We are eager to learn and adapt
  • We believe collaboration and ownership are foundational for our success
  • We value the unique contribution each individual brings to furthering our mission

Inherent in our core values is the commitment to act ethically and with integrity in all we do.
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.

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