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Cmc Program Manager Jobs in Winchester, MA (NOW HIRING)

Elektrofi

Senior Director, CMC Technical Lead

Boston, MA · On-site

$235K - $285K/yr

Join us as a Senior Director, CMC Technical Lead , and you'll be part of a culture that welcomes ... Partner with the program manager, functional heads, and technical SMEs to identify risks, and ...

Clinovo

Program Manager

Cambridge, MA · On-site

... CMC, Data Management, Quality, and other functional groups. * Facilitate recurring cross-functional ... Prepare and present program updates, status reports, and key metrics to senior leadership and ...

Artis BioSolutions

Senior Program Manager

Watertown, MA · On-site

$140K - $165K/yr

The Senior Program Manager has an in-depth understanding of the processes and systems required to ... The company provides CMC development and GMP manufacturing capabilities for cell and gene therapies ...

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Cmc Program Manager information

See Winchester, MA salary details

$40.8K

$113.9K

$166.4K

How much do cmc program manager jobs pay per year?

As of Aug 25, 2026, the average yearly pay for cmc program manager in Winchester, MA is $113,914.00, according to ZipRecruiter salary data. Most workers in this role earn between $84,300.00 and $140,500.00 per year, depending on experience, location, and employer.

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 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 job categories do people searching Cmc Program Manager jobs in Winchester, MA look for?

The top searched job categories for Cmc Program Manager jobs in Winchester, MA are:

What cities near Winchester, MA are hiring for Cmc Program Manager jobs?

Cities near Winchester, MA with the most Cmc Program Manager job openings:

Cmc Program Manager jobs near you
Infographic showing various Cmc Program Manager job openings in Winchester, MA as of August 2026, with employment types broken down into 1% As Needed, 74% Full Time, 20% Part Time, 1% Temporary, and 4% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $113,914 per year, or $54.8 per hour.

Associate/Sr. Associate - CMC Project Management & Operations

Waltham, MA • On-site

Oruka Therapeutics
See more jobs at Oruka Therapeuticsexternal

Full-time

Re-posted 19 days ago

Job description

About Us:
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Associate/Sr. Associate - CMC Project Management and OperationsLocation: Waltham, MA Hybrid - onsite 3 days/week required
Reports to: CMC Program Manager
Position Overview:We are seeking a highly motivated Associate/Sr. Associate to join our dynamic growing team as we work to set a new standard in treating chronic skin diseases. This role will be pivotal in developing and managing systems to support critical CMC projects, driving the success of our clinical stage programs. This role reports to the CMC Program Manager.
The ideal candidate will have strong written and verbal communication skills and enjoy working with cross-functional teams and stakeholders. They should be highly organized, able to manage multiple priorities, and comfortable working in a fast-paced environment. Some experience in drug development, manufacturing, CMC, or a related scientific field is preferred. The successful candidate will be proactive, detail-oriented, and eager to learn and contribute across a range of activities.
Our team values in-person collaboration, and we expect this role to work from our Waltham office three days per week. We're looking for someone who shares our passion for developing innovative medicines and is eager to make a meaningful impact.
Key Responsibilities
  • Support CMC program execution by assisting the CMC Program Manager with day-to-day coordination of late-stage manufacturing, process development, analytical, quality, and regulatory readiness activities.
  • Manage CMC documentation workflows, including drafting support, formatting, version control, review routing, comment resolution tracking, approvals, and archival of key program documents.
  • Maintain integrated CMC trackers and timelines for deliverables such as batch records, protocols, reports, specifications, comparability documentation, stability updates, regulatory content, and manufacturing readiness milestones.
  • Prepare meeting materials and outputs, including agendas, decision logs, action-item trackers, meeting minutes, dashboards, and follow-up communications for CMC team meetings and governance reviews.
  • Track risks, issues, decisions, and dependencies across CMC workstreams and escalate delays, gaps, or cross-functional misalignments to the CMC Program Manager.
  • Support external partner and CDMO coordination by managing document exchanges, action trackers, meeting follow-ups, deliverable status updates, and communication records.
  • Contribute to continuous improvement of CMC project management tools and processes, including templates, trackers, document control practices, reporting formats, and readiness checklists.

Qualifications:
  • Master's degree in life sciences, engineering, pharmaceutical sciences, biotechnology or a related discipline with 0-2 years relevant experience, or Bachelor's degree with 2-4 years of relevant experience.
  • Experience in a biopharmaceutical, biotechnology, or regulated drug development environment is required.
  • Experience in manufacturing, drug development, process development, analytical or other CMC-related functions is preferred.
  • Strong organizational skills with the ability to manage multiple priorities, track deliverables, maintain timelines, and follow up on action items.
  • Excellent written and oral communication skills, with the ability to prepare clear meeting summaries, trackers and cross-functional messages.
  • Ability to work independently while knowing when to escalate risks, issues or delays.
  • Proficiency with standard business and project-management tools, such as Microsoft Office, Sharepoint, Smartsheet or similar systems.
  • Ability to operate in a fast-paced, timeline-driven environment and adapt to changing program priorities.
  • Basic understanding of regulated documentation practices, GMP concepts or CMC development workflows is preferred.

Compensation:
  • An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
  • The anticipated salary range for candidates in Waltham, MA for Associate level is $104,000 - $125,000 and for Sr. Associate is $130,000 - $146,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.

Location: Waltham, MA Hybrid - onsite 3 days/week required
Salary Range for the Role
$104,000-$146,000 USD
What We Offer:
  • A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
  • Competitive salary and benefits package.
  • A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
  • Opportunities for professional growth and development.

Apply