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US Tech Solutions

CMC Manager

Morristown, NJ · On-site

CMC Manager Location: 36 Columbia Rd., Morristown, NJ, USA, 07962 Duration: 12+ Months This position will support the Morristown CMCD team. The CMCD team is responsible for providing technical ...

Us tech Solutions

CMC Regulatory Manager

Morristown, NJ · On-site

CMC Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control (Module 3) documentation for the ...

Olema Oncology

Program Manager, CMC

San Francisco, CA · On-site

About the Role >>> Program Manager, CMC As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical ...

Olema Oncology

Program Manager, CMC

Boston, MA · On-site

About the Role >>> Program Manager, CMC As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical ...

Olema Oncology

Program Manager, CMC

San Francisco, CA · On-site

About the Role >>> Program Manager, CMC As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical ...

Olema Oncology

Program Manager, CMC

Boston, MA · On-site

About the Role >>> Program Manager, CMC As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical ...

BioTech Rec

Description Project Manager - CMC Contract - 12 - 18 months Our client is a clinical stage biopharma company focusing on rare diseases. They have a product which has positive results from clinical ...

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$61.4K

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How much do cmc manager jobs pay per year?

As of May 29, 2026, the average yearly pay for cmc manager in the United States is $61,351.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $69,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a CMC Manager, and why are they important?

To thrive as a CMC Manager, you need expertise in chemistry, manufacturing, and controls (CMC) regulations, drug development processes, and a relevant scientific degree, often with experience in the pharmaceutical or biotechnology industry. Familiarity with regulatory submission systems, quality management software, and documentation tools such as eCTD is typically required. Strong project management, leadership, and cross-functional communication skills help coordinate teams and manage complex timelines. These competencies are vital for ensuring regulatory compliance, efficient product development, and successful market approval.

What are some common challenges a CMC Manager faces when coordinating cross-functional teams during drug development?

A CMC Manager often navigates complex challenges such as aligning timelines and priorities between research, manufacturing, quality assurance, and regulatory teams. Ensuring effective communication and data transfer across departments is crucial, especially when dealing with global teams or external partners. Additionally, adapting to evolving regulatory requirements and managing resource constraints while maintaining project momentum are frequent hurdles. Success in this role relies on strong project management, problem-solving skills, and the ability to build collaborative relationships across diverse functional areas.

What are CMC Managers?

CMC Managers, or Chemistry, Manufacturing, and Controls Managers, are professionals responsible for overseeing the development, production, and quality control processes of pharmaceutical products. They ensure that all aspects of drug manufacturing comply with regulatory standards and that the product is safe, effective, and consistent. CMC Managers coordinate between research, development, regulatory affairs, and production teams to streamline processes and solve technical issues. Their work is crucial for securing regulatory approval and bringing medicines to market efficiently.

What is the difference between Cmc Manager vs Cmc Specialist?

AspectCmc ManagerCmc Specialist
CredentialsBachelor's or Master's in Life Sciences, Chemistry, or related field; often requires industry certificationsSimilar educational background; certifications may enhance prospects
Work EnvironmentOversees teams, manages projects, liaises with regulatory agenciesExecutes specific tasks within projects, supports Cmc managers
ResponsibilitiesStrategic planning, team leadership, regulatory submissionsData compilation, documentation, technical support

The Cmc Manager typically holds a leadership role, overseeing Cmc specialists and managing regulatory processes, while the Cmc Specialist focuses on technical execution and documentation. Both roles require similar educational backgrounds and industry experience, but differ mainly in scope and responsibility.

More about Cmc Manager jobs
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What are the most commonly searched types of Cmc jobs? The most popular types of Cmc jobs are:
What states have the most Cmc Manager jobs? States with the most job openings for Cmc Manager jobs include:
Cmc Manager jobs near you
CMC Manager, Adjuvant

CMC Manager, Adjuvant

Taylor Strategy Partners

Bothell, WA • On-site

$155K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 8 days ago

Job description

Description
CMC MANAGER , ADJUVANT
PURPOSE
The CMC Manager is responsible for managing CMC activities, ensuring compliance with regulatory standards , and aligning with project goals. This role involves managing an adjuvant drug product from late-phase development through cGMP production and BLA-enabling studies, while maintaining adherence to regulatory guidelines. The Manager is expected to coordinate timelines, budgets, resources, and multi-functional teams to achieve project goals.
KEY ROLES AND RESPONSIBILITIES
  • Manage an adjuvant drug product in late-phase development.
  • Provide specialized knowledge in certain areas of expertise, such as emulsification or fill/finish.
  • Maintain adherence to regulatory guidelines and standards for all CMC processes.
  • Review and approval of CMC documents, such as protocols, reports, batch records, etc.
  • Author internal documentation, such as process documentation, SOP's, and supporting quality events.
  • Support regulatory documentation drafting as needed.
  • Manage internal CMC data sets.
  • Analyze process data and trends using scientific and engineering principles. Coordinate timelines, budgets, resources, and multi-functional teams to achieve project goals.
  • Collaborate with cross-functional teams to resolve CMC-related technical challenges.
  • Mentor and develop junior CMC staff.
  • Support other CMC activities as needed.

REQUIRED QUALIFICATIONS
  • BA/BS degree in science, engineering, or related field.
  • 4+ years of work experience in CMC or related field.

PREFERRED QUALIFICATIONS
  • MS degree in science , engineering, or related field.
  • Prior experience developing, scaling, or manufacturing complex drug product systems, such as oil-in-water emulsions/ nano emulsions , and/or related lipid-based delivery systems, such as LNPs/liposomes.
  • Prior experience supporting sterile drug product fill/finish, including aseptic processing, visual inspection, and primary packaging.
  • Prior experience with process validation and technology transfers.

KNOWLEDGE, SKILLS, AND ABILITIES
  • Strong understanding of CMC processes and regulatory requirements.
  • Experience in pharmaceutical development and manufacturing.
  • Knowledge of US, EU regulations and guidelines, and application of GMPs.
  • Strong organizational and project management skills.
  • Strong technical skills, including statistical analysis, to overcome technical challenges.
  • Excellent communication and collaboration skills.
  • Ability to manage multiple tasks and projects simultaneously.

PHYSICAL DEMANDS
Performing the responsibilities of the job requires the ability to use hands and fingers to handle or feel and to manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop , kneel, crouch, or crawl. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Vision abilities required by this job include close vision. May occasionally have to lift, tug, and pull up to 25 lbs.
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment , including computers, phones, photocopiers, filing cabinets, and fax machines.
Curevo offers its employees a generous range of compensation and benefits.
The salary range for this position is $ 145,000 - $155,000 annually. The salary range may vary based on Curevo's compensation practices and an applicant's qualifications and experience.
Employees have the opportunity to earn an Annual Discretionary Bonus, as well as being eligible to participate in Curevo's Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect. We have a Flexible Vacation Plan, a Paid Sick Leave Plan, and earn 1 hour of sick time for every 30 hours worked, plus 10 paid holidays per year.
At Curevo, we believe the highest-performing teams include people from diverse backgrounds and experiences who respectfully challenge one another and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Curevo is proud to be an equal opportunity employer and does not discriminate based on race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.
About Curevo Vaccine
Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.
Attention: Search Firms / 3rd Party Recruitment Agencies
The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered the property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated with hiring from unsolicited resumes.
Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions.

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