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Cmc Manager Jobs (NOW HIRING)

Telix Pharmaceuticals (AMER)

OR

Facilitate, manage, and lead internal CMC project teams comprised of technical CMC SMEs, Supply Chain, Logistics, Validation, Quality, Clinical Ops, and Regulatory * Establish and maintain CMC ...

TekWissen LLC

CMC Writer

Paramus, NJ · On-site

$45 - $50/hr

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Job Title: CMC Writer Location: Paramus, New ...

Rho Inc

CMC Regulatory Strategist

$153K - $202K/yr

Manage scope of work, budget, and timelines for external vendors, including consultants and external CMC writers * Participate in business development activities, including assisting in the ...

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Cmc Manager information

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$61.4K

$102.5K

How much do cmc manager jobs pay per year?

As of Jul 13, 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 is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, which can offer salaries exceeding $150,000 annually. These roles often require extensive experience, leadership skills, and knowledge of regulatory compliance, often supported by advanced certifications like RAC (Regulatory Affairs Certification).

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 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 is a CMC position?

A CMC (Chemistry, Manufacturing, and Controls) manager is responsible for overseeing the development, manufacturing, and regulatory compliance of pharmaceutical products. They ensure that drug development processes meet quality standards and regulatory requirements, often working closely with cross-functional teams and regulatory agencies.

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 is a CMC manager?

A CMC manager, or Chemistry, Manufacturing, and Controls manager, oversees the development, manufacturing, and regulatory compliance of pharmaceutical products. They coordinate activities related to drug formulation, quality assurance, and documentation to ensure products meet industry standards and regulatory requirements. Strong knowledge of GMP guidelines and regulatory submissions is essential for this role.

What is the highest paying management job?

The highest paying management jobs are often executive roles such as Chief Executive Officer (CEO), Chief Financial Officer (CFO), or Chief Operating Officer (COO), with salaries frequently exceeding several hundred thousand dollars annually. These positions typically require extensive experience, leadership skills, and advanced degrees, and they often involve overseeing large organizations or divisions.

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
What cities are hiring for Cmc Manager jobs? Cities with the most Cmc Manager job openings:
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
Infographic showing various Cmc Manager job openings in the United States as of July 2026, with employment types broken down into 25% Internship, 1% As Needed, 59% Full Time, 10% Part Time, 2% Contract, and 3% Summer. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $61,351 per year, or $29.5 per hour.

CMC Program Lead

Telix Pharmaceuticals (AMER)

OR

Other

Re-posted 5 days ago

Job description

See Yourself at Telix

As the CMC Program Lead, you will play a critical role in ensuring successful development and manufacturing of the company's radiopharmaceutical assets.  Ensuring the effective execution of CMC strategies through the cross functional collaboration of internal and external partners. The CMC Program Lead will be responsible for coordinating and delivering CMC activities in line with project requirements and company goals for assigned CMC development programs (Precision Medicine Diagnostics or Therapeutics).

Key Accountabilities:

  • Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates from first-in- human testing phases to all later phases of development, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions
  • Represent the CMC team on the global matrix team for the assigned project/s
  • Facilitate, manage, and lead internal CMC project teams comprised of technical CMC SMEs, Supply Chain, Logistics, Validation, Quality, Clinical Ops, and Regulatory
  • Establish and maintain CMC project dashboards, timelines, and budgets for assigned projects
  • Track CMC deliverables, approve invoices, and ensure the CMC strategies and plans are incorporated into the overall project plans
  • Proactively outline CMC risks and mitigation strategies, and communicate risks and issues to project teams and senior management
  • Provide regular CMC updates to senior management on project status, timelines, risks, issues, KPIs, and forecasting for future project needs
  • Lead CDMO/CMO CMC vendor selection process in collaboration with Quality and CMC SMEs, and serve as a relationship lead
  • Partner closely with all key stakeholders of the internal Telix teams, including Global Product Development Leads, Global Brand Leads, and external CDMO/CMOs to develop and maintain integrated project plans to identify/communicate interdependencies as well as critical path activities for the project.
  • Develop global CMC program hand-offs to enable smooth transitions from development to commercial and lifecycle management
  • Facilitate team meetings using project management best practices/tools to drive cross-functional communication, timely and effective decision making, and successful execution of project objectives.
  • Organize and maintain CMC team communications including meeting agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategies.
  • Identify gaps in processes, then work with appropriate parties to develop and implement solutions.
  • Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable.

Education and Experience:

  • BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline required
  • 10+ years of relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience with 5+ years of CMC program/project management experience.
  • Experience in working with cross-functional teams, external partners and CDMOs required
  • Excellent communication, collaboration, and change management skills
  • Robust knowledge of FDA and global regulatory requirements. Also possesses a strong technical understanding of manufacturing, radiopharmaceuticals, and product/process development
  • Must have strong experience in MS Office suite applications and management software (e.g., SAP, MS Project, Smartsheet)
  • Strong foundational collaboration skills with experience working in a successful matrix managed environment.
  • Ability to demonstrate initiative, suggest improvements to current systems as well as establish new processes
  • Able to thrive in a highly dynamic, fast paced, continuously changing global environment with minimal oversight/direction.
  • Ability to travel to manage collaborations with global team members and CDMOs.

Key Capabilities:

  • Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
  • Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
  • Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
  • Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
  • Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
  • Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
  • Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
  • Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
  • Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
  • Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

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