CMC Project Manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...
CMC Project Manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...
Senior Associate, CMC Regulatory
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The Position The Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality ...
Senior Associate, CMC Regulatory
Verona, WI · On-site
The Position The Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality ...
Senior Associate, CMC Regulatory
Madison, WI · On-site
The Position The Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality ...
New
Quick apply
Senior Associate, CMC Regulatory
Madison, WI · On-site
The Position The Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality ...
New
The Position The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change control and post-approval activities. Supporting diverse modalities-including small ...
The Position The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change control and post-approval activities. Supporting diverse modalities-including small ...
The Position The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change control and post-approval activities. Supporting diverse modalities--including small ...
Quick apply
The Position The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change control and post-approval activities. Supporting diverse modalities--including small ...
Global Head, Vaccine Chemistry, Manufacturing and Controls (CMC), Center for Vaccine Innovation a...
The Global Head of CMC provides leadership and management, operational excellence, and technical expertise to all CMC & NT activities within the CVIA portfolio of vaccine candidates and projects ...
Global Head, Vaccine Chemistry, Manufacturing and Controls (CMC), Center for Vaccine Innovation a...
The Global Head of CMC provides leadership and management, operational excellence, and technical expertise to all CMC & NT activities within the CVIA portfolio of vaccine candidates and projects ...
This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is ...
This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is ...
This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is ...
Quick apply
This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is ...
This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is ...
This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is ...
This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is ...
Quick apply
This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is ...
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$150K - $165K/yr
The Position We are seeking a Senior Manager, CMC Process Development on our Late Phase Development team to lead the strategy and execution of raw material manufacturing, regulatory classification ...
Posted today
Quick apply
Senior Manager, CMC Process Development
Madison, WI · On-site
$150K - $165K/yr
The Position We are seeking a Senior Manager, CMC Process Development on our Late Phase Development team to lead the strategy and execution of raw material manufacturing, regulatory classification ...
Posted today
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The Position A Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase ...
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Scientist I, CMC Process Development
Madison, WI · On-site
$85K - $95K/yr
The Position A Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase ...
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$85K - $95K/yr
The Position A Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase ...
Scientist I, CMC Process Development
Verona, WI · On-site
$85K - $95K/yr
The Position A Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase ...
Senior Scientist I, CMC Process Development
$115K - $140K/yr
The Position A Senior Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase ...
Quick apply
Senior Scientist I, CMC Process Development
$115K - $140K/yr
The Position A Senior Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase ...
Senior Scientist I, CMC Process Development
Verona, WI · On-site
$115K - $140K/yr
The Position A Senior Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase ...
Senior Scientist I, CMC Process Development
Verona, WI · On-site
$115K - $140K/yr
The Position A Senior Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase ...
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Verona, WI · On-site
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Associate Scientist III, CMC Analytical Development
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The Position This position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. An Associate Scientist III will support method development/validation activities for ...
Associate Scientist I, CMC Analytical Development
Verona, WI · On-site
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The Position The Associate Scientist I will join the CMC Analytical Development. This role supports analytical testing for drug substance and drug product development. The individual will perform ...
New
Associate Scientist I, CMC Analytical Development
Verona, WI · On-site
$57K - $68K/yr
The Position The Associate Scientist I will join the CMC Analytical Development. This role supports analytical testing for drug substance and drug product development. The individual will perform ...
New
Associate Scientist III, CMC Analytical Development
Madison, WI · On-site
$78K - $90K/yr
The Position This position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. An Associate Scientist III will support method development/validation activities for ...
Quick apply
Associate Scientist III, CMC Analytical Development
Madison, WI · On-site
$78K - $90K/yr
The Position This position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. An Associate Scientist III will support method development/validation activities for ...
The Position The Associate Scientist I will join the CMC Analytical Development. This role supports analytical testing for drug substance and drug product development. The individual will perform ...
Posted today
Quick apply
The Position The Associate Scientist I will join the CMC Analytical Development. This role supports analytical testing for drug substance and drug product development. The individual will perform ...
Posted today
Detailer
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$15 - $18/hr
At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills and offices that make us who we are as a company. Our success comes from finding ...
New
Detailer
Waukesha, WI · On-site
$15 - $18/hr
At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills and offices that make us who we are as a company. Our success comes from finding ...
New
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How much do cmc jobs pay per hour?
What are the key skills and qualifications needed to thrive as a CMC professional, and why are they important?
What are some common challenges faced by a CMC professional when coordinating between R&D, manufacturing, and regulatory teams?
What is a CMC?
What is the difference between CMC vs Regulatory Affairs Specialist?
| Aspect | CMC | Regulatory Affairs Specialist |
|---|---|---|
| Required Credentials | Bachelor's degree in life sciences, chemistry, or pharmacy; often additional certifications in pharmaceutical sciences | Bachelor's degree in life sciences, pharmacy, or related field; certifications in regulatory affairs are common |
| Work Environment | Laboratories, manufacturing sites, and R&D departments within pharmaceutical companies | Regulatory agencies, pharmaceutical companies, and consulting firms |
| Industry Usage | Focuses on drug development, manufacturing, and quality documentation | Focuses on compliance, submissions, and communication with regulatory bodies |
While both CMC and Regulatory Affairs Specialists work within the pharmaceutical industry, CMC professionals primarily handle the chemistry, manufacturing, and control aspects of drug development. Regulatory Affairs Specialists focus on ensuring compliance with regulations and managing submissions to authorities. Both roles often collaborate but serve distinct functions in bringing a drug to market.

Full-time
Medical, Dental, Vision, Life, Retirement
Posted 18 days ago
Job description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
We are currently seeking a CMC Project Manager to join our diverse and dynamic team. As a CMC Project Manager at ICON, you will be responsible for leading and managing regulatory affairs CMC projects, ensuring successful execution and delivery of project objectives.
This role is fully embedded with a hugely innovative Biotech where pioneering scientists and antibody engineers work side-by-side to accelerate the discovery of novel targets, disease pathways and differentiated therapeutic antibodies within Immunology.
Key Accountabilities and Responsibilities:
Responsible for achieving project goals, including timelines, budget, and scope.
Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between deliverables and define budget needs
Track, monitor and report key milestones and decision points to drive delivery of projects in accordance with corporate objectives., balancing scope, cost, timelines and risk;
Build strong working relationships with internal and external key stakeholders to ensure timely completion of CMC activities by continuously monitoring progress;
Perform critical path analysis and risks, taking into account cross-functional interdependencies in the overall development project plan;
Coordinate on the delivery of those critical path items through prioritization setting where required and mitigate or escalate the risk together with the project team;
Perform scenario simulations and advise on optimum development planning
Prepare and lead project team meetings including issuance of agenda, actions and meeting minutes to be documented, communicated and committed.
Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team
Qualifications:
Life Sciences degree
strong CMC project experience.
Experience in working with biologics
Excellent planning and organizational skills, able to multi-task in a multicultural environment and prioritize,
Strong analytical, problem solving and critical thinking skills with action-oriented follow through
Experience working with CMC Teams and managing relationships with CMC vendors is strongly preferred and capable of building effective relationships
MS Project, Power BI, or Planisware experience
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a requesthere.
Are you a current ICON Employee? Please click here to apply