Reviews CMC sections of regulatory submissions, as well as the interactions and responses with ... Experience supporting Small Molecule programs required Contract length: 12 months with the chance ...
Reviews CMC sections of regulatory submissions, as well as the interactions and responses with ... Experience supporting Small Molecule programs required Contract length: 12 months with the chance ...
Head of CMC
Redwood City, CA · On-site
$277K - $416K/yr
There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...
Quick apply
Head of CMC
Redwood City, CA · On-site
$277K - $416K/yr
There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...
Director, CMC - Formulations
San Diego, CA · Remote
$190K - $260K/yr
Manage relationships with various contract development and manufacturing organizations (CDMOs ... Research CMC and formulation topics to support Tang Capital's investments * Participate in business ...
Quick apply
Director, CMC - Formulations
San Diego, CA · Remote
$190K - $260K/yr
Manage relationships with various contract development and manufacturing organizations (CDMOs ... Research CMC and formulation topics to support Tang Capital's investments * Participate in business ...
Head of CMC
Redwood City, CA · On-site
$277K - $416K/yr
There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...
Head of CMC
Redwood City, CA · On-site
$277K - $416K/yr
There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...
Director, Regulatory Affairs, CMC
$153K - $202K/yr
... contract manufacturing organizations, expert consultants, and global health authorities ... Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory ...
Director, Regulatory Affairs, CMC
$153K - $202K/yr
... contract manufacturing organizations, expert consultants, and global health authorities ... Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory ...
Head of CMC
Redwood City, CA · On-site
$300 - $380/hr
There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...
Head of CMC
Redwood City, CA · On-site
$300 - $380/hr
There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...
Director, Regulatory Affairs, CMC
Charleston, WV · Remote
$153K - $202K/yr
... contract manufacturing organizations, expert consultants, and global health authorities ... Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory ...
Quick apply
Director, Regulatory Affairs, CMC
Charleston, WV · Remote
$153K - $202K/yr
... contract manufacturing organizations, expert consultants, and global health authorities ... Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory ...
Director Regulatory Affairs - CMC
$160K - $211K/yr
Acts as regulatory CMC liaison with partner companies and contract manufacturers * Provides expertise in translating regulatory requirements into practical, workable plans * Interacts with regulatory ...
Quick apply
Director Regulatory Affairs - CMC
$160K - $211K/yr
Acts as regulatory CMC liaison with partner companies and contract manufacturers * Provides expertise in translating regulatory requirements into practical, workable plans * Interacts with regulatory ...
Director, CMC - Formulations
San Diego, CA · On-site
$190K - $260K/yr
Manage relationships with various contract development and manufacturing organizations (CDMOs ... Research CMC and formulation topics to support Tang Capital's investments * Participate in business ...
Director, CMC - Formulations
San Diego, CA · On-site
$190K - $260K/yr
Manage relationships with various contract development and manufacturing organizations (CDMOs ... Research CMC and formulation topics to support Tang Capital's investments * Participate in business ...
Foster City, CA Contract Duration: 6-18 months Rate: Negotiable Responsibilities: * Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area ...
Quick apply
Foster City, CA Contract Duration: 6-18 months Rate: Negotiable Responsibilities: * Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area ...
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$245K - $285K/yr
... contract organizations and consultants. Ensure that all applicable regulatory requirements/options ... Provide guidance and advice on regulatory CMC environments and trends; provide assessment of the ...
Quick apply
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$245K - $285K/yr
... contract organizations and consultants. Ensure that all applicable regulatory requirements/options ... Provide guidance and advice on regulatory CMC environments and trends; provide assessment of the ...
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$245K - $285K/yr
... contract organizations and consultants. Ensure that all applicable regulatory requirements/options ... Provide guidance and advice on regulatory CMC environments and trends; provide assessment of the ...
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$245K - $285K/yr
... contract organizations and consultants. Ensure that all applicable regulatory requirements/options ... Provide guidance and advice on regulatory CMC environments and trends; provide assessment of the ...
CMC Regulatory Affairs Consultant Job Type ... Contract - 12 Months Location: Wilmington, DE - Hybrid/Onsite Work Arrangement: 3 Days Onsite per ...
CMC Regulatory Affairs Consultant Job Type ... Contract - 12 Months Location: Wilmington, DE - Hybrid/Onsite Work Arrangement: 3 Days Onsite per ...
Senior Director, Regulatory CMC
$245K - $285K/yr
... contract organizations and consultants. Ensure that all applicable regulatory requirements/options ... Provide guidance and advice on regulatory CMC environments and trends; provide assessment of the ...
Senior Director, Regulatory CMC
$245K - $285K/yr
... contract organizations and consultants. Ensure that all applicable regulatory requirements/options ... Provide guidance and advice on regulatory CMC environments and trends; provide assessment of the ...
Lead CDMO/CMO CMC vendor selection process in collaboration with Procurement, Quality and CMC SMEs, and serve as the relationship lead to our internal and external contract manufacturing partners
New
Lead CDMO/CMO CMC vendor selection process in collaboration with Procurement, Quality and CMC SMEs, and serve as the relationship lead to our internal and external contract manufacturing partners
New
Work with manufacturing sites and contract sites to ensure the on-time compilation of high quality CTD Module III documents * Evaluate and manage the Technical CMC dossier documentation involved in ...
Work with manufacturing sites and contract sites to ensure the on-time compilation of high quality CTD Module III documents * Evaluate and manage the Technical CMC dossier documentation involved in ...
This position is posted ONLY for our current QUEST DIAGNOSTIC Contract Employees ... Only CURRENT Quest employees affiliated with CMC need apply for this position.
This position is posted ONLY for our current QUEST DIAGNOSTIC Contract Employees ... Only CURRENT Quest employees affiliated with CMC need apply for this position.
CMC Program Lead, Commercial Radiochemistry
OR · On-site +1
Lead CDMO/CMO CMC vendor selection process in collaboration with Procurement, Quality and CMC SMEs, and serve as the relationship lead to our internal and external contract manufacturing partners
New
CMC Program Lead, Commercial Radiochemistry
OR · On-site +1
Lead CDMO/CMO CMC vendor selection process in collaboration with Procurement, Quality and CMC SMEs, and serve as the relationship lead to our internal and external contract manufacturing partners
New
Sr. Project Manager
Dallas, TX · On-site
Coach and develop Project Managers and Assistant PMs to build CMC's next generation of project leaders Contract, Budget & Change Management * Ensure full contracts compliance and rigorous financial ...
Quick apply
Sr. Project Manager
Dallas, TX · On-site
Coach and develop Project Managers and Assistant PMs to build CMC's next generation of project leaders Contract, Budget & Change Management * Ensure full contracts compliance and rigorous financial ...
Director/ Senior Director, Regulatory CMC
Boston, MA · On-site
$250K - $265K/yr
Maintain responsibility for all CMC Regulatory timelines, that also includes managing contract staff and vendors relevant to CMC activities. Build and maintain strong relationships with internal and ...
Director/ Senior Director, Regulatory CMC
Boston, MA · On-site
$250K - $265K/yr
Maintain responsibility for all CMC Regulatory timelines, that also includes managing contract staff and vendors relevant to CMC activities. Build and maintain strong relationships with internal and ...
Cmc Contract information
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$17
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$49
How much do cmc contract jobs pay per hour?
What is the difference between Cmc Contract vs Cmc Coordinator?
| Aspect | Cmc Contract | Cmc Coordinator |
|---|---|---|
| Required Credentials | Typically requires a degree in life sciences or related field, with experience in contract management | Usually requires a degree in life sciences, with some experience in project coordination or administration |
| Work Environment | Works primarily in legal, regulatory, or contract management departments within biotech or pharma companies | Works in project teams, supporting CMC activities in pharmaceutical or biotech settings |
| Employer & Industry Usage | Commonly employed in pharmaceutical, biotech, and contract research organizations | Found in similar industries, often supporting CMC teams in drug development |
The main difference is that a Cmc Contract focuses on managing and negotiating contracts related to CMC activities, while a Cmc Coordinator handles the coordination and administrative support within CMC projects. Both roles require familiarity with CMC processes, but their responsibilities and focus areas differ.
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$70/hr
Full-time
Re-posted yesterday
Vertex Pharmaceuticals rating
6.5
Based on 5 frontline employees who took The Breakroom Quiz
78th of 86 rated pharmaceutical
Job description
The Chemistry Manufacturing Controls Manager will be responsible for the detailed planning, preparation and operational execution of a multi-product program in the international region.
This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams.
Key Duties and Responsibilities
- Execute Lifecycle Management (LCM) strategy and submissions of marketed products with a focus in the international regions.
- Planning and execution of international regulatory CMC submissions, including creation of content plans and ensuring cross functional alignment
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
- Participates effectively in cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
- Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Required Knowledge/Skills
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, ICH, international agencies) guidelines
- Strong problem-solving skills and the ability to present the overall assessment for management alignment
- Ability to collaborate and communicate in an open, clear, complete and timely manner
- Strong sense of planning and prioritization, with demonstrated results
Required Education Level & Experience
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Typically requires 5 years of experience in the pharmaceutical industry or related field
- Experience supporting Small Molecule programs required
Contract length: 12 months with the chance to extend.
Pay Range
$70/hr. - $80/hr.
Shift/Hours
Monday-Friday; Remote: EST hours
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals ("Vertex"). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex's Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
(collectively, "Atrium Alerts"). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com.
If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
What Vertex Pharmaceuticals employees say
Hours and flexibility
Workplace
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About Vertex Pharmaceuticals
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1,001 - 5,000 Employees
Headquarters location
Boston, MA, US
Year founded
1989