... CMC experience, preferably in the biologics or cell and gene therapy field Contract length: 6 months with the chance to extend. Pay Range $70/hr. - $80/hr. Shift/Hours Monday-Friday; Remote: EST ...
... CMC experience, preferably in the biologics or cell and gene therapy field Contract length: 6 months with the chance to extend. Pay Range $70/hr. - $80/hr. Shift/Hours Monday-Friday; Remote: EST ...
CMC Writer
Paramus, NJ · On-site
Contract * Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables for CMC workstreams, ensuring alignment with ...
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CMC Writer
Paramus, NJ · On-site
Contract * Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables for CMC workstreams, ensuring alignment with ...
CMC Writer
Paramus, NJ · On-site
Contract * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and ...
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CMC Writer
Paramus, NJ · On-site
Contract * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and ...
Position Overview Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be ...
Position Overview Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be ...
CMC Leader (Director)
Upper Providence, PA · On-site
Ensuring plans are captured in the further medicine CMC/SC master strategy & ToA contract (including all of the lifecycle P3 and CMC/SC sub-projects and responsibilities). Secure timely decisions on ...
CMC Leader (Director)
Upper Providence, PA · On-site
Ensuring plans are captured in the further medicine CMC/SC master strategy & ToA contract (including all of the lifecycle P3 and CMC/SC sub-projects and responsibilities). Secure timely decisions on ...
Program Director - Transportation
Orlando, FL · On-site
Manage our CMC Contract to include internal financial reporting and performance * Manage our sub-consultant contracts, including staffing and services performed * Prepare dashboard reports including ...
Program Director - Transportation
Orlando, FL · On-site
Manage our CMC Contract to include internal financial reporting and performance * Manage our sub-consultant contracts, including staffing and services performed * Prepare dashboard reports including ...
Program Director - Transportation
Orlando, FL · On-site
Hill International is seeking a Program Director - Transportation in Orlando, Florida Program Director for the Central Florida Expressway Authority Construction Management Consultant Contract (CMC)
Program Director - Transportation
Orlando, FL · On-site
Hill International is seeking a Program Director - Transportation in Orlando, Florida Program Director for the Central Florida Expressway Authority Construction Management Consultant Contract (CMC)
CMC Writer
Paramus, NJ · On-site
$45 - $50/hr
Contract Duration: 6 Months Work Type: Hybrid * A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents ...
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CMC Writer
Paramus, NJ · On-site
$45 - $50/hr
Contract Duration: 6 Months Work Type: Hybrid * A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents ...
Contract: Manager, CMC Stability Management and Analysis
Bothell, WA · On-site
$88.10 - $100.05/hr
Position Overview Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be ...
Contract: Manager, CMC Stability Management and Analysis
Bothell, WA · On-site
$88.10 - $100.05/hr
Position Overview Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be ...
Ensure these are captured in the medicine CMC/SC master strategy & plan and develop the ToA contract with the MSCL. Secure timely decisions on milestone progression through governance (CMC board, DRB ...
Ensure these are captured in the medicine CMC/SC master strategy & plan and develop the ToA contract with the MSCL. Secure timely decisions on milestone progression through governance (CMC board, DRB ...
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
Quick apply
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
Manage relationships with various contract development and manufacturing organizations (CDMOs ... Research CMC and formulation topics to support Tang Capitals investments * Participate in business ...
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Manage relationships with various contract development and manufacturing organizations (CDMOs ... Research CMC and formulation topics to support Tang Capitals investments * Participate in business ...
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence ... Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
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 ...
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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 ...
Global Regulatory CMC Manager
Madison, NJ · On-site
Contract Position Summary The Global Regulatory CMC Senior Consultant is responsible for supporting the development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory ...
Global Regulatory CMC Manager
Madison, NJ · On-site
Contract Position Summary The Global Regulatory CMC Senior Consultant is responsible for supporting the development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory ...
Director, CMC Program Management - Drug Substance
Boston, MA · On-site
$180K - $220K/yr
Monitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnel. * Support CMC activities including tracking relevant GMP and Regulatory ...
Director, CMC Program Management - Drug Substance
Boston, MA · On-site
$180K - $220K/yr
Monitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnel. * Support CMC activities including tracking relevant GMP and 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 Program Management - Drug Substance
Boston, MA · On-site
$180K - $220K/yr
Monitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnel. * Support CMC activities including tracking relevant GMP and Regulatory ...
Director, CMC Program Management - Drug Substance
Boston, MA · On-site
$180K - $220K/yr
Monitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnel. * Support CMC activities including tracking relevant GMP and Regulatory ...
... contract manufacturers. * Manage interactions with FDA and other global regulatory authorities for ... Author and lead CMC content for Health Authority meeting briefing packages, including development ...
... contract manufacturers. * Manage interactions with FDA and other global regulatory authorities for ... Author and lead CMC content for Health Authority meeting briefing packages, including development ...
Cmc Contract information
See salary details
$17.07 - $20
19% of jobs
$20.52 is the 25th percentile. Wages below this are outliers.
$20 - $22.92
33% of jobs
$22.92 - $25.85
19% of jobs
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$25.85 - $28.78
12% of jobs
$28.78 - $31.71
7% of jobs
$31.71 - $34.64
4% of jobs
$34.64 - $37.57
1% of jobs
$37.57 - $40.49
1% of jobs
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1% of jobs
$43.42 - $46.35
1% of jobs
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$17
$26
$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.

$70/hr
Full-time
Posted 17 days ago
Job description
The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy regulatory CMC strategies for marketed products. This role contributes to the planning, preparation and submission of regulatory CMC documentation. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable international regulatory requirements are considered and appropriately incorporated into the lifecycle of cell and gene therapy programs.
Key Duties & Responsibilities
- 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
- Contributes to the development of global regulatory CMC strategies for commercial products
- Works with regulatory and technical colleagues to ensure timely submission and approval of CMC changes in the post approval environment
- Provides regulatory CMC guidance to cross-functional teams and key stakeholders
- Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Required Education Level & Experience
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in FDA, EMA and international regulatory guidelines
- Experience in the preparation, reviews and submissions of CMC post approval variations
- Strong sense of planning, strategic thinking and problem-solving skills
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
- Capable of strategic thinking with ability to resolve complex and ambiguous situations
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- 5 years of Regulatory CMC experience, preferably in the biologics or cell and gene therapy field
Contract length: 6 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
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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