Defining global CMC regulatory strategy and decisions for development projects or marketed products ... Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent ...
Defining global CMC regulatory strategy and decisions for development projects or marketed products ... Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent ...
Senior Scientist, Product Development - Life Science & Biotech Reagents
Piscataway, NJ · On-site
$125K - $155K/yr
Medical
Dental
Vision
Life
Retirement
PTO
About GenScript Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation ... Experience and service in Early Discovery, Platform Development, or CMC within biopharma or top ...
Senior Scientist, Product Development - Life Science & Biotech Reagents
Piscataway, NJ · On-site
$125K - $155K/yr
Medical
Dental
Vision
Life
Retirement
PTO
About GenScript Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation ... Experience and service in Early Discovery, Platform Development, or CMC within biopharma or top ...
Director - CMC Regulatory Affairs (Gene Therapy)
Piscataway, NJ · Remote
$153K - $202K/yr
Remote (Anywhere in the U.S.) We're looking for an experienced Director - CMC Regulatory Affairs to join a well-funded, mid-sized Gene Therapy Biotech organization with a strong pipeline and proven ...
Quick apply
Director - CMC Regulatory Affairs (Gene Therapy)
Piscataway, NJ · Remote
$153K - $202K/yr
Remote (Anywhere in the U.S.) We're looking for an experienced Director - CMC Regulatory Affairs to join a well-funded, mid-sized Gene Therapy Biotech organization with a strong pipeline and proven ...
About GenScript Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation ... Experience and service in Early Discovery, Platform Development, or CMC within biopharma or top ...
Quick apply
About GenScript Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation ... Experience and service in Early Discovery, Platform Development, or CMC within biopharma or top ...
CMC Director, Regulatory Affairs
Morristown, NJ · Remote
$153K - $202K/yr
D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma ...
Quick apply
CMC Director, Regulatory Affairs
Morristown, NJ · Remote
$153K - $202K/yr
D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma ...
CMC Director, Regulatory Affairs
Morristown, NJ · On-site
$154K - $204K/yr
S/Ph.D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma ...
CMC Director, Regulatory Affairs
Morristown, NJ · On-site
$154K - $204K/yr
S/Ph.D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma ...
Director, CMC - Biologics & ADC
New York, NY · On-site
$210K - $250K/yr
D. in Biochemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field (or an M.S./B.S. with commensurate additional experience). * 8-10+ years of biopharmaceutical CMC experience ...
New
Director, CMC - Biologics & ADC
New York, NY · On-site
$210K - $250K/yr
D. in Biochemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field (or an M.S./B.S. with commensurate additional experience). * 8-10+ years of biopharmaceutical CMC experience ...
New
CMC Director, Regulatory Affairs
$154K - $204K/yr
S/Ph.D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma ...
CMC Director, Regulatory Affairs
$154K - $204K/yr
S/Ph.D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma ...
Director, CMC - Small Molecule Chemistry
New York, NY · On-site
$210K - $250K/yr
Experience in BOTH a small/emerging biotech and a large pharma environment, with the versatility to ... Strong command of ICH, FDA, and EMA CMC guidance and phase-appropriate GMP expectations, with ...
New
Director, CMC - Small Molecule Chemistry
New York, NY · On-site
$210K - $250K/yr
Experience in BOTH a small/emerging biotech and a large pharma environment, with the versatility to ... Strong command of ICH, FDA, and EMA CMC guidance and phase-appropriate GMP expectations, with ...
New
Principal Scientist, Regulatory CMC
Medical
Dental
Vision
Life
Retirement
PTO
IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that ... Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern ...
Principal Scientist, Regulatory CMC
Medical
Dental
Vision
Life
Retirement
PTO
IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that ... Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern ...
Principal Scientist, Regulatory CMC
Summit, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that ... Experience in the preparation of the submission of CMC modules in eCTD format required
Principal Scientist, Regulatory CMC
Summit, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that ... Experience in the preparation of the submission of CMC modules in eCTD format required
Senior Scientist, Regulatory CMC
Medical
Dental
Vision
Life
Retirement
PTO
IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that ... Position Summary The Senior Scientist, Regulatory CMC will assist in the development of global ...
Senior Scientist, Regulatory CMC
Medical
Dental
Vision
Life
Retirement
PTO
IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that ... Position Summary The Senior Scientist, Regulatory CMC will assist in the development of global ...
Associate Director, CMC Regulatory Affairs
Paramus, NJ · On-site
$170K - $190K/yr
Medical
Dental
Vision
Life
Retirement
PTO
Typically, 8 - 10 years of experience in the CMC field of the pharmaceutical/biotechnology industry, including a minimum of 5 years of CMC regulatory affairs. * A minimum of one NDA/BLA and multiple ...
Quick apply
Associate Director, CMC Regulatory Affairs
Paramus, NJ · On-site
$170K - $190K/yr
Medical
Dental
Vision
Life
Retirement
PTO
Typically, 8 - 10 years of experience in the CMC field of the pharmaceutical/biotechnology industry, including a minimum of 5 years of CMC regulatory affairs. * A minimum of one NDA/BLA and multiple ...
Senior Scientist, Regulatory CMC
Summit, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that ... Position Summary The Senior Scientist, Regulatory CMC will assist in the development of global ...
Senior Scientist, Regulatory CMC
Summit, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that ... Position Summary The Senior Scientist, Regulatory CMC will assist in the development of global ...
Global Viral Vector MSAT Lead
Raritan, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Minimum 10 years of in MSAT, tech transfer or process development. * Industrial biologics CMC ...
Global Viral Vector MSAT Lead
Raritan, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Minimum 10 years of in MSAT, tech transfer or process development. * Industrial biologics CMC ...
Associate Director, Regulatory Affairs - CMC
Medical
Dental
Vision
Retirement
Bachelor's degree in scientific discipline. A minimum of 7-8 years Regulatory Affairs experience and/or CMC technical writing experience in a pharmaceutical, biotechnology or related environment.
Associate Director, Regulatory Affairs - CMC
Medical
Dental
Vision
Retirement
Bachelor's degree in scientific discipline. A minimum of 7-8 years Regulatory Affairs experience and/or CMC technical writing experience in a pharmaceutical, biotechnology or related environment.
Associate Director, Regulatory Affairs - CMC
Warren, NJ · On-site
Medical
Dental
Vision
Retirement
Bachelor's degree in scientific discipline. A minimum of 7-8 years Regulatory Affairs experience and/or CMC technical writing experience in a pharmaceutical, biotechnology or related environment.
Associate Director, Regulatory Affairs - CMC
Warren, NJ · On-site
Medical
Dental
Vision
Retirement
Bachelor's degree in scientific discipline. A minimum of 7-8 years Regulatory Affairs experience and/or CMC technical writing experience in a pharmaceutical, biotechnology or related environment.
Principal Engineer, Lentivirus Downstream Process Development
Somerset, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical ... Legend Biotech Privacy Notice.
Principal Engineer, Lentivirus Downstream Process Development
Somerset, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical ... Legend Biotech Privacy Notice.
Associate Director, Global Regulatory Sciences - CMC
Madison, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
In this role, the GRS-CMC Associate Director will serve as the primary interface between Global ... biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC ...
Associate Director, Global Regulatory Sciences - CMC
Madison, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
In this role, the GRS-CMC Associate Director will serve as the primary interface between Global ... biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC ...
Associate Director, Global Regulatory Sciences - CMC
New Brunswick, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
In this role, the GRS-CMC Associate Director will serve as the primary interface between Global ... biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC ...
Associate Director, Global Regulatory Sciences - CMC
New Brunswick, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
In this role, the GRS-CMC Associate Director will serve as the primary interface between Global ... biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC ...
Cmc In Biotech information
What is a CMC in biotech position?
A CMC (Chemistry, Manufacturing, and Controls) position in biotech involves overseeing the development, manufacturing, and quality control of biopharmaceutical products. Professionals in this role ensure that products meet regulatory standards and are produced consistently, often requiring knowledge of GMP regulations, process development, and analytical techniques.
What is the difference between Cmc In Biotech vs Formulation Scientist?
| Aspect | Cmc In Biotech | Formulation Scientist |
|---|---|---|
| Required Credentials | Bachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledge | Bachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience |
| Work Environment | Laboratories, manufacturing facilities, regulatory settings | Laboratories, R&D departments, manufacturing units |
| Employer & Industry Usage | Biotech companies, pharmaceutical firms, contract manufacturing organizations | Pharmaceutical companies, biotech firms, contract labs |
While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.
What is a CMC in biotech?
In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing and producing a pharmaceutical product. CMC professionals ensure that manufacturing processes meet quality standards and regulatory requirements, often working with laboratory analysis, process validation, and compliance documentation.
What is the CMC department in biotech?
The CMC (Chemistry, Manufacturing, and Controls) department in biotech is responsible for developing, manufacturing, and ensuring the quality of biopharmaceutical products. It involves activities such as process development, validation, regulatory documentation, and quality control to ensure products meet safety and efficacy standards.
What are popular job titles related to Cmc In Biotech jobs in New York? For Cmc In Biotech jobs in New York, the most frequently searched job titles are:
What job categories do people searching Cmc In Biotech jobs in New York look for? The top searched job categories for Cmc In Biotech jobs in New York are:
- Director Preclinical
- Executive Director Of Regulatory Affairs
- Associate Director Regulatory Affairs Cmc
- Cmc Regulatory Affairs
- Associate Director Biopharma Pharmaceutical
- Director Peptide Synthesis
- Remote Legislative Affairs Director
- Vice President Of Regulatory Affairs
- Vice President Cmc Regulatory Affairs
- Director Stealth Biotech
What cities in New York are hiring for Cmc In Biotech jobs? Cities in New York with the most Cmc In Biotech job openings:
Contractor
Re-posted 6 days ago
Job description
Company Description
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Assist and support regulatory CMC managers in the following activities:
Defining global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.
Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project/product life cycle, to project teams and appropriate management levels within and outside of Reg CMC.
Influencing and negotiating within cross-functional teams to ensure quality submission planning and decision-making.
Single point of contact with other line functions
Review CMC regulatory documentation to ensure strategic direction and regulatory compliance are met.
Collecting documentation from other line functions to support submission preparation
Ensure databases are maintained to compliance
Qualifications
Skills:
Desirable: Experience in regulatory field, in particular regulatory CMC
Education:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
Additional Information
Best Regards,
Anuj Mehta
973-967-3402
About Artech
Sourced by ZipRecruiter
Artech is a leading IT staffing and consulting company based in Morristown, NJ, US. Since its foundation in 1992, Artech has mastered in complementing human expertise with technology and business acumen to produce world-class staffing solutions. The company caters to diverse industry sectors, including financial services, healthcare, telecommunication, energy and utilities, supply chain, and retail. It provides IT consulting, project management, professional and staff augmentation, and managed staffing services. Artech's mission is to provide exceptional IT staffing services to its clients by comprehending their business needs and then crafting a customized staffing strategy. Its notable achievement includes being recognized as one of the largest IT staffing companies in the U.S, according to Staffing Industry Analysts (SIA).
Industry
Recruiting and staffing services
Company size
10,000+ Employees
Headquarters location
Morristown, NJ, US
Year founded
1992