A minimum of 8 years Regulatory CMC experience and/or CMC technical writing experience in a pharmaceutical or biotechnology environment including injectables. Required Skills and Competencies:
A minimum of 8 years Regulatory CMC experience and/or CMC technical writing experience in a pharmaceutical or biotechnology environment including injectables. Required Skills and Competencies:
Associate Director, Regulatory Affairs - CMC
Plano, TX · On-site
$180 - $240/hr
A minimum of 8 years Regulatory CMC experience and/or CMC technical writing experience in a pharmaceutical or biotechnology environment including injectables. Required Skills and Competencies:
New
Associate Director, Regulatory Affairs - CMC
Plano, TX · On-site
$180 - $240/hr
A minimum of 8 years Regulatory CMC experience and/or CMC technical writing experience in a pharmaceutical or biotechnology environment including injectables. Required Skills and Competencies:
New
Experience in biotech/pharma technical/CMC development and clinical product manufacturing (GMP) and/or clinical/preclinical development (GCP/GLP); for devices or combination products, experience of ...
Experience in biotech/pharma technical/CMC development and clinical product manufacturing (GMP) and/or clinical/preclinical development (GCP/GLP); for devices or combination products, experience of ...
Experience in biotech/pharma technical/CMC development and clinical product manufacturing (GMP) and/or clinical/preclinical development (GCP/GLP); for devices or combination products, experience of ...
Experience in biotech/pharma technical/CMC development and clinical product manufacturing (GMP) and/or clinical/preclinical development (GCP/GLP); for devices or combination products, experience of ...
$85K - $95K/yr
... optimization, CMC development, preclinical and clinical studies, commercial production, and ... Experienced in Biotech Sales, Life Sciences Sales, Cell and Gene Therapy Sales, Drug Development ...
$85K - $95K/yr
... optimization, CMC development, preclinical and clinical studies, commercial production, and ... Experienced in Biotech Sales, Life Sciences Sales, Cell and Gene Therapy Sales, Drug Development ...
... biotech, pharmaceutical, and medical device companies. The right candidate must have expertise in ... Build relationships with R&D, CMC, Quality, and Regulatory leaders within target organizations.
... biotech, pharmaceutical, and medical device companies. The right candidate must have expertise in ... Build relationships with R&D, CMC, Quality, and Regulatory leaders within target organizations.
... biotech, pharmaceutical, and medical device companies. The right candidate must have expertise in ... Build relationships with R&D, CMC, Quality, and Regulatory leaders within target organizations.
Quick apply
... biotech, pharmaceutical, and medical device companies. The right candidate must have expertise in ... Build relationships with R&D, CMC, Quality, and Regulatory leaders within target organizations.
... biotech, pharmaceutical, and medical device companies. The right candidate must have expertise in ... Build relationships with R&D, CMC, Quality, and Regulatory leaders within target organizations.
... biotech, pharmaceutical, and medical device companies. The right candidate must have expertise in ... Build relationships with R&D, CMC, Quality, and Regulatory leaders within target organizations.
Process Development Scientist
Plano, TX · On-site
... in radiopharmaceutical development to join our CMC team. The successful candidate will design ... Experience working in a pharmaceutical/biotech setting * Excellent written and verbal communication ...
Process Development Scientist
Plano, TX · On-site
... in radiopharmaceutical development to join our CMC team. The successful candidate will design ... Experience working in a pharmaceutical/biotech setting * Excellent written and verbal communication ...
VP, Program Management
Austin, TX · On-site
... CMC, nonclinical, and beyond - ensuring that nothing falls through the cracks, that leadership ... Requirements: * ~10+ years in biotech/pharma drug development, with meaningful time in a program or ...
VP, Program Management
Austin, TX · On-site
... CMC, nonclinical, and beyond - ensuring that nothing falls through the cracks, that leadership ... Requirements: * ~10+ years in biotech/pharma drug development, with meaningful time in a program or ...
... CMC, nonclinical, and beyond - ensuring that nothing falls through the cracks, that leadership ... Requirements: * ~10+ years in biotech/pharma drug development, with meaningful time in a program or ...
... CMC, nonclinical, and beyond - ensuring that nothing falls through the cracks, that leadership ... Requirements: * ~10+ years in biotech/pharma drug development, with meaningful time in a program or ...
Scout the global biotech landscape to identify companies with CGT assets in pre-clinical through ... Act as a bridge between the client's CMC (Chemistry, Manufacturing, and Controls) needs and our ...
Scout the global biotech landscape to identify companies with CGT assets in pre-clinical through ... Act as a bridge between the client's CMC (Chemistry, Manufacturing, and Controls) needs and our ...
... including CMC technical documents, supplemental information, and method validation strategy ... pharmaceutical or biotechnology industry, with a minimum of three years in a site quality ...
... including CMC technical documents, supplemental information, and method validation strategy ... pharmaceutical or biotechnology industry, with a minimum of three years in a site quality ...
... within a Biotechnology or Pharmaceutical company, or in a consulting role serving those ... CMC, CMO management, demand planning, costing, manufacturing operations * Commercial Operations:
... within a Biotechnology or Pharmaceutical company, or in a consulting role serving those ... CMC, CMO management, demand planning, costing, manufacturing operations * Commercial Operations:
... within a Biotechnology or Pharmaceutical company, or in a consulting role serving those ... CMC, CMO management, demand planning, costing, manufacturing operations * Commercial Operations:
... within a Biotechnology or Pharmaceutical company, or in a consulting role serving those ... CMC, CMO management, demand planning, costing, manufacturing operations * Commercial Operations:
... within a Biotechnology or Pharmaceutical company, or in a consulting role serving those ... CMC, CMO management, demand planning, costing, manufacturing operations * Commercial Operations:
... within a Biotechnology or Pharmaceutical company, or in a consulting role serving those ... CMC, CMO management, demand planning, costing, manufacturing operations * Commercial Operations:
... Biotechnology, Biomanufacturing or another related field. * 7+ years of cell therapy manufacturing ... As a Principal Manufacturing Associate , you will play a key role in supporting our CMC-GMP ...
... Biotechnology, Biomanufacturing or another related field. * 7+ years of cell therapy manufacturing ... As a Principal Manufacturing Associate , you will play a key role in supporting our CMC-GMP ...
Role Overview We are seeking a Senior Manufacturing Associate to support our CMC-GMP Manufacturing ... Associate's or Bachelor'sdegree in a scientific field (e.g., biology, biotechnology, or related ...
Role Overview We are seeking a Senior Manufacturing Associate to support our CMC-GMP Manufacturing ... Associate's or Bachelor'sdegree in a scientific field (e.g., biology, biotechnology, or related ...
Azure Data Solutions Architect
Dallas, TX · On-site
$62.75 - $81.75/hr
... in the biotech/pharmaceutical/ healthcare/diagnostics/health insurance space. * Extensive ... Subject matter expertise in Pharma CMC and scientific domains. * Experience in applying data ...
Quick apply
Azure Data Solutions Architect
Dallas, TX · On-site
$62.75 - $81.75/hr
... in the biotech/pharmaceutical/ healthcare/diagnostics/health insurance space. * Extensive ... Subject matter expertise in Pharma CMC and scientific domains. * Experience in applying data ...
Role Overview We are seeking a Senior Manufacturing Associate to support our CMC-GMP Manufacturing ... Associate's or Bachelor's degree in a scientific field (e.g., biology, biotechnology, or related ...
Role Overview We are seeking a Senior Manufacturing Associate to support our CMC-GMP Manufacturing ... Associate's or Bachelor's degree in a scientific field (e.g., biology, biotechnology, or related ...
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.
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What job categories do people searching Cmc In Biotech jobs in Texas look for? The top searched job categories for Cmc In Biotech jobs in Texas are:
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Full-time
Posted 8 days ago
Job description
Description
Orano Med Theranostics
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
The Associate Director, Regulatory Affairs - CMC will be responsible for leading the global regulatory CMC strategy for product development and registration, and for the preparation of CMC dossier in the expanding field of radiopharmaceuticals in the US and in EU.
This global role will join the regulatory team and will report directly to the Head of Regulatory Affairs. The person will work cross-functionally with the CMC team and the manufacturing sites to lead the regulatory CMC strategy and the preparation of regulatory CMC documentation and submissions in adherence to relevant regulatory requirements and company standards.
Key Responsibilities:
Requirements
All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.
Minimum Qualifications:
Required Skills and Competencies:
Orano Med Theranostics
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
The Associate Director, Regulatory Affairs - CMC will be responsible for leading the global regulatory CMC strategy for product development and registration, and for the preparation of CMC dossier in the expanding field of radiopharmaceuticals in the US and in EU.
This global role will join the regulatory team and will report directly to the Head of Regulatory Affairs. The person will work cross-functionally with the CMC team and the manufacturing sites to lead the regulatory CMC strategy and the preparation of regulatory CMC documentation and submissions in adherence to relevant regulatory requirements and company standards.
Key Responsibilities:
- Leads the development and preparation of global (US and EU) CMC-related submission documents for the pipeline of radiopharmaceutical products. This includes authoring, review and consolidation to deliver high-quality documents. Working in close collaboration with the CMC team (Manufacturing, Quality, R&D process), the regulatory CMC lead will collect technical data from relevant partners to write regulatory CMC documents and support the overall project goals.
- Develops robust global regulatory CMC strategies for the pipeline of radiopharmaceutical products. Identifies risks and proposes risk mitigation to enable successful regulatory submissions and approvals. Aligns within Regulatory Affairs to enable one regulatory voice.
- The regulatory submissions include but are not limited to the M3/CMC section of INDs/CTAs (IMPD-Q), DMF/ASMF, briefing documents, response to queries, Orphan Drug Applications, and annual reports.
- Manages regulatory CMC agency interactions and meetings.
- Meets current regulatory standards and achieves timely submissions, to enable approval on the first review cycle. Effectively interprets and applies regulatory CMC guidance. Provides recommendations and solutions to cross-functional teams and key stakeholders.
- Works with the Regulatory Operations vendor to coordinate publishing and submission for CMC dossiers (eCTD)
- Leads or contributes to the development of internal processes to improve the regulatory and CMC ways of working.
- Remains current on CMC regulatory intelligence.
Requirements
All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.
Minimum Qualifications:
- Bachelor's degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) is a plus.
- A minimum of 8 years Regulatory CMC experience and/or CMC technical writing experience in a pharmaceutical or biotechnology environment including injectables.
Required Skills and Competencies:
- Demonstrated hands-on experience in pharmaceutical development, registration in the US and/or EU, and interaction with health authorities. Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, DMF/ASMF, briefing documents, and response to agency questions.
- Technical knowledge in small molecules with experience in translating to a regulatory document. Knowledge of radiopharmaceuticals and innovative platforms is a plus.
- Knowledge of relevant global CMC regulations and guidelines (ICH, US, EU)
- Experience within a GMP environment with a firm understanding of industry regulations and best practices
- Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Excellent verbal and written communication skills. Able to defend the regulatory CMC position while maintaining positive professional relationships
- Proactive, able to work independently and collaboratively in a fast-paced emerging field
- Analytical thinker with good problem-solving skills and the capacity to adapt to a field with relatively few guidelines available.
- Excellent planning and organization skills including the ability to support multiple projects.
- Proficiency with Microsoft Office.
- Travel requirements: Up to 10% travel