- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **About the role:** Join as a Digital CMC Scientist to support the planning, development and execution of the In ... R&D context. In this role, you will work closely with the Sustainable CMC and Innovation team as well as capability leads from all development functional… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Sr. Scientist , Regulatory Affairs CMC will implement regulatory Chemistry, Manufacturing, & Controls ( CMC ) ... Prepare and review of information required for development of Regulatory CMC dossiers for projects and products including clinical development, original… more
- Eurofins (Indianapolis, IN)
- …strategies and submissions in support of clinical trials. This position utilizes CMC technical knowledge to drive internal consistency and influence effective change ... not limited to: + Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions + Takes a proactive role in the… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. We are seeking Regulatory Scientist GRA CMC -Parenteral Commercial Products to be a part of the Lilly ... operational support for market registrations and post-approval submissions. The regulatory scientist will leverage CMC technical knowledge and regulatory science… more
- Lilly (Indianapolis, IN)
- …the next generation of life changing medicines to patients. **Job Description** The CMC AI/ML and Automation scientist will collaborate closely with scientists ... a collaborative, team-based approach to problem solving. Additionally, the AI/ML Scientist will contribute to the advancement of new capabilities by utilizing… more
- Cardinal Health (Columbus, OH)
- …Cardinal Health's Regulatory Science clients. Working remotely under the supervision of the CMC Supervisor, the Scientist I builds and formats Common Technical ... to Cardinal Health_** The _Scientist I, Chemistry, Manufacturing, and Control ( CMC )_ ensures efficient and quality production of product submission dossiers for… more
- AbbVie (Boston, MA)
- …approval of biologics drug substances by authoring Chemistry, Manufacturing, and Controls ( CMC ) filing content and by leading cross-functional CMC teams ... ensure technical information is accurately transcribed into regulatory documents. + Lead CMC teams in the development of robust control strategies and presentation… more
- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. We are seeking Regulatory Scientist GRA- CMC to be a part of the Lilly global regulatory group to ... support for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC ...regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC technical knowledge… more
- AbbVie (South San Francisco, CA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long ... South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of...to human clinical studies and eventual licensure. This Senior Scientist I role is within a team of highly… more
- Merck (North Wales, PA)
- **Job Description** This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director, the Associate ... Principal Scientist is responsible for implementing regulatory strategies for our...combination product research, development and/or manufacturing + Experience with CMC regulatory where drug is the primary mode of… more
- Organon & Co. (Jersey City, NJ)
- …for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes oversight of ... development due diligence activities. **Responsibilities** + Provide global strategic regulatory CMC overview for respective products and portfolio. + Serve as the… more
- Atlantic Health System (Pompton Plains, NJ)
- …+ High school diploma or equivalent required + Documented training as defined in the CLIA regulation 42CFR493.1489(b) + Non-degree semester hours in medical ... Responsible for a variety of routine and complex technical tasks in the performance of laboratory tests to obtain data for use in the diagnosis and treatment of disease. Principal Accountabilities: + Comfortable with emergency situations such as Massive… more
- Atlantic Health System (Pompton Plains, NJ)
- …+ High school diploma or equivalent required + Documented training as defined in the CLIA regulation 42CFR493.1489(b) + Non-degree semester hours in medical ... + Perform testing in the laboratory and report results according to SOP + Operate, maintain, and troubleshoot laboratory analyzers and equipment + Perform quality control tasks and maintain laboratory documentation according to SOP + Maintain and manage… more
- Sanofi Group (Framingham, MA)
- ** Scientist - VIE Contract** + _Location: United States of America, Framingham_ + _Target start date: 01/07/2025_ iMove, the Sanofi VIE Program, is available to ... impact on the lives of countless people worldwide. As_ **_Scientist VIE_** _in our CMC Development team you will collaborate with other scientists in the team and… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage ... medicines that make life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new… more
- Bristol Myers Squibb (Indianapolis, IN)
- …global leader in radiopharmaceuticals. **Position Summary** The Manager (Sr. Scientist ), Radiopharmaceuticals will be responsible for advancing scientific and ... Responsibilities include driving technology transfer, Chemistry Manufacturing and Control ( CMC ), development and commercialization programs for drug products and… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Principal Scientist , LCM Technical Lead **Location:** Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every ... to patients and their families. As the DS Process LCM- CMC leader, you will be responsible for managing second-generation...your programs. You may also represent DS function in CMC teams of new products to enable pace of… more
- J&J Family of Companies (Malvern, PA)
- …**We are searching for the best talent for a Distinguished Scientist , Large Molecule Biologics to be in Malvern, PA or Spring ... House, PA.** **Purpose:** Within the CMC group, you will lead multiple CMC Teams spanning from pre-NME through post-Approval, including Life Cycle Management… more
- J&J Family of Companies (Malvern, PA)
- …**We are searching for the best talent for a Distinguished Scientist , Protein Conjugates to be located in** **Malvern, PA or Spring ... House, PA,** **Purpose:** Within the CMC group, you will lead multiple CMC Teams spanning from pre-NME through post-Approval, including Life Cycle Management… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead Sciences is seeking a talented and highly motivated Senior Scientist to join our Pre-Pivotal Biologics Analytical Operations group. Our collaborative ... into the clinic. The successful candidate is expected to serve as the CMC analytical lead on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he… more
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