- Gilead Sciences, Inc. (Washington, DC)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Director , CMC Regulatory Affairs Policy, Advisory and Intelligence is part ... stakeholders in developing and advocating policy positions (internally and externally) in the CMC regulatory sphere. The role will be focused on the North American… more
- J&J Family of Companies (Malvern, PA)
- …more at https://www.jnj.com/innovative-medicine **We are searching for the best talent for a Director , CMC Portfolio Management to be in Malvern, PA or Raritan, ... NJ.** **Purpose:** The Director , CMC Portfolio Management will share oversight of the scientific projects within TDS as they relate to the internal portfolio.… more
- UTMB Health (Gatesville, TX)
- Regional Medical Director , CMC **Gatesville, Texas, United States** Physician UTMB Health Requisition # 2500313 The mission of Correctional Managed Care is to ... Texas Juvenile Justice Department (TJJD). **_JOB SUMMARY_** **:** Serves as medical director for a number of correctional facilities within a designated region.… more
- Astellas Pharma (Northbrook, IL)
- ** Director CMC Development PRTL Packaging & Device US** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? ... require work in the office. **Purpose and Scope:** The Director provides strategic leadership, policies, and advanced technical expertise...policies for the Americas. As a member of global CMC teams, this person will lead all aspects of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** We are seeking an Associate Director , Regulatory Affairs CMC candidate to sit at our Foster City, ... CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction, operational support,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Digital Product Owner ( Director ) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About the Job** At Sanofi, we're ... new medicine to patients faster and more efficiently. As a Director -Level Product Owner for in silico CMC , you will join a dynamic team committed to driving… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within ... project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main… more
- WuXi AppTec (Cranbury, NJ)
- …drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof. **Please ... of relevant pharmaceutical or biotech industry experience in discovery chemistry, CMC process development and/or GMP manufacturing. + Working knowledge and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance ... develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in… more
- Merck (North Wales, PA)
- …Description** This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director , the Associate ... pharmaceutical or combination product research, development and/or manufacturing + Experience with CMC regulatory where drug is the primary mode of action (IND, CTA,… more
- BeiGene (Harrisburg, PA)
- …an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team based ... China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory submissions and health… more
- Boehringer Ingelheim (Ridgefield, CT)
- …that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for the coordination ... and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary internal contact for all US… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and ... manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
- Takeda Pharmaceuticals (Lexington, MA)
- …This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical ... follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA … more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in various ... world-wide + Demonstrates leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert… more
- Lilly (Indianapolis, IN)
- …the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control ( CMC ) scientists to join us in developing and bringing life-changing new medicines ... all over the world. We are seeking Regulatory Scientist GRA- CMC to be a part of the Lilly global...you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support… more
- AbbVie (Boston, MA)
- …cutting-edge control strategies and influencing the generation of data packages that support the CMC control strategy. The Director II oversees a team of authors ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director II NBE Author leads the development and oversight of Chemistry,… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** We are seeking a highly skilled and experienced Director to join our External Alternative CMC Development (EACD) team. The ideal candidate will ... external collaborations with Contract Development and Manufacturing Organizations (CDMOs). The Director will support all drug product-related CMC activities… more
- AbbVie (North Chicago, IL)
- …(CPD-DD) to enable the early-stage pipeline. This will be in collaboration with our CMC team, CMC Product Development Director , and Delivery System Senior ... and labeling. You will manage product development timelines and scopes to support CMC gate reviews and clinical phase plans. Collaboration with clinical teams is… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Digital Product Owner (Associate Director /Senior Manager) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About the ... to patients faster and more efficiently. As an Associate Director /Senior Manager Product Owner for in silico CMC... Director /Senior Manager Product Owner for in silico CMC , you will join a dynamic team committed to… more
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