- Raytheon (Richardson, TX)
- …that create a safer, more secure world. At Raytheon's Optics Manufacturing Center ( CMC ), the Manufacturing Engineering team plays a critical role in sustaining our ... competitive edge in the design and production of complex optical components, assemblies, and systems. We are responsible for driving operational excellence-ensuring high-quality product delivery that meets schedule, cost, and safety targets.We collaborate… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Head of CMC Process Standards - Vaccines **Location** : Waltham, MA **About the Job** As **Head of CMC Process Standards** group within Global ... CMC Process Development and Industrialization ( CMC PD&I) function, you will manage a group of...(QbD) and Process Validation SMEs to establish phase appropriate CMC development and process validation standards and its deployment… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of regulatory ... this position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC … more
- AbbVie (North Chicago, IL)
- …Description The Associate Director, Regulatory Affairs Chemistry, Manufacturing and Controls ( CMC ) works with internal and external partners to deliver products to ... patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops...areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory… more
- Lilly (Indianapolis, IN)
- …better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients who ... Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC... CMC commercial solid oral products will use CMC technical knowledge and regulatory science expertise to drive… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC Regulatory Sciences ... play a critical role in overseeing the Chemistry, Manufacturing, and Controls ( CMC ) aspects of commercial submissions, ensuring compliance with US and ex-US… more
- Chiesi (Boston, MA)
- …Currently seeking for a Regulatory Affairs Specialist to support preparation of CMC related submissions and assessment of quality change controls for Chiesi's Global ... portfolio of commercial products. Main Responsibilities + Prepares and/or coordinate CMC activities for new product registrations, post approval changes, renewals,… more
- BeOne Medicines (San Mateo, CA)
- …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
- AbbVie (North Chicago, IL)
- …high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... key member of AST, has accountability for creating a CMC strategy and development plan that aligns with overarching...a differentiated product. Serves as the spokesperson for all CMC functions and ensures information flow among AST and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory ... portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… 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
- 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 ... over the world. We are seeking Regulatory Scientist GRA CMC -Parenteral Commercial Products to be a part of the...you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support… more
- Lilly (Indianapolis, IN)
- …better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients who ... Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical...Affairs - CMC Commercial Products will leverage CMC technical knowledge and regulatory science expertise to drive… more
- Gilead Sciences, Inc. (Foster City, CA)
- …create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for providing strategic ... direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible for guiding and overseeing the… more
- Lilly (Philadelphia, PA)
- …life better for people around the world. Responsibilities: The Associate / Manager, CMC Regulatory and IMP Manufacturing Operations is a hybrid role within CMC ... functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and...Manager is responsible for CMC regulatory operations, CMC change management, and document lifecycle management within IMP… more
- Lilly (Indianapolis, IN)
- …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 for Lilly's synthetic molecule portfolio. This… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Orchard Therapeutics (Boston, MA)
- …the Regulatory Team provide Regulatory and Chemistry, Manufacturing and Control ( CMC ) related expertise for development and commercial stage products, including ... priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance and development of Orchard's Cell & Gene… more
- Lilly (Philadelphia, PA)
- …communities through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the preparation and delivery of ... high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical...Responsible for the generation and execution of country specific CMC regulatory strategies + Author and review global … more
- Bristol Myers Squibb (Indianapolis, IN)
- …**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)...following. Other duties may be assigned. + Member of CMC Development Teams providing Quality (QA) input from pre-clinical… more
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