- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director /Senior Director ... their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as...responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences ... areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or arbitrator on global projects.Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within the company ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analytical development activities and oncology project development.Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA submission ... immune disorders. SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing… more
- Merck & Co. (Durham, NC)
- Job DescriptionGENERAL SUMMARYThe Associate Director - Fermentation Technology Lead within our Bulk Facility Technical Operations organization will be responsible ... strategic decisions related to facility start-up and stabilization. The Associate Director will ensure optimized product quality and manufacturing processes, … more
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves ... Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction,...She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Tris Pharma (Monmouth Junction, NJ)
- …Collaborate with all Tris functions that contribute to the partnership, including R&D, Regulatory , CMC , Finance, Legal, and more. Understand their roles, their ... some combination across technical (eg, research, product development, clinical development, regulatory , CMC ) and business (eg, business development, alliance… more
- Merck & Co. (Rahway, NJ)
- …areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Insmed Incorporated (San Diego, CA)
- …Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as an Associate Director of MSAT where you will support pipeline programs that change lives. ... process of manufacturing AAV based therapies. Working closely with Process Development and CMC teams you will be the bridge between the laboratory and GMP… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Actalent (Boston, MA)
- Position: Director /Sr. Director of Regulatory CMC Location: Charlestown, MA About the Role We are seeking a creative and agile regulatory ... professional to join our collaborative team as the Director /Sr. Director of Regulatory CMC . This pivotal role involves providing leadership for our… more
- Merck (Rahway, NJ)
- **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director /Senior ... their assigned projects. **Position Description** The Principal Scientist / Director responsibilities include but are not limited to: +...but are not limited to: + Serve as a Regulatory CMC Project Lead and provide … more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is responsible for ... product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide...by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes...radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing… more
- Bristol Myers Squibb (Princeton, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for ... a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key...HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will serve as… more
