- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of...areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Description Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies ... and a robust pipeline of promising new medicines to help people. Under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Description Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies ... of promising new medicines to help people. Under the Group 's 2025 Vision to become a "Global Pharma Innovator...incl. coordinating Reg Intelligence & Policy activities with the Regulatory- CMC function and corporate affairs as needed. In the… more
- Novo Nordisk Inc. (Boulder, CO)
- …and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions The successful ... The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its...Senior Scientist to join our RNAi Chemical Development group in Boulder, Colorado. You will lead and drive… more
- Merck & Co. (Rahway, NJ)
- …a local FLEx strategy, securing support for that strategy with partners and R&D Senior Leadership, and executing on plans to deliver the strategy.- This is inclusive ... experience developing staffFluency in the clinical quality management system and CMC process, across modalities and inclusive of facility/technology development and… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… 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 ... to be a part of the Lilly post-approval regulatory group to support global submissions and registrations. As the...you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... Legacy of Innovation 110 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of...areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- **Join a Legacy of Innovation 110 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to ... and a robust pipeline of promising new medicines to help people. Under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the development ... pertain primarily to marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs, in collaboration with Head, Regulatory… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... leadership (including but not limited to clinical Operation, Quality, Regulatory, CMC , and GRDS) to ensure alignment of organizations and prompt resolution… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- **Join a Legacy of Innovation 110 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to ... of promising new medicines to help people. Under the Group 's 2025 Vision to become a "Global Pharma Innovator...incl. coordinating Reg Intelligence & Policy activities with the Regulatory- CMC function and corporate affairs as needed. In the… more
- Bristol Myers Squibb (Cambridge, MA)
- …and make a difference. As part of the Discovery Biotherapeutics efforts at BMS, the Senior Director of Protein Engineering will play a key role in discovering ... and delivering a first-in-class and best-in-class Biotherapeutics pipeline. The Senior Director , Protein Engineering, will be responsible for leading a team of… more
- Bristol Myers Squibb (Warren, NJ)
- …team. **Position Summary:** As the Head of the Cell Therapy Attribute Sciences group , the energetic and motivated Sr. Director will have overall responsibility ... inform the development of manufacturing processes and analytical tools within a CMC technical development function. The dynamic leader will be tasked with… more
- AbbVie (Irvine, CA)
- …Research Group at AbbVie seeks an accomplished scientist and leader. The Director / Senior Principal Research Scientist will lead a team performing in vivo ... development is a required. A key role for the position is partnering with senior management to conceive and provide strategic direction and vision for the program… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , Strategic Sourcing and Supplier Management, Contracting** **KEY ... RESPONSIBILITIES** The Sr. Director , Contracting is accountable for the processes, systems, and...contracting strategy development and negotiations + Develop and oversee group training plans to enhance contract development and negotiation… more
- Sanofi Group (Bridgewater, NJ)
- …CMC / GRA-Devices. Attends HA meetings and collaborates with the regions / GRA- CMC /GRA-Devices to communicate the outcome to senior management as needed + ... May lead Health Authority meetings and preparations as designated + Leads submission team or regulatory sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the… more
- Sanofi Group (Bridgewater, NJ)
- …CMC / GRA-Devices. Attends HA meetings and collaborates with the regions / GRA- CMC /GRA-Devices to communicate the outcome to senior management as needed + ... May lead Health Authority meetings and preparations as designated + Leads submission team or regulatory sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the… more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison / ... a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or Director , in the development & execution of the regulatory… more
- Novo Nordisk (Lexington, MA)
- …through early clinical development. As a primary responsibility, the Medical Director will participate on several cross-functional teams to plan, design, execute, ... interfacing with both internal and external stakeholders including Novo Nordisk senior leadership and external Key Opinion Leaders (KOLs) and Principal Investigators… more
