- 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
- Merck (Rahway, NJ)
- …while developing and expanding your career. The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable for managing a ... molecules to peptides, pediatric formulations, and devices. The Executive Director , as a senior member of the...CMC regulatory strategy and plan for the assigned group of projects/products. + Effectively communicates CMC … 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 (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)
- …Gilead and help create possible, together. **Job Description** **Key Responsibilities:** Senior Director , Global External Manufacturing, Biologics will lead an ... legislations. This position is part of the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization...A proven capability to contribute to the success of CMC functions as a senior leader +… 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 (Framingham, MA)
- …Development department within CCD located in Framingham, MA in the role of Associate Director . We are looking for a candidate with excellent scientific, CMC , ... of upstream scientists and lead cross-functional projects. As a senior staff member of Commercial Cell Culture Development, this...Pursue IP opportunities for the company. + Lead a group of scientists focused on upstream process development and… 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
- Novo Nordisk (Boulder, CO)
- …and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions + The ... 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
- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . The Executive Director , CT Technical Operations Drug Product will have global responsibility in ... therapy global manufacturing network. This role collaborates with Manufacturing, CMC , Regulatory, SC, Quality, QC, F&E, Process Development, Analytical Development,… more
- BeiGene (San Mateo, CA)
- **_General Description:_** + The Director , Clinical Pharmacology will be responsible for developing and executing clinical pharmacology and pharmacometric strategies ... other key functions such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc. Responsibilities will include planning and reviewing study designs &… more
- Lilly (Cambridge, MA)
- …significant improvements in healthy outcomes for our customers. We are seeking an Executive/ Senior Director - DDCS Drug Delivery and New Product Innovation to ... fields along with key external innovation subject matter authorities. Together this group will own new investments in delivery and device technologies that span… more