- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...of API and preclinical formulations + Fostering collaboration with CMC and Discovery R&D teams + Conducting development studies,… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Mar 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. ** Senior Advisor/ Director , Global Regulatory Affairs - CMC , Small Molecules** At Eli Lilly, we ... new medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in accordance with domestic… 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 ... the project leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support for market registrations… 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 ... to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for … 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...available to patients in markets as needed. The Executive Director of CMC Pre-approval Pharm holds responsibility… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA ... CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you will… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Sr . Director , Statistical Programming provides technical leadership to portfolio ... delivery and building / retaining highly skilled talent in Statistical Programming. Sr . Director , Stats Programming, proactively creates and implements delivery… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose** : The purpose of the Sr . Director role in Global Regulatory Affairs (GRA) - Drug Delivery and Digital ... clinical trials and market clearance/registrations. It is necessary for the Director to develop collegial and mutually productive relationships across Lilly, partner… 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 ... Preferences:** + Demonstrated scientific knowledge of Pharmaceutical Drug Discovery, CMC , Clinical Development, and Intellectual Property Processes. + Experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The ... Sr Director , Analytical Regulatory Science, is responsible for supervising a...incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA Pharmaceuticals- Small Molecule where you will establish ... trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy....CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -… more
- Gilead Sciences, Inc. (Foster City, CA)
- …. Manager, SSSM, Mfg. Consumables and Excipients will normally be under the direction of a Sr . Director or Director of SSSM. This includes ownership of the ... management processes + Responsible, under the direction of a Sr . Director or Director of...management software + Understanding of activities related to the CMC development of biopharmaceuticals + Knowledge of GMPs and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
- Editas Medicine (Cambridge, MA)
- …and distribution of non-GMP materials at all locations. Key Responsibilities: As the Sr . Director , Supply Chain, you will be responsible for: + Building ... and Technical Operations and partner with leadership in TechOps, ClinOps, Finance, CMC and Program Teams to lead short-term integrated production and raw materials… more
- Bristol Myers Squibb (Warren, NJ)
- …the Head of the Cell Therapy Attribute Sciences group, the energetic and motivated Sr . Director will have overall responsibility for leading the development of ... development of manufacturing processes and analytical tools within a CMC technical development function. The dynamic leader will be...care resources. Other perks like tuition reimbursement and a recognition program. If you come across a role that… 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...management systems + Understanding of activities related to the CMC development of biopharmaceuticals + Knowledge of relevant GMPs… 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 ... (including but not limited to clinical Operation, Quality, Regulatory, CMC , and GRDS) to ensure alignment of organizations and...mitigation plans by working with supply chain leaders and CMC project managers. + Act as point of escalation… 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