- Gilead Sciences, Inc. (Foster City, CA)
- …cancer and inflammation, and serious respiratory and cardiovascular conditions. ** Director , CMC Regulatory Affairs - Biologics** **Key Responsibilities:** ... Gilead and help create possible, together. **Job Description** Gilead Sciences , Inc. is a research-based biopharmaceutical company that discovers,...The Director , CMC Regulatory Affairs for Biologics is responsible for defining… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... into action and influence policy and standards for all CMC operations across Regeneron. As a Director ...position, you must hold a bachelor's degree in life science , preferably related to health, environment or politics or… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where you will ... CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -...relationships through active partnering with key internal (GRA, GRA CMC , Pharmaceutical Sciences , GMS, GQ etc.) and… more
- Amgen (Thousand Oaks, CA)
- …us and transform the lives of patients while transforming your career. **Regulatory Affairs Director - Global CMC ** **What you will do** Let's do this. Let's ... happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges...Oversees the development and execution of strategy by the CMC and Device Regulatory Affairs team for Obesity and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within… more
- AbbVie (North Chicago, IL)
- …to science , technology, compliance and cost effectiveness. + Leads CMC development teams for assigned projects: schedules meetings, develops agendas, issues ... CMC experience required to effectively manage global teams and all CMC activities with respect to science , technology, quality, regulatory/compliance… more
- AbbVie (Boston, MA)
- …improvements, and drug substance tech transfers. Responsibilities: + Lead cross-functional CMC team(s) in authoring sections of regulatory documents, including INDs ... management. + Drive alignment with key business stakeholders including Development Sciences , Quality Assurance, Regulatory Affairs and others at the Director… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA… more
- Actalent (Gaithersburg, MD)
- …+ Must be located in EST time zone Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary teams (eg ... CMC Teams, Program Teams) and with business partners such...Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies… more
- Frontier Medicines (South San Francisco, CA)
- 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...a strong candidate: + PhD. in Pharmaceutical Chemistry, Materials Science , Analytical Chemistry with 5+ years, MSc. with 8+… more
- Astellas Pharma (Westborough, MA)
- …and/or credibility. **Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** + BS in ... more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal ... Director ) is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) aspects of clinical phase through market product registration for the assigned… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and life cycle management with a focus on Material Sciences (including biocompatibility, extractables and leachables, material attributes, etc.), ensuring ... and right first time + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations, with emphasis on Material Sciences ,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …create possible, together. **Job Description** **Associate Director , Analytical Regulatory Sciences , Systems & Operations in CMC Reg Affairs:** **_*This is ... a site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science , collaborates with product development, manufacturing… more
- Integra LifeSciences (Plainsboro, NJ)
- …regulatory agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** Manages personnel ... skill, and/or ability required for this position. + BS degree in life science or engineering and minimum 8 years in progressive experience in Medical Device… more
- Integra LifeSciences (Plainsboro, NJ)
- …to help improve outcomes. **SUMMARY** Under the direct supervision of the Director , Quality Reliability Microbiology, this individual will have a dotted line ... Microbiology, and Sterility Assurance department and working with the ** CMC Plainsboro, NJ** Integra manufacturing site. Qualified candidates must possess… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory** ** Science ** **KEY** **RESPONSIBILITIES** The ... Gilead and help create possible, together. **Job Description** _Gilead Sciences , Inc. is a biopharmaceutical company that has pursued...Sr Director , Analytical Regulatory Science , is responsible for supervising a team of scientists,… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Pharmaceutical Sciences Program Leadership where you will be responsible ... Sciences Early-Stage Portfolio team, you will report to Pharmaceutical Sciences ( CMC ) Early-Stage Portfolio Leader and mentor and cultivate best practices in… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …therapies to patients worldwide. **How you will contribute:** + The Senior Director , Pharmaceutical Sciences (PS) Portfolio Leader is accountable for both ... / R&D and the commercial organizations + The Sr. Director , PS Portfolio Leader is a member of the...affairs + Has knowledge of fundamental understanding in Clinical Sciences , Regulatory CMC , DMPK, Pharmacology and Toxicology… more
- Lilly (Indianapolis, IN)
- …This individual will serve as the Site Leader for the Technical Service/Manufacturing Science (TS/MS) Department which is focused on the technical aspects of Site ... product, process validation, process controls, compliance, continuous process optimization, CMC regulatory support, manufacturing data analysis and process data… more