- Integra LifeSciences (Plainsboro, NJ)
- …applicable regulatory agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** ... what's possible and making headway to help improve outcomes. This ** Senior Manager, Quality Operations** will manage and provide oversight on Quality … more
- Lilly (Philadelphia, PA)
- …+ Collaborate with global partners and external vendors to ensure timely and quality delivery of CMC activities. + Drive continuous improvement initiatives to ... and supply novel PET radiopharmaceuticals, ensuring adherence to timelines, quality standards, and cost targets. + Collaborate with cross-functional team… 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...late-stage process development is strongly preferred + Experience with quality by design (QbD), process validations and statistical design… more
- Integra LifeSciences (Plainsboro, NJ)
- …headway to help improve outcomes. **SUMMARY** Under the direct supervision of the Director , Quality Reliability Microbiology, this individual will have a dotted ... line reporting structure to the local site quality leader. Responsibilities associated with this Sr . Microbiologist include interpreting microbiological testing… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule where you ... CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -...time. + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … 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)
- …GLOBAL REGULATORY CMC Biologics (R5)** 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… more
- Regeneron Pharmaceuticals (Troy, NY)
- …: 18+ years of related experience regulated industry or health authority + Senior Director : 20+ years of related experience regulated industry or health ... The Director of CMC Industry and Regulatory...Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance excellence by ensuring… more
- Astellas Pharma (Westborough, MA)
- …revenue, and/or credibility. **Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** ... Technology, Quality Assurance, Business Partners). Responsible for developing global CMC regulatory strategy (eg, CMC strategy/planning for NMEs), driving… more
- Bristol Myers Squibb (Seattle, WA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr . Manager / Associate Director , Global Sterility Assurance CTTO** ... at BMS with our Cell Therapy team. T he ** Sr Manager/Associate Director - Sterility Assurance, Cell...Cell Therapy . + Experience with regulatory inspections and CMC + Experience with Quality Management System.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Biologics Drug Product MSAT** Gilead Sciences, Inc. is ... with internal/external stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development,… more
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual for a newly created Director / Senior Director role in Process Chemistry in Frontier's South San ... scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to support all development… more
- Lilly (Indianapolis, IN)
- …changes in timeline, objectives, or direction. + Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality , Manufacturing, ... utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges + Lead and/or supervise the design and development of new… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …life-changing therapies to patients worldwide. **How you will contribute:** + The Senior Director , Pharmaceutical Sciences (PS) Portfolio Leader is accountable ... as managing & developing a high functioning team of senior PS program leaders that lead a significant portion...PS / R&D and the commercial organizations + The Sr . Director , PS Portfolio Leader is a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …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...content and changes. + Evaluates and communicates risks for CMC control strategies and quality compliance to… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Clinical Development - Respiratory Date: Aug 31, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job ... be based in Parsippany, NJ or West Chester, PA Senior Director , Clinical Development is responsible for...Brochures, clinical study reports, summaries for regulatory submissions). The Sr . Director , Clinical Development will provide input… more
- Takeda Pharmaceuticals (Boston, MA)
- …all stages of analytical development and understand the global regulatory trends for CMC activities, to ensure robust and high- quality regulatory filings in all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … and right first time + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations, with emphasis on Material Sciences, ... changing regulations and guidance documents; and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy of Material… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs, Global Regulatory Lead ... and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC , GRA-Devices, and regional regulatory scientists) and is responsible for forming… more