- AbbVie (North Chicago, IL)
- …Implement well-defined, efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that the CMC ... development strategy and provide drug development experience and advice to the CMC team. Influence development of new regulatory guidance, assure timely impact… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …(including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will serve as the ... Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS- CMC Associate Director , Biologics will assess Manufacturing Change Controls for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will develop ... and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products....CMC team, you will report to a Senior Director and work with stakeholders across the business. **How… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific CMC … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within ... project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with product development, ... flexibility the incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout the product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Regeneron Pharmaceuticals (Troy, NY)
- …preferably related to health, environment or politics or related degree and: + Associate Director : 15+ years of related experience in regulated industry or ... The Director of CMC Industry and Regulatory...The Director of CMC Industry and Regulatory Intelligence is responsible for...into action and influence policy and standards for all CMC operations across Regeneron. As a Director … more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... in nonclinical areas with a focus on Chemistry, Manufacture and Control ( CMC ), expanding and broadening the application of Biostatistics. He/she is also responsible… more
- UTMB Health (Huntsville, TX)
- Associate Director , Laboratory Services - CMC - Estelle Unit **Huntsville, Texas, United States** Clinical Laboratory UTMB Health Requisition # 2400470 The ... supervision for Correctional Managed Care Laboratory Services. Assists the Medical Director in the overall direction and management of Correctional Managed Care… more
- Organon & Co. (Plymouth Meeting, PA)
- …Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist ( Associate Director ) is responsible for Regulatory ... Chemistry Manufacturing & Controls ( CMC ) aspects of clinical phase through market product registration for the assigned portfolio of small molecule, biologic,… 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...capsules, and spray dried dispersions. + Fostering collaboration with CMC , DMPK, Chemistry and Discovery R&D teams + Conducting… more
- UTMB Health (Dickinson, TX)
- Mental Health Clinician - CMC - Carole Young **Dickinson, Texas, United States** Social Service UTMB Health Requisition # 2404113 The mission of Correctional Managed ... Works under the supervision of a Psychologist, Mental Health Manager and/or Program Director . **_ESSENTIAL JOB FUNCTIONS_** **:** + Contributes to the success of the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio...working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Bristol Myers Squibb (Seattle, WA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Associate Director , Cell Therapy Comparability** **Location: Summit, NJ or ... your career, and the ability to help patients are incredible. The ** Associate Director , Cell Therapy Comparability** will lead comparability programs and… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **Objective / Purpose:** + Global CMC program oversight of PS with management of all project-related analytical topics, ... line function strategies, program managements, resources, and budgets + Local CMC program oversight related to analytical development, testing, and characterization,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your...Proposal (RFP) through contract execution for clinical studies and CMC projects as well as ongoing governance with key… more
- Novo Nordisk (Boulder, CO)
- …are driving change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development ... development and scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel strategies towards… more
- Lilly (IN)
- …communities through philanthropy and volunteerism. ** ** **Position Summary:** The Associate Director , Clinical Supply Management has responsibility for the ... clinical supplies across the oncology portfolio. + Communicate with CMC and clinical partners to outline potential risks, limitations,...on time availability of study drug. + Advise the CMC team and clinical partners on strategic options for… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Ensures timely preparation of organized and scientifically valid… more