- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Director - CMC Regulatory will leverage CMC technical knowledge and ... regulatory strategies for investigational and commercial radiopharmaceutical products. + Lead global CMC regulatory submissions including authoring, review, and… more
- AbbVie (North Chicago, IL)
- …assure timely impact assessment, and implementation of new regulatory requirements. Will lead CMC Coordination activities for later stage and more complex ... interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of sections of … more
- BeOne Medicines (San Mateo, CA)
- …and process optimizations on relevant topics. **Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well ... CMC regulatory strategies for the assigned projects. + Lead regulatory risk assessment, identify key CMC ...+ Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director - CMC BioDPDM **Location**...MA As Associate Director within CMC BioDPDM, you'll have the opportunity to lead ... could turn the impossible into possible for millions. The Associate Director role is a key leadership...Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will… more
- Organon & Co. (Jersey City, NJ)
- …**The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and implementing ... with global regulations and guidance, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) -...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The ... Digital Health **Location:** Cambridge, MA/ Morristown, NJ **About the Job** GRA Device Lead ( Associate Director ) - Digital Health Are you ready to shape the… more
- AbbVie (Irvine, CA)
- …elucidation) for a comprehensive understanding of the product structure-function relationship. + Lead CMC analytical development with in-depth knowledge of a ... join us as a Group Leader based in Irvine, CA reporting to the Director , PDS&T Toxins. Responsibilities: + Manage the protein characterization group by working with… more
- AbbVie (North Chicago, IL)
- …and efficient operations and maintenance of AbbVie's automated laboratory systems. Lead the daily operation of automation capabilities through continuous systems ... automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, work with… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **Title: Process Engineer Small Molecules API Process Science ( Associate Director )** **Location: Cambridge, MA (Hybrid)** **About the role:** ... As a Process Engineer Small Molecules API Process Science ( Associate Director ), you will provide process engineering support in batch or continuous API platforms… more
- Takeda Pharmaceuticals (Lexington, MA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for ... Takeda's manufacturing network and external CMOs. **How you will contribute** + Lead the Small Molecules API Manufacturing Sciences activities within Global Process… more
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- Job Title Associate Director , Manufacturing Operations Requisition JR000015470 Associate Director , Manufacturing Operations (Open) Location Horsham, PA ... Additional Locations Job Description Summary Job Description The Associate Director , Manufacturing Operations will provide leadership and management of… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance ... for the general medicines portfolio of products marketed worldwide. The Associate Director , Biopharmaceutics will also be responsible for contributing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Process & Operational Excellence (OpEx), and part of the larger PDM organization, the Associate Director , Business Processes & OpEx will support the success of ... than 35 countries worldwide, with headquarters in Foster City, California. ** Associate ** ** Director , PDM Business** **Process &** **Operational Excellence**… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Responsibilities:** The Associate Director - API EM Engineering Leader for Peptides ... Molecule is a member of the API EM Plant Lead Teams providing leadership and expertise to reliably supply...Direct or indirect experience with commercialization (Validation, Tech Transfer, CMC , GMP, Quality, and/or HSE) + Demonstrated ability to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Strategic Sourcing & Supplier Management, Medical Devices ... operations team members for recurrent or chronic performance issues with supplier. + Lead annual business review meetings (BRMs) with assigned suppliers as needed + … more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , Drug Product Manufacturing Science & Technology, you will be ... subject matter expert for small-molecule drug product and packaging. You will lead how tablets, capsules, and injectable products are industrialized, transferred to… more
- Takeda Pharmaceuticals (Boston, MA)
- …DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), ... and the life cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls… more
- University of Southern California (Los Angeles, CA)
- …cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all ... in professional organizations, meetings, conferences, seminars, and training courses. + Lead process development and optimization efforts of cell therapy products,… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The ME&C Associate Director is a global program management expert responsible ... projects across disciplines and multiple manufacturing locations. They organize and lead high-performing cross-functional teams in the planning and execution of… more
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