- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within ... based on the 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a ... manufacturing plans at the site which are aligned with cross-functional CMC strategic discussions. Manage timelines, deliverables, and coordinate the input of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part ... science, or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable. Extensive… more
- Aequor (Thousand Oaks, CA)
- …chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as the Product Quality ... resolution of issues associated with process/manufacturing, in process controls, analytical methods, specifications, reference standards, importation testing, investigations, change… more
- Genmab (Remote, OR)
- …our purpose. We are looking for a highly motivated and collaborative Associate Director , Medical Writing. This is and individual contributor/technical position, ... not people-management position. As Associate Director , Medical Writing, you will serve as an expert Medical Writer who is responsible for planning, developing,… more
- WuXi AppTec (Philadelphia, PA)
- …product projects, ensuring timely and high-quality delivery **Responsibilities** * Provide analytical CMC -related support for new working order signing at ... qualification protocols and reports etc. * Author and support the analytical CMC section for IND/IND amendment/BLA application documents for the target country,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with ... and quality teams on the construction, documentation and defense of the analytical control strategies in regulatory submissions preparation and review. By balancing … more
- Sanofi Group (Framingham, MA)
- …team is seeking an expert data scientist / Statistician to support the CMC activities for process, analytical methods and formulation development, in the ... more specifically the Statistics department for the Chemical Manufacturing Control ( CMC ) of biological products ( CMC -Biologics Statistics), is responsible for… 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 ... based on the 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… more
- AbbVie (North Chicago, IL)
- …management approach; Key member of Asset Strategy Team (AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. ... PoC and transfer to commercial manufacturing sites. Accountable for creating a CMC development plan in collaboration with line functions and the Asset Strategy… more
- Teva Pharmaceuticals (West Chester, PA)
- …4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible for identifying and evaluating CMC ... Senior Director Regulatory Affairs CMC (Biologic Products)...product development including product and process development, device development, analytical methods, formulation development, manufacturing, and labeling. The Sr… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , CMC Digital Product Development where you will be ... the Emerging Technologies team to help digitize our process development, analytical development, and manufacturing work flows and enable cross-functional access to… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **_Objective / Purpose:_** As an Associate Director in Analytical Development, it is expected that the ... Quality by Design (AQbD) + Experience in reviewing and approving analytical -related CMC sections of BLA/MAA regulatory submissions. Knowledgeable in European,… more
- Takeda Pharmaceuticals (Boston, MA)
- …relevant industry experience + Minimum of 7 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug ... to the best of my knowledge. **Job Description** **OBJECTIVES** **:** + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of… more
- Takeda Pharmaceuticals (Boston, MA)
- …review. As part of the Analytical Development team, you will report to Associate Director , Analytical Development. **How you will contribute:** + Develop ... a variety of method development, validation, and transfer; Ability to design and direct analytical strategy to meet CMC project objectives + Able to coordinate… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director of Protein Production where you will be an inspirational, ... the production with close communication and collaboration with the analytical team to ensure robust production of high quality... Sciences team, you will report to the Senior Director of the team and work with the Global… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director of Drug Substance - EACD will have the primary responsibility to oversight process development and manufacturing ... manufacturing activities of clinical/commercial stage small molecule APIs. Reporting to the Director of EACD, this individual will provide guidance to the external… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Cell Therapy Decisional Analytics - 2406185128W **Description** Johnson & Johnson is recruiting an Associate Director , Cell Therapy ... We are looking for an energetic and highly motivated Associate Director candidate with demonstrated expertise in...the development and use of a variety of rapid analytical approaches to support cell therapy and lentiviral vector… more
- Novo Nordisk (Watertown, MA)
- …Chemical Development - Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality Assurance, ... of cGMP requirements and regulations for clinical and commercial CMC drug development + Proficiency with typical analytical... CMC drug development + Proficiency with typical analytical tools (NMR, UV, IR, HPLC, MS) + Ability… more
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual for a newly created Associate Director role in Process Chemistry in Frontier's South San Francisco ... 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
