- Lilly (Indianapolis, IN)
- …life better for people around the world. **Position Summary:** The Associate Director , CMC Project Management will provide strategic and operational leadership ... investment strategy optimization at both project and portfolio level. The Associate Director , CMC Project Management may also partner with the Senior Director… more
- Gilead Sciences, Inc. (Foster City, CA)
- …cancer and inflammation, and serious respiratory and cardiovascular conditions. ** Director , CMC Regulatory Affairs - Biologics** **Key Responsibilities:** ... The Director , CMC Regulatory Affairs for Biologics is responsible for defining...position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC ... diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific CMC … more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , CMC Program Lead, Cell Therapies in Cambridge, MA with ... and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles (project planning, RACI,… more
- Hubbell Power Systems (Hamilton, OH)
- Business Unit Director ( CMC ) - Hamilton, OH Apply now " Date: Oct 11, 2024 Location: Hamilton, OH, US, 45015-1369 Company: Hubbell Incorporated Job Overview ... Responsible for all Product Management and Engineering activities to assigned CMC products to maximize product line gross margin and unit volume growth. Provide all… 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 of CMC Industry and Regulatory Intelligence, a… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Dossier Leadership will lead an experienced team ... responsible for the creation and management of high-quality CMC submission strategies and Module 3 regulatory documents. Reporting...and Module 3 regulatory documents. Reporting to the VP CMC Strategy and Portfolio Leadership, they will act as… 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 ... Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + Leads the… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you will oversee the development and ... Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently plan, execute and manage… 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 ... Oversees the development and execution of strategy by the CMC and Device Regulatory Affairs team for Obesity and...strategic alignment across programs and geographies + Represents the CMC and Device Regulatory Affairs Obesity team with Amgen… more
- AbbVie (Worcester, MA)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing statistical ... 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
- AbbVie (North Chicago, IL)
- …or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule ... + Lead cross-functional S&T product teams and represent the CMC team and/or S&T in interface with S&T leadership,...ownership of the product, process and methods by the CMC team; facilitate the identification and resolution of technical… 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
- AbbVie (North Chicago, IL)
- …the development programs. Key member of Asset Strategy Team (AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. ... May lead multiple PPDST/ CMC teams from GLP tox through IND and cPoC...or DevSci wide initiatives and strategies Leads a global CMC team of functional representatives from various departments and… more
- Lilly (Philadelphia, PA)
- …cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory, manufacturing, and supply chain teams, to ensure seamless ... execution of CMC strategies and activities. + Lead and direct the...FDA, EMA, PMDA, and other global health authorities, for CMC activities. + Collaborate with global partners and external… more
- Regeneron Pharmaceuticals (Troy, NY)
- Leads the Chemistry, Manufacturing, and Controls ( CMC ) non-antibody team for cell and gene therapy technologies. The candidate will be responsible for assuring ... and current policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio of CGT products covering clinical… 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
- Pilgrim's (New York, NY)
- …purchasing organization channels. This role will collaborate directly with the Sr. Director of CMC /GPO to create strategic, integrated customer business plans ... **Description** CMC /GPO Regional Sales Manager - East Purpose and...Pilgrim's within the channel, further develop relationships with key/strategic CMC /GPO accounts, manage the broker & deliver KPIs. +… more
- Merck (Wilson, NC)
- …between the CMC organization and our Manufacturing Division. Reporting to the Sr. Director , Americas Site CMC , this role will support the conformance of our ... The candidate will be part of our company's Global Regulatory & CMC organization supporting the Americas Site CMC team located at the Wilson site. Site CMC … more
- AbbVie (Worcester, MA)
- …Instagram, YouTube and LinkedIn. Job Description Position will be responsible for CMC leadership and project management for existing and new biologics projects from ... the drug substance perspective. Responsibilities: *Develop comprehensive project plans, budgets, timelines and strategy; biologics projects at all stages of development are included, from phase I through commercial. *Must present technical information… more