- 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
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; ... with expertise in parenteral and general pharmaceutical development to guide the CMC and regulatory aspects of development and commercialization. This person is… 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: Nov 9, 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
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their breadth of ... projects while also supervising and mentoring a team of CMC Product Development Directors. A key function of the...the Product Presentation & Device Strategy Team (PPDST) and CMC development plans closely align with the clinical and… 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)
- …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
- 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
- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director has responsibility for ... and projects during lifecycle from development throughout marketing. The GRL CMC Director or Senior Associate Director supports complex, non-standard… more
- Bristol Myers Squibb (Summit, NJ)
- …and experience. **Position Responsibilities** In addition to the general objectives, the GRS- CMC Director is responsible for the following: + Develop and ... lives. Read more: careers.bms.com/working-with-us . **Functional Area Description** The GRS- CMC organization provides regulatory expertise related to CMC … more
- Takeda Pharmaceuticals (Lexington, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently develop and lead the execution ... of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally across the business. **How you will contribute:** + Develops,… more
- J&J Family of Companies (Malvern, PA)
- Johnson & Johnson is recruiting for a Senior Director , Antibody Conjugates, CMC Portfolio Management located in Malvern, PA. This leadership position will lead ... the Antibody Conjugate CMC leaders while also serving as a CMC Leader in TDS supporting and influencing all aspects of the E2E compound development from pre-NME… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Product Development Director (PDD) will be a member of the Operations Strategy & Pipeline ... be responsible for pipeline programs from a Chemistry, Manufacturing, and Controls ( CMC ) perspective. They will lead the Product Presentation and Device Strategy… 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 (Tarrytown, 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 (North Wales, PA)
- **Job Description** 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 accordance with domestic and… more