- 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Functional Area Description** The GRS- CMC organization provides regulatory expertise related to CMC ... stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the strategies in… more
- J&J Family of Companies (Malvern, PA)
- Johnson & Johnson is recruiting for a Senior Distinguished Scientist, CMC and Innovation Leader role based in Malvern, PA with the option of being remote. This ... & Supply (TDS) and will lead one or more radioligand therapy CMC programs in TDS as a CMC Leader. As a matrix leader, will support and influence all aspects… more
- AbbVie (Irvine, CA)
- …be responsible for pipeline programs from a Chemistry, Manufacturing, and Controls ( CMC ) perspective. They will lead the Product Presentation and Device Strategy ... Team (PPDST) and build the CMC development strategy for the late-stage assets, aligning with...and aesthetic). The PDD is accountable for creating a CMC development plan in collaboration with line functions and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …is seeking a dedicated and innovative Director/Senior Associate Director, Global Regulatory Affairs CMC for Chemical products to join our dynamic team. As a global ... programs reflect Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director has responsibility for the strategic global… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Portfolio Strategy and Integration team is dedicated to developing and executing CMC strategies for small molecule and biologics portfolio utilizing the brightest ... we provide valuable project information and portfolio insights, and we lead CMC due diligence for business development opportunities. Joining PSI means you'll have… more
- Lilly (Indianapolis, IN)
- …the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control ( CMC ) scientists to join us in developing and bringing life-changing new medicines ... all over the world. We are seeking Regulatory Scientist GRA- CMC to be a part of the Lilly global...you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support… more
- Merck (North Wales, PA)
- …responsible for developing and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in ... responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. The...are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their breadth of experience to drive best-in-class ... 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
- Organon & Co. (Plymouth Meeting, PA)
- …(Associate Director) is responsible for Regulatory Chemistry, Manufacturing and Controls ( CMC ) aspects of clinical phase through market product registration for the ... internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and initial product… more
- Takeda Pharmaceuticals (Lexington, MA)
- …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 regulatory ... CMC investigational, registration and/or pos-approval strategies for assigned products...registration and/or pos-approval strategies for assigned products as GRA CMC Product Lead. Represents and contributes to Regulatory, Pharmaceutical… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of ... regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical… more
- BeiGene (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions to meet aggressive timelines. The individual will ... provide support to cross-functional teams on regulatory CMC strategies. **Essential Functions of the job:** + Develop...the job:** + Develop and implement small molecule regulatory CMC strategies as well as author CTD 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
- Eurofins (Indianapolis, IN)
- …strategies and submissions in support of clinical trials. This position utilizes CMC technical knowledge to drive internal consistency and influence effective change ... not limited to: + Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions + Takes a proactive role in the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …create possible, together. **Job Description** **Sr Associate, Regulatory Affairs, CMC ** **Foster City, California** **Responsibilities:** + Develop and manage ... with limited management supervision. + Represent Regulatory Affairs (RA) CMC on product development and life-cycle management teams to identify… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Position Summary:** The Associate Director, CMC Project Management will provide strategic and operational leadership for ... cross-functional CMC team(s) and will partner closely with the scientific...closely with the scientific and technical leaders of the CMC team, who are accountable for technical deliverables. … more
- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Staff CMC Regulatory Sciences Specialist for our CMC Regulatory Sciences team. We are seeking a highly motivated and ... experienced regulatory professional responsible for overseeing CMC aspects of global submissions. This position would focus on initial commercial applications,… 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
- 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 to… more
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