- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case ... early and late phase drug development candidates within the team to support overall CMC development plan.- Represent CMC development project teams on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …engineering, science, or related field Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly ... partners and CMOs preferred Extensive knowledge in process and analytical development , technology transfer, process comparability and qualification, CMC … more
- Merck & Co. (Rahway, NJ)
- …science with 10 years of industrial experience with pharmaceutical drug substance and/or product development .Ph.D. in chemistry or related science with 7 years ... of industrial experience with pharmaceutical drug substance and/or product development .Required:Demonstrated ability in leading teams with proven talent … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including (mAb, Drug Substance, Drug Product , or New Modality) process and product development preferred Travel Ability to travel up to 30%. Global and ... activities across the projects for (mAb, Drug Substance, Drug Product , or New Modality) manufacturing, evaluates CMC ...and associated teams for internal and external sites and development projects. Serve as the main interface to internal… more
- Merck & Co. (Rahway, NJ)
- …of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... culture of innovation across modalities and will partner with cross-functional development teams to enable pipeline decisions.- The Director , Biologics… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …engineering, science, or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly ... immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part of the… more
- Aequor (Thousand Oaks, CA)
- …large and/or small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and ... and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for...annual product review) in support of the Product Development Team (PDT). The PQL provides… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , CMC Digital Product Development where you will be tasked with ... Engineering, and the Emerging Technologies team to help digitize our process development , analytical development , and manufacturing work flows and enable… more
- AbbVie (North Chicago, IL)
- …with respect to science, time, budget and resources. + Develops and implements a CMC product development plan and updates as necessary in collaboration ... thinking and make smart business decisions. *Ensure high level of morale in the CMC team. Product development experience of leading a CMC team through… more
- AbbVie (North Chicago, IL)
- …technology, quality, regulatory/compliance requirements, budget and resources. *Multiple product development experiences of leading a CMC team through IND ... from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line...needed. + Critically evaluates and integrates drug substance, drug product , and device inputs to CMC team… more
- AbbVie (North Chicago, IL)
- …experience; PhD Degree with at least 10+ years of relevant experience. + CMC development experience through IND and/or NDA/MAA/BLA. Experience leading multiple ... about the accountability and scope. + Lead cross-functional PDS&T product teams and represent the CMC team...Bachelor 's Degree with 14+ years of relevant experience ( CMC , sterile manufacturing/ development ); Master's Degree with 12+… more
- Teva Pharmaceuticals (West Chester, PA)
- … Director , Regulatory Affairs CMC is responsible for identifying and evaluating CMC issues associated with product development including product ... formulation development , manufacturing, and labeling. The Sr Director , Regulatory Affairs CMC is also responsible...regulatory departments. The Sr Director , Regulatory Affairs CMC will oversee cross functional product teams… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Read more: careers.bms.com/working-with-us . The CMC Regulatory Associate Director , Biologics is responsible for content development , compilation, ... and Global Product and Supply (GPS). The GRS- CMC Associate Director , Biologics will assess Manufacturing...Summary / Objective** The CMC Regulatory Associate Director , Biologics is responsible for content development ,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in small molecule product development , global CMC regulatory affairs, and CMC ... countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY...of CMC RA colleagues to drive global CMC regulatory strategy development for a portfolio… more
- Takeda Pharmaceuticals (Boston, MA)
- …organization to think proactively and utilize science and risk based approach to product development and LCM activities. + Contribute to creating and ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...Pharmaceuticals. **How you will contribute:** + Leads the Early Development Pharmaceuticals GRA CMC regulatory team in… more
- Editas Medicine (Cambridge, MA)
- …including but not limited to developing regulatory strategy and plan for CMC development , assessing regulatory scenarios risks and opportunities, proposing risk ... functional teams to provide regulatory guidance and support for CMC development and ensure compliance with applicable...is preferred. + A broad understanding of the drug product development process is required. + This… more
- Lilly (Philadelphia, PA)
- …standards, and cost targets. + Collaborate with cross-functional team leaders, including development , CMC regulatory, manufacturing, and supply chain teams, to ... radiopharmaceutical development and manufacturing and incorporate them into the CMC strategy. + Mentor and develop team members, providing coaching and feedback… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case ... early and late phase drug development candidates within the team to support overall CMC development plan. - Represent CMC development project teams… more
- Sanofi Group (Framingham, MA)
- …to support the CMC activities for process, analytical methods and formulation development , in the US, across our Boston area sites. Your skills could be critical ... applied to process development activities. + Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good… more
- BeiGene (Emeryville, CA)
- …cell therapy development . Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will ... cell therapies is a plus. + Broad understanding of all aspects of CMC including process development , regulatory and quality requirements, analytical … more
