- BioAgilytix (San Diego, CA)
- …therapeutics to the patients who need them.Join our esteemed team at BioAgilytix as the Director , Business Development , where you will play a pivotal role in ... strong focus on supporting a CRO, CMO, or drug development organization. Working knowledge of selling GMP CMC...biologics and cell and gene therapies is preferred.As the Director of Business Development , your… more
- Merck & Co. (North Wales, PA)
- …the probability of regulatory success together with risk mitigation measures.Lead the development , communication, and review of the CMC Regulatory Strategy ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist /...years of relevant experience including biologics or vaccine Regulatory CMC , or development ; manufacturing, testing, or licensure… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Rahway, NJ)
- …project work, the Associate Director is expected to contribute to ongoing business process improvement and talent development in Global Project and Alliance ... Job Description Job Description: - The drug development Project Manager is part of Global Project...our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early… more
- Merck & Co. (Rahway, NJ)
- …out R&D activities partnering across the network to enable process and formulation development .- In this position the SMAR&D Director will set guidance, lead ... activities, and develop a team whose roles include development of characterization methods to characterize and release clinical drug substance and product and their… more
- Merck & Co. (Rahway, NJ)
- …should have solid understanding of integration and partnering for Pharmaceutical development / CMC with Quality, Regulatory, Operations, Non-clinical, Clinical, ... healthcare. The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics as well as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Program Manager will advance the purpose and aspiration of our ... the Digital Strategy for our organization, comprising of Process Research & Development , Analytical Research & Development , and Pharmaceutical Sciences &… more
- Tris Pharma (Monmouth Junction, NJ)
- …, Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development , R&DDescriptionTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned ... Junction, NJ headquarters has an immediate need for an experienced Associate Director / Director , Analytical Research & Development . Job Title commensurate… more
- Eisai, Inc (Raleigh, NC)
- …meetings, IPT/ CMC meetings, supplier review meetings and interaction with business development partners (where applicable).Works to identify appropriate KPIs ... and oncology, with a strong emphasis on research and development . Our history includes the development of...Tech Ops unit. Works to establish and implement appropriate business plans with the Tech Ops Director ,… more
- Novo Nordisk Inc. (Boulder, CO)
- …With a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and ... The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its...RNAi Early Development professionals at our Boulder, Colorado facility and works… more
- Novo Nordisk Inc. (Boulder, CO)
- …raw materials and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions ... laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality,...measurements that are consistent with the priorities of the business , and that interim reviews are held so that… more
- Merck & Co. (Rahway, NJ)
- …all stages of cell culture process commercialization.Experience in leadership of CMC development teams.Experience authoring technical documentation in support of ... biologics. CCFS supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their breadth ... the Product Presentation & Device Strategy Team (PPDST) and CMC development plans closely align with the... team strategies and plans that align with corporate business objectives. Decision-making will often require assessment and integration… more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Product Development Director (PDD) will be a member of the Operations ... will lead the Product Presentation and Device Strategy Team (PPDST) and build the CMC development strategy for the late-stage assets, aligning with the clinical… more
- AbbVie (North Chicago, IL)
- …functional representatives from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line functions and the ... with respect to science, technology, compliance and cost effectiveness. + Leads CMC development teams for assigned projects: schedules meetings, develops… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and projects during lifecycle from development throughout marketing. The GRL CMC Director or Senior Associate Director supports complex, non-standard ... and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director has responsibility for… more
- Merck (North Wales, PA)
- …of regulatory success together with risk mitigation measures. + Lead the development , communication, and review of the CMC Regulatory Strategy Document ... least ten years of relevant experience including biologics or vaccine Regulatory CMC , or development ; manufacturing, testing, or licensure of biological… more
- Lilly (Indianapolis, IN)
- …global program team/governance and translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC ... to ensure project success. + Support Due Diligence efforts by leading CMC development assessments, and integrate, stakeholder communication regarding key… more
- Takeda Pharmaceuticals (Boston, MA)
- …with international Health Authorities as necessary, directly and indirectly. Provide regulatory CMC expertise for new business development /due diligence ... oversee the development and execution of regulatory CMC development and registration strategies. RA ...process development and enhancement + Evaluate new business development opportunities or participate on due… more
- Takeda Pharmaceuticals (Lexington, MA)
- …GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally across the business . **How you will contribute:** + Develops, ... life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently...years) required. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development … more
