- 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
- 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
- Merck & Co. (Rahway, NJ)
- …Finance, Regulatory, Quality, Compliance, Supply Chain and Commercial.Understanding of product development lifecycle and integration of CMC and clinical strategy ... of brand operating metrics. The VCM PL will partner with the Product Development Team (PDT), Development and Commercialization Team (DCT), and Global Brand… 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
- Merck & Co. (North Wales, PA)
- …leader will interact with our company cross-divisional/functional teams from development through commercialization to ensure implementation of the designed quality ... Management processes and Regulatory Compliance plan in support of early-stage development to commercialization of New Modalities products.Work in partnership across… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the ... other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other departments including… 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
