- 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
- 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)
- Job Description Job Description: End-to-End Technical Product Leadership:- Development and Commercialization Team (DCT) Leader Role in Small Molecule Global Science, ... Engineering, & Commercialization (SM GSEC) The Director , DCT Leadership position in the Manufacturing Division is...responsibilities, as it entails guiding drug product candidates from development to launch in line with enterprise priorities.- As… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality assurance and ... regulatory CMC for complex medical devices, including auto-injectors and other...device quality throughout the product lifecycle, from design and development to commercialization. The individual will also manage the… more
- Merck & Co. (Rahway, NJ)
- … development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible ... portfolio of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists.… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product ... pipeline.The Director will report to the Executive Director of Sterile Product Development - Mixed...knowledge of FDA, ICH, and other regulatory requirements for CMC , and demonstrated experience partnering for Pharmaceutical development… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: Director (M3), Analytical External Capabilities, Validation & Compliance (ECVC).The selected candidate will work in the Analytical ... Research & Development (AR&D) department within the Development Sciences...in a fast-paced and dynamic environment.Strong knowledge of Biologics CMC landscape including knowledge of GMP and relevant HA… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Title - Director / Principal Scientist, Regulatory Compliance Department - Device Quality & Regulatory Brief Description of Position- This ... final guidance and standards.Provide strategic advice to senior management on CMC regulatory matters based on health authority feedback and global regulatory… 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
- 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
- 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 ... molecules and oligonucleotide products. Relationships This position reports to Senior Director , Chemical Development . Essential Functions Lead the development… more
- Tris Pharma (Monmouth Junction, NJ)
- … development , clinical development , regulatory, CMC ) and business (eg, business development , alliance management, commercial) functions.Drug ... and succinct manner with Tris leadership and other functions. Support Business Development . Support expanding existing partnerships or other out-licensing… 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
- 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)
- …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
- 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
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... into action and influence policy and standards for all CMC operations across Regeneron. As a Director ...development and commercialization process, with a focus on CMC + Experienced in understanding and interpreting regulatory guidelines… 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 ... development candidates within the team to support overall CMC development plan. - Represent CMC...operational teams, other functions in Technology Unit, and key business partners. - Requires preparation and presentation of comprehensive… more
