- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …also contribute to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to ... CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation is complete, well… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and a working knowledge of global regulations and guidelines regarding drug development (incl. CMC ), regulatory submissions and corresponding regulatory ... from across functions on key regulatory topics, particularly relating to biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with… more
- Insmed Incorporated (Bridgewater, NJ)
- …record of successfully leading toxicology programs through various stages of drug development.Experience in toxicology on biologics , oligonucleotides, and/or ... record of successfully leading toxicology programs through various stages of drug development.Experience in toxicology on biologics , oligonucleotides, and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …discipline: engineering, science, or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is ... in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategy & Investigations Owner/Lead as part of the Technical Operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …biological science, pharmaceutical science etc. Minimum 5+ years of industrial biologics CMC development or manufacturing experience, Cell therapy manufacture ... treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/Associate Director , External Manufacture as part of the Global Manufacturing Supply team… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …provides subject matter expertise to key internal functions (regulatory, Quality, Clinical, CMC and formulations, Product Quality, Drug safety, Medical affairs) ... new options for patients including novel compounds, small molecules and biologics , and through cannabinoid science and innovative delivery technologies. Jazz is… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …new options for patients including novel compounds, small molecules and biologics , and through cannabinoid science and innovative delivery technologies. Jazz is ... rationale, clinical development, nonclinical development, regulatory, medical, commercial input, CMC , legal and other business strategies. The LDTL provides… more
- Editas Medicine (Cambridge, MA)
- …cross-functional teams in the execution of these submissions. Key Responsibilities: + As the Director , Regulatory CMC , you will be responsible for: + Provide ... health authority meetings. + Accountable for the management and delivery of all CMC regulatory milestones, including global investigational drug filings (eg, IND… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... discipline required, Advanced Degree preferred. + At least 10 years Regulatory CMC experience (vaccines or biologics experience required). Alternatively 5 years… more
- BeiGene (San Mateo, CA)
- …development and manufacturing of biologics . + ≥8 years of industrial experience in CMC of biologics . Experience with cell therapies is a plus. + Broad ... We are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy...GMP batches of cell therapy products. + Responsible for drug product management and generating and reviewing technical reports… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Associate Director ** **; CMC , Device Development Program Manager** **Functional Area: Technical ... empowering cross-functional team members to execute. + Solid understanding of drug development, device development, biologics manufacturing, and global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …work collaboratively with cross-functional stakeholders and contribute to the overall biologics CMC development strategies. **Responsibilities:** + Establish and ... impact. Join Gilead and help create possible, together. **Job Description** The Director of Purification Development for Pre-pivotal Biologics will be… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Executive Director of Cell Culture Development (CCD) will be responsible for leading the ... development and characterization of cell culture processes for biologics programs from the Pivotal and Commercial stages. This responsibility will also include any… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ownership of the strategy, selection, risk, and performance management of CDMOs providing biologics drug product to Gilead. We are seeking a high energy, ... more than 35 countries worldwide, with headquarters in Foster City, California. ** Director , Strategic Sourcing and Supplier Management, Biologics DP** **KEY… more
- AbbVie (North Chicago, IL)
- …ARD partners with all functions across Biologics CMC to deliver high-quality drug products for patients. The Director , Biologics ARD will lead the ... portfolio. + Effectively manage organizational interfaces (Discovery, Small Molecule CMC , Biologics CMC , CMC...required (4+ years). + Proven experience in leading a biologics drug substance and/or drug … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to regulatory process optimizations on relevant topics. **Responsibilities** - Supports CMC regulatory compliance activities for portfolio biologics to meet ... CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation is complete, well… more
- Lilly (Indianapolis, IN)
- …development is a must have. Demonstrated competency, experience, and knowledge in biologics CMC development and compliance requirements from early to late ... Director of Upstream Process Development will oversee the development of drug substance upstream processes for biologics within Lilly's biologics … more
- Bristol Myers Squibb (Cambridge, MA)
- …close collaboration with scientific leaders across the global Research organization and beyond (eg, Biologics Drug Product/ CMC teams) to deliver on our ... a difference. As part of the Discovery Biotherapeutics efforts at BMS, the Senior Director of Protein Engineering will play a key role in discovering and delivering… more
- Lilly (Cambridge, MA)
- …improvements in healthy outcomes for our customers. We are seeking an Executive/Senior Director - DDCS Drug Delivery and New Product Innovation to partner with ... **Additional Skills and Preferences:** + Demonstrated scientific knowledge of Pharmaceutical Drug Discovery, CMC , Clinical Development, and Intellectual Property… more
- Bristol Myers Squibb (Summit, NJ)
- …of analytical strategies to ensure product quality and safety of small molecule and biologics drug substance and drug products and is responsible for ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Analytical Strategy and Operations (ASO) reports to the Vice… more
