- AbbVie (South San Francisco, CA)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Position Description: For the Biologics Drug Product R&D Director position, we are ... experience levels and must foster productive collaborations within the global Biologics Drug Product Development organization and with R&D cross-functional… 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
- 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)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Executive Director of Cell Therapy Vector Operations will report to the Vice President ... CTDO Division as we prepare to commercialize autologous cellular biologics to overcome tumor evasion and potentially eradicating cancer...strategies, and standards for both the Vector and CAR-T drug product. The head is expected to hire, develop… more
- Bristol Myers Squibb (New Brunswick, 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
- 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
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... leadership (including but not limited to clinical Operation, Quality, Regulatory, CMC , and GRDS) to ensure alignment of organizations and prompt resolution… more
- Sanofi Group (Bridgewater, NJ)
- …the global regulatory environment and updating of standards and processes related to drug and biologics regulations + Ensure that respective regulatory team ... of global HA interaction strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with the regions / GRA-… more
- Sanofi Group (Bridgewater, NJ)
- …the global regulatory environment and updating of standards and processes related to drug and biologics regulations + Ensure that respective regulatory team ... of global HA interaction strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with the regions / GRA-… more
- University of Southern California (Los Angeles, CA)
- …release and comparability testing. + Creates Chemistry, Manufacturing, and Control ( CMC ) documentation for Investigational New Drug (IND) applications. Develops ... cGMP Associate Director Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP-Associate- Director -Process-Development\_REQ20129819/apply) Keck… more
- BeiGene (Emeryville, CA)
- …strategies to mitigate risks and support development of small molecule and/or biologics drug candidates from pre-IND and first-in- human testing through ... **_General Description:_** + The Director , Clinical Pharmacology will be responsible for developing...pharmacology and pharmacometric strategies for novel small molecules and biologics assets in the company portfolio. She/He will provide… more