- Insmed Incorporated (NJ)
- …patients, for each other, and for the future of science, we're in. Are you?About the Role:The Sr . Director CMC QA will lead QA CMC oversight for drug ... every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr . Director of Toxicology as part of the Clinical Development … more
- Insmed Incorporated (NJ)
- …every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, ... personnel and internal cross-functional stakeholders across disciplines of Manufacturing, CMC , Quality, Legal, Procurement and Finance. The ideal candidate would… more
- Programmable Medicine Operatin (Redwood City, CA)
- …stage biopharmaceutical company located in Redwood City, is seeking a motivated Chemist/ Sr . Chemist Analytical Method Development . We are focused on developing ... diseases with unprecedented precision. This position reports to the Director , Analytical Research and Development and will...writing experience such as protocols, reports, SOPs, and preparing CMC sections of IND. *Knowledge of GLP & GMP… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes… more
- Formation Bio (New York, NY)
- …patent and IP portfolio, where you will work closely with our business development , legal, clinical, CMC , and data/engineering teams to on-board products with ... features Comfortable working cross functionally, including partnering with clinical and CMC teams to identify patentable innovations during development ,… more
- Merck & Co. (Rahway, NJ)
- …late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics ... portfolio of approximately 3-6 programs at various stages of development . The key accountabilities include managing the work and...The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in… more
- Jobleads-US (New York, NY)
- Overview Reporting to the Senior Director , HRBP, the HR Business Partner (HRBP), R&D serves both as a strategic and operational partner supporting the Oncology ... to Detail Organizational Skills Business Acumen. Base Salary Ranges: Senior Manager: $118,000-$153,000 Associate Director : $150,000-$190,000. Menarini Stemline… more
- Insmed Incorporated (San Diego, CA)
- …teams and senior leadership, as neededCollaborate with Clinical Development , Clinical Operations, CMC , QA/QC, Nonclinical, Program Management, and ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for...future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader… more
- Merck & Co. (Rahway, NJ)
- … development process & connectivity between functions supporting pipeline (ie clinical development , CMC , supply chain, & human health), and balancing needs of ... The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.- - The… more
- Endo International (Horsham, PA)
- …we serve live their best life. **Job Description Summary** The Associate Director , Manufacturing Operations will provide leadership and management of operations at ... including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership team and works… more
- BeOne Medicines (San Mateo, CA)
- As Director of R&D Data Enablement / Data Products, you will lead the strategy and execution of building and scaling R&D data foundations and data products that ... internally defined ontologies / standards) embedding FAIR data principles. **Data Product Development ** + Build a portfolio of high-value data products that address… more
- CSL Behring (Waltham, MA)
- …therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The job is in our Waltham MA ... onsite three days a week. You will report to the Executive Director Head Regulatory. **Position Description** **Summary** -Regulatory leaders who support … more
- BeOne Medicines (Emeryville, CA)
- **General Description** **:** The Manager, Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving ... guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and Regulatory Technology teams. While Regulatory Operations manages… more
- Boehringer Ingelheim (Ridgefield, CT)
- …leading all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director / Senior Associate Director ... an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at our Ridgefield, CT… more
- Amgen (Washington, DC)
- …modeling for CMC development and commercial support. Reporting to the Senior Director , CMC Statistics, you will drive innovation in kinetic modeling, ... CMC data, spanning drug substance, drug product, and delivery device development . As Director , CMC Modeling & Advanced Statistics, you will: + Provide… more
- Danaher Corporation (Fargo, ND)
- …management of already established contracts and project/program execution. This position reports to the Director of Drug Product CMC and is part of the Drug ... of life. At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will provide ... therapeutic areas to translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC teams. + Lead… more
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage ... based upon global regulatory changes. + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product… more
- Lilly (Indianapolis, IN)
- …a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval ... life-changing new medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - … more
