- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall … more
- Merck & Co. (North Wales, PA)
- Job Description Position Description: Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease The Regulatory Affairs Headquarters ... Associate Principal Scientist supports products in the Vaccine and...and collaboration skills and will work closely with a global liaison(s) to help develop and implement a … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Merck & Co. (Rahway, NJ)
- …to process validation and commercial launch.- This role reports into the Associate Vice President, Sterile Products Development. This role is located in Rahway, ... in human through line of sight to commercial productionOversee and review CMC authoring activities for DP manufacturingEnsure successful and effective technology and… more
- Novo Nordisk Inc. (Boulder, CO)
- …and external suppliers to ensure a smooth and timely delivery. Relationships Associate Director of Amidite Manufacturing. Owner of business relationships with ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- AbbVie (North Chicago, IL)
- …through regular communications and periodic reviews throughout development and in support of global filings and approvals. + Represents all CMC areas on the ... of global filings. + Responsible for the global filings of high quality CMC dossiers,...for the global filings of high quality CMC dossiers, approvals and commercialization of products. Qualifications *Bachelor's… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall … more
- AbbVie (North Chicago, IL)
- …quality and analytics is required. + Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. Ability to influence ... or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule… more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and ... Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible for...for Teva products, and for ensuring the quality of CMC response to global health authorities. The… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio… more
- Organon & Co. (Jersey City, NJ)
- …accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC ... **Job Description** **The Position** The Associate Principal Scientist is responsible for developing and...and project regulatory strategies by ensuring robust assessment of CMC changes, identification of global regulatory requirements,… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Drug Product Development Date: May 24, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: ... people to make a difference with. **The opportunity** Teva's Global Research & Development (R&D) organization is devoted to...process, and process tech transfer to GMP manufacturing sites. Associate Director is a key leadership role… more
- Bristol Myers Squibb (Summit, NJ)
- …careers.bms.com/working-with-us . **Position Summary** Bristol Myers Squibb is seeking an Associate Director , Principal Product Leader within the Cell Therapy ... and during regulatory inspections + May represent Quality in the Global CMC and Commercialization teams + Supports the Product Specification Committee relating… more
- Lilly (IN)
- …South San Francisco, Stamford, CT, and Madrid, Spain. **Position Summary:** The Associate Director , Clinical Supply Management has responsibility for the end ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... difference with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will be...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …your own career goals. **Job** **Title:** Scientific Associate Director **Location:** New Brunswick **Division:** Global Production & Supply/Pharmaceutical ... at all microbiological testing locations in the BMS network. The Scientific Associate Director will also ensure appropriate strategies for DP-related… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director of Drug Substance - EACD will have the primary responsibility to oversight process development and manufacturing ... manufacturing activities of clinical/commercial stage small molecule APIs. Reporting to the Director of EACD, this individual will provide guidance to the external… more
- Novo Nordisk (Watertown, MA)
- …careers. You'll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of ... Development - Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality Assurance, and Supply… more
