- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies ... based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… 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 ... The Principal PQL will support the Global Product Quality Lead (PQL) by providing supportive quality oversight of the...+ May act as author or Quality reviewer of CMC sections of regulatory submissions and response to global… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director , Business Development will seek out potential business opportunities ... efficiently communicating with excellent facilitation. The incumbent will also lead initial partnership, licensing and/or acquisition negotiations with sufficient… more
- Merck (Rahway, NJ)
- …sight to process validation and commercial launch. This role reports into the Associate Vice President, Sterile Products Development. This role is located in Rahway, ... of sight to commercial production + Oversee and review CMC authoring activities for DP manufacturing + Ensure successful...process analysis and control throughout the lifecycle + Attract, lead , and develop a world-class team of scientists and… more
- AbbVie (Madison, NJ)
- …with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or Director , in the ... timely response to Health Authorities during application review. . Support CMC sections of major, complex regulatory submissions, including Investigation New Drugs… more
