- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategy & Investigations Owner/ Lead as part of the Technical ... This individual will be responsible for a global operational strategy and investigations lead / owner for a best-in-class high volume marketed CAR-T product as part… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC ... 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 (Rahway, NJ)
- …Operations. We are seeking a highly motivated individual for the role of Associate Director , Tech Transfer Leader in Large Molecule Technology Transfer within ... Technical Product Leadership. This role will lead a team of scientists and engineers with a...Drug Substance and Drug Product for all large molecules. Associate Director is expected to contribute to… more
- Sanofi Group (Bridgewater, NJ)
- …Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Specialist leverages their regulatory expertise to contribute ... business planning, governance, and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Sanofi Group (Bridgewater, NJ)
- …Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist leverages their regulatory expertise to contribute ... business planning, governance, and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… 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
- 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …as staff from quality, clinical compliance, regulatory, formulations, and IOPS ( CMC , external manufacturing, stability). **A typical day might include the ... following:** + Serves as lead drug supply manager of a program and/or individual...and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or handles any/all aspects… more
