- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… more
- Bristol Myers Squibb (Summit, NJ)
- …a member of a cross functional team responsible for drug product related CMC strategy development. **Key Responsibilities** The Senior Principal Scientist will ... and support the generation of appropriate responses to questions from regulatory authorities. **Key Responsibilities** The Senior Principal Scientist will… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** ** Senior Manager , Formulation Development** will be responsible for leading drug ... the Manufacturing and Supply Chain group of the ITCI CMC team. Responsibilities: + Lead and support activities for...veteran status, disability or any other legally protected status. Senior Manager , Formulation Development: Base Salary Range… more
- System One (Summit, NJ)
- Job Title: Senior Project Manager Location: Summit, NJ Hours/Schedule: M-F (normal working hours) Type: Contract Overview Leading pharmaceutical company looking ... for an experienced Project Manager . Ideal candidates should have 5+ years of experience...Therapy or Biologics + Understanding of GMP and FDA regulatory requirements correlating to biologics + Bachelors/Masters degree in… more
- Merck (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... supplies. + Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). **A ... The **Sr Manager , Clinical Drug Supply & Logistics** is responsible...within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs /… more