Description:
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Job Function
- Management of analytical tech transfer activities across API & Drug Product in an external manufacturing environment
- Provision of analytical expertise and troubleshooting support in the areas of API’s and intermediates, drug products, raw materials, and Pharmacopoeia requirements in an external manufacturing environment
- Proactively manage all API & Drug Product Contract Laboratory Service (CLS) providers to Global External Manufacturing from a quality and compliance oversight perspective.
Responsibilities
- Engage with internal and external stakeholders to plan and manage the program for analytical method transfers from BMS to CMOs or CMO to CMO.
- Represent Global External Manufacturing as the QC laboratory subject matter expert in support of due diligence audits and for cause audits where laboratory related issues are a focus for such audits
- Review and approve all major laboratory investigations/OOS events at CMOs & CLS providers.
- Provide technical support to the QP and Quality Operations Managers in relation to same.
- Review and approve analytical change control documents associated with CMOs & CLS providers
- Facilitate and manage the communication flow to and from CMO analytical functions and global functions across BMS such as Global Testing Standards, HQ
- Reference Standards Management Team, Global Analytical Services, Global Regulatory Sciences etc.
- Review and approve analytical method validation documentation & activities at CMOs and CLS providers to determine compliance with ICH requirements and manage remediation of gap analysis at BMS or CLS
- Provide analytical expert support for regulatory submissions
- Prepare, approve and maintain the Quality Agreement with each CLS provider.
- Establish and monitor an effective metrics program to measure the performance of the CLS providers.
- Provide training to wider External Manufacturing team