Team Lead, Devens QC Release and Stability Sample Management

Qlty Assurance Methods

icon-location-marker Devens - MA - US
Posted 48 days ago Full_time R1519113

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Devens Sample Management Team fulfills responsibilities within four main categories:

1. Critical Reagent and Reference Standard Management

  • Ordering
  • Receipt
  • Inventory

2. Stability Sample Management

  • Receipt and aliquotting
  • Inventory management
  • Logistics
  • Disposal

3. Pre-harvest and release sample management

  • Receipt and aliquotting
  • Logistics (sample prep, ship-outs)
  • Data transcription and authorization
  • Disposal

4. Raw Material and Drug Substance Retain Sample Management

  • Receipt, inventory, inspection, disposal

Our work in these four areas serves stakeholders in Commercial and Clinical Manufacturing, BMS Stability Organizations, and BMS Quality Control Organizations.

The Team Lead is responsible for the following core job functions (in collaboration with Supervisor):

  • Scheduling tasks within and outside of the lab in accordance with priority
  • Training new and existing staff
  • Attending routine meetings (i.e. updates with Contract Test Labs and Site-based Lot Disposition Check-ins)
  • Data transcription and authorization in electronic system
  • Development and revision of new and existing SOPs
  • Review of executed work in paper-based and electronic formats and ensuring timely review and archival of documentation
  • Troubleshoot and assist teammates and colleagues when there are questions or challenges and escalate to Supervisor as needed
  • Ensuring that Team’s Key Performance Indicators (KPIs) are routinely tracked and reported to Supervisor and help identify and develop new metrics as appropriate
  • Assistance with monitoring and management of Controlled Temperature Units (CTUs)

The Team Lead will have opportunity to assist and/or lead in the following areas when applicable:

  • Investigation Leadership
  • Internal and Regulatory Agency Audit prep and support
  • Team-based, departmental, and site projects
  • Operational Excellence initiatives

    Electronic systems used:

  • Maximo – Asset Management
  • DCA – document management system
  • Laboratory Execution System – electronic lab notebook
  • Sample Manager LIMS – Lab information management system
  • DeltaV – alarm monitoring system
  • Trackwise / Infinity – Quality Management System

Preferred attributes/skillsets:

  • Experience in Pharmaceutical GxP environment and familiarity with GDP compliance
  • Ability to learn quickly and manage shifting priorities
  • Experience working in a matrix environment
  • Continuous Improvement mindset / Operational Excellence
  • Proficiency in written and verbal communication
  • Familiarity with audit protocol
  • Works well independently as well as in a team environment
  • Critical thinking / troubleshooting
  • Organizational skills and proficiency in Microsoft Office and other electronic systems

Qualifications:

  • Bachelor's Degree with experience in a combination of some of the following: Biology, Logistics, Inventory Management, Operations management, Cell Culture, Quality control
  • Minimum 4 years experience in Pharmaceutical or related field. 
  • demonstrated effectiveness as a lead is a plus

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 the resources to pursue their goals, both at work and in their personal lives.