Manager, Value Stream CAR-T Manufacturing

Job Title

Manager, Value Stream CAR-T Manufacturing

• Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m.
  
  - 5:30 a.m.

• Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion
• Is accountable to ensure their WCT members execute the manufacturing of Cell Therapy products according to Current Good Manufacturing Practices (cGMP’s) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Takes personal responsibility to work safely and to ensure their WCT members do the same
• Performs regular safety Gemba walks, knows the hazards associated with their work and demonstrates safe behavior
• Operates and maintains equipment to prevent injuries or incidents
• Is accountable for the Production Records produced by their WCT members
• Performs batch record reviews (BRR) or Electronic Batch Record review by exception
• Ensures that all documentation produced by their WCT members follows the ALCOA+ principles
• Ensures the documentation produced by their WCT members is right first time and all records and logbooks are complete and accurate
• Resolve documentation errors and corrections as needed to enforce manufacturing turn‑around‑times
• Is required to perform Cell Therapy manufacturing to maintain hands on expert knowledge of each Unit Operation, demonstrate what good execution looks like to new WCT members and when necessary, back fills for absent team members or makes up the execution resource requirements to meet the production schedule
• Further develops technical expertise of CAR T Manufacturing requirements
• Is responsible to provide the Production Scheduling team with information (daily, weekly monthly) on the availability of their WCT production resources and tracks/maintains records of all team members actual availability vs planned or unplanned absence due to holidays, sickness or other reasons
• Is responsible to hire personnel that meet job description criteria and BMS values that meet budgetary and fiscal requirement
• Sets their WCTs priorities and adjusts as necessary to track the site and or functional priorities, establishes the WCT goals and is responsible to monitor, measure and assess the performance/completion of the WCT manufacturing activities and goals
• Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans
• Ensures that their WCTs have the appropriate level of training necessary for CAR‑T GMP manufacturing in a multi‑product commercial facility
• Accountable to maintain their own and WCTs training compliance at the required 100% on‑time completion rate
• Ensures that their WCT members are proficient and qualified to perform the manufacturing tasks before doing so
• Monitors team training due dates and maintains the trained status of their WCT members by ensuring appropriate time is allocated to training activities
• Immediately disqualifies personnel from GMP tasks if observed to not comply with SOPs, Wis, or batch records, including safety trainings
• Is responsible to build high performing WCTs comprising of Operators, Team Leads and Supervisors
• Recruits exceptional people, conducts interviews, reviews candidates’ suitability and provides meaningful feedback to Talent Acquisition and HR partners during the recruitment process
• Is responsible to create and maintain Workday profiles for all new hired staff
• Is responsible to administer the annual performance review process, differentiating performance between team members
• Gives recognition when deserved and guidance to improve poor performance or behavior not aligned with the BMS values
• Conducts regular 1:1 meeting with each WCT member to mentor, develop and motivate them
• Cascades relevant company information and takes time to help team members with their professional development including seeking out potential career development opportunities
• Creates a culture of learning via discussion of deviations, safety incidents, and provides meaningful, timely, and accurate coaching during processing
• Develops cross‑functional relationships with Quality Shop Floor,…