Manager, CAR-T Cell Therapy Manufacturing

About the position

The purpose of the Manufacturing Manager role is to manage and provide oversight of a Work Centered Team (WCT) whose primary responsibility is the execution of Cell Therapy manufacturing processes. The Manufacturing Manager is responsible to ensure their WCT members maintain a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function. This position reports to the Senior Manager, Manufacturing. Shift Available: Wednesday - Saturday (with e/o Wednesday off), Onsite Overnight Shift, 5 p.m. - 5:30 a.m.

Responsibilities

• Leads by example and drives their team to adhere to the BMS values of Inclusion, Integrity, Accountability, Innovation, Urgency, Passion, and GMP.
• Ensures 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.
• Resolves documentation errors and corrections as needed to enforce manufacturing turn-around times.
• Maintains hands-on expert knowledge of each Unit Operation and demonstrates what good execution looks like to new WCT members.
• Provides the Production Scheduling team with information on the availability of their WCT production resources.
• Sets WCT priorities and adjusts as necessary to track site and functional priorities.
• Ensures that their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing.
• Builds high performing WCTs comprising of Operators, Team Leads, and Supervisors.
• Conducts regular 1:1 meetings with each WCT member to mentor, develop and motivate them.
• Works proactively to reduce the number of deviations occurring within the WCTs.
• Participates in CAPAs, Change Controls, and Projects as required by the business.
• Facilitates and leads weekly Tier meetings and Performance Review meetings with their WCT.

Requirements

• Bachelor's degree in related field is preferred, or equivalent in work experience.
• 5+ years of relevant manufacturing experience (pharmaceutical experience preferred).
• Minimum of 2 years of people leadership experience is required.
• Extensive knowledge of EHS and cGMPs and the know-how to work and manage within a regulated environment.
• Ability to aseptically gown (up to ISO 5 level gowning).
• Demonstrates aptitude for biotechnology principles and manufacturing systems.
• Knowledge of lean manufacturing principles required.
• Excellent communication skills.

Nice-to-haves

• Advanced degree preferred.
• Demonstrated proficiency in selection of team and effectively managing personnel issues.
• Adaptable to a fast-paced, complex and ever-changing business environment.

Benefits

• Competitive benefits, services, and programs to support employees' goals.
• Opportunities for growth and development.