Bristol Myers Squibb
Manufacturing Manager, Liso-cel CAR-T, Manufacturing Operations
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Manufacturing Manager, Liso-cel CAR-T, Manufacturing Operations
Role overview and responsibilities are described in the original posting. This description covers leadership of a Work Centered Team (WCT) responsible for the execution of Cell Therapy manufacturing processes, ensuring safety, compliance, innovation, and Continuous Improvement within Manufacturing Operations.
Shift
Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m.
Values
Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion
GMP
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).
Safety
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 turnaround-times.
Maintains hands-on expert knowledge of CAR T Unit Operations and backs up for absent team members as needed.
Further develops technical expertise of CAR T Manufacturing requirements.
Priorities
Sets their WCTs priorities and adjusts as necessary to track the site and functional priorities; establishes WCT goals and monitors performance.
Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plan.
Training
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.
Team Building and Development
Builds high performing WCTs comprising Operators, Team Leads and Supervisors.
Recruits exceptional people, conducts interviews, reviews candidates' suitability, and provides meaningful feedback to Talent Acquisition and HR partners during recruitment.
Creates and maintains Workday profiles for all new hired staff.
Administers the annual performance review process and differentiates performance between team members.
Gives recognition when deserved and provides guidance to improve poor performance.
Conducts regular 1:1 meetings with each WCT member to mentor, develop and motivate them.
Cascades company information and supports professional development for team members.
Creates a culture of learning through discussion of deviations, safety incidents, and coaching during processing.
Develops cross-functional relationships to sustain compliant manufacturing processes.
Deviations
Works proactively to reduce deviations and drives continuous improvement to prevent repeats.
Prepares No Impact deviation records and ensures they comply with ALCOA+ documentation principles.
Provides Area Management Approval for deviations within their WCT as needed.
Reports deviation progress, maintains deviation metrics, and closes deviations on time.
Provides coaching to build WCT expertise.
CAPAs, Change Controls & Projects
Participates in CAPAs, Change Controls and Projects as required by the business and directed by senior management.
Behaviors
Maintain balanced and unbiased functional relationships; promote teamwork and communication.
Identify and mitigate risks in manufacturing operations that could affect delivery of therapies to patients.
Develop their team through coaching and feedback.
Lead Go & See activities and Improvement & Coaching Kata at Tier Board Meetings and across teams.
Remove bottlenecks to problem-solving and escalate issues as needed.
Establish Leader Standard Work and visual management to drive improvements.
Practice Hansei to realign teams with desired behaviors.
Take ownership of work area and drive performance, accountability, and problem-solving across the value stream.
Basic Requirements
Bachelor's degree in related field preferred, or equivalent work experience; ability to think and lead strategically.
5+ years of manufacturing experience within a GMP facility.
Minimum of 2 years leadership experience including management of direct reports.
Preferred Requirements
Advanced degree preferred.
Working Condition
Intermittent walking and sitting; may need to sit or stand for extended periods.
Must be comfortable working with contained human blood components.
Physical dexterity to use computers and documentation; good vision and hearing.
Ability to lift 25 pounds; work around laboratories and cleanroom areas with PPE.
Cleanroom garments required; no makeup, gum, or nail polish in restricted areas.
Flexibility to don PPE; clean room environment with restricted spaces and controlled conditions.
Routine exposure to human blood components and possible magnets; some sites prohibit food and outside materials.
Other duties as assigned; this description summarizes the general nature of work.
BMSCART,
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview Summit West - NJ - US: $103,560 - $125,495. The starting compensation range for this role is listed above for a full-time employee. Additional incentive cash and stock opportunities may be available. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Uniquely Interesting Work, Life-changing Careers: With Transforming patients' lives through science as our vision, each employee plays an integral role in work that goes beyond ordinary.
On-site Protocol discusses occupancy types and accessibility; see the full Equal Employment Opportunity statement and accommodations information in the original posting.
Compliance with safety and vaccination guidance remains part of our policy.
Location references and additional job postings for related roles are included in the original posting.
#J-18808-Ljbffr
Shift
Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m.
Values
Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion
GMP
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).
Safety
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 turnaround-times.
Maintains hands-on expert knowledge of CAR T Unit Operations and backs up for absent team members as needed.
Further develops technical expertise of CAR T Manufacturing requirements.
Priorities
Sets their WCTs priorities and adjusts as necessary to track the site and functional priorities; establishes WCT goals and monitors performance.
Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plan.
Training
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.
Team Building and Development
Builds high performing WCTs comprising Operators, Team Leads and Supervisors.
Recruits exceptional people, conducts interviews, reviews candidates' suitability, and provides meaningful feedback to Talent Acquisition and HR partners during recruitment.
Creates and maintains Workday profiles for all new hired staff.
Administers the annual performance review process and differentiates performance between team members.
Gives recognition when deserved and provides guidance to improve poor performance.
Conducts regular 1:1 meetings with each WCT member to mentor, develop and motivate them.
Cascades company information and supports professional development for team members.
Creates a culture of learning through discussion of deviations, safety incidents, and coaching during processing.
Develops cross-functional relationships to sustain compliant manufacturing processes.
Deviations
Works proactively to reduce deviations and drives continuous improvement to prevent repeats.
Prepares No Impact deviation records and ensures they comply with ALCOA+ documentation principles.
Provides Area Management Approval for deviations within their WCT as needed.
Reports deviation progress, maintains deviation metrics, and closes deviations on time.
Provides coaching to build WCT expertise.
CAPAs, Change Controls & Projects
Participates in CAPAs, Change Controls and Projects as required by the business and directed by senior management.
Behaviors
Maintain balanced and unbiased functional relationships; promote teamwork and communication.
Identify and mitigate risks in manufacturing operations that could affect delivery of therapies to patients.
Develop their team through coaching and feedback.
Lead Go & See activities and Improvement & Coaching Kata at Tier Board Meetings and across teams.
Remove bottlenecks to problem-solving and escalate issues as needed.
Establish Leader Standard Work and visual management to drive improvements.
Practice Hansei to realign teams with desired behaviors.
Take ownership of work area and drive performance, accountability, and problem-solving across the value stream.
Basic Requirements
Bachelor's degree in related field preferred, or equivalent work experience; ability to think and lead strategically.
5+ years of manufacturing experience within a GMP facility.
Minimum of 2 years leadership experience including management of direct reports.
Preferred Requirements
Advanced degree preferred.
Working Condition
Intermittent walking and sitting; may need to sit or stand for extended periods.
Must be comfortable working with contained human blood components.
Physical dexterity to use computers and documentation; good vision and hearing.
Ability to lift 25 pounds; work around laboratories and cleanroom areas with PPE.
Cleanroom garments required; no makeup, gum, or nail polish in restricted areas.
Flexibility to don PPE; clean room environment with restricted spaces and controlled conditions.
Routine exposure to human blood components and possible magnets; some sites prohibit food and outside materials.
Other duties as assigned; this description summarizes the general nature of work.
BMSCART,
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview Summit West - NJ - US: $103,560 - $125,495. The starting compensation range for this role is listed above for a full-time employee. Additional incentive cash and stock opportunities may be available. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Uniquely Interesting Work, Life-changing Careers: With Transforming patients' lives through science as our vision, each employee plays an integral role in work that goes beyond ordinary.
On-site Protocol discusses occupancy types and accessibility; see the full Equal Employment Opportunity statement and accommodations information in the original posting.
Compliance with safety and vaccination guidance remains part of our policy.
Location references and additional job postings for related roles are included in the original posting.
#J-18808-Ljbffr