Senior Manager, Cell Therapy Manufacturing, Breyanzi

Senior Manager Manufacturing

Working with Us 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. Take your career farther than you thought possible.

The purpose of the Senior Manager Manufacturing role is to manage and provide oversight of a team of Manufacturing Managers and their Work Centered Teams (WCT) operating in shifts over a 24 / 7 schedule whose primary responsibility is the execution of Cell Therapy manufacturing processes, maintaining a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function. This position reports to Associate Director, Manufacturing.

Shift Available :

• Monday - Friday, Onsite Afternoon Shift, 3 p.m. - 11 : 30 p.m.

Responsibilities : 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 Manufacturing Managers and 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).

Responsible to own, review, author, or approve SOP, WI, master batch records.

Safety :

Takes personal responsibility to work safely and to ensure their managers and 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.

Documentation :

Is accountable for the Production Records produced by their Manufacturing Managers and WCT members.

Performs batch record reviews (BRR) or Electronic Batch Record review by exception.

Ensures that all documentation produced by their Managers and WCTs follows the ALCOA+ principles.

Ensures the documentation produced by their Manufacturing Managers and 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.

Process Expertise :

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 managers and WCT members and when necessary, back fills for absent team members or makes up the execution resource requirements to meet the production schedule.

Supports Material Review Board (MRB) data collection and provides process expertise when required to support the MRB decision making process.

Rotates weekend coverage for manufacturing operations and is first line support for any technical or manufacturing issues during weekend coverage.

Continues to develop expertise in the field of CAR T Manufacturing and regulatory requirements that pertain CAR T manufacturing.

Resource Management :

Is responsible to provide the Production Scheduling team with information (daily, weekly monthly) on the availability of their managers and 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 and sustain the manufacturing culture and that meet budgetary and fiscal requirement.

Priorities :

Sets their managers and 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.

Training :

Ensures that their Manufacturing Managers and their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.

Is responsible to maintain their Manufacturing Managers, themselves, and WCTs training compliance at the required 100% on-time completion rate.

Ensures that their Manufacturing Managers and 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 Manufacturing Managers and 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 :

Is responsible to build high performing WCTs comprising of Manufacturing Managers, 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 Manufacturing Manager 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, Warehouse, Supply Chain and Manufacturing Science & Technology, QC Laboratories, QA Doc Control and Training & Learning Organization to sustain and maintain compliant manufacturing processes.

Deviations :

Leads troubleshooting activities for their WCTs and is a Deviation Business Process Owner (BPO) or Business Technical Approver (BTA) for deviation approvals occurring in their area.

Oversees their WCTs to ensure they author clear, concise, and factually complete descriptions of events that led to the deviation and ensures timely entry of the deviation record information in the system.

Maintains deviation metrics and ensures deviation awareness for the WCTs across all shifts, Pareto's out worst or repeat causes of deviations and ensures close out of all deviations on time.

Works proactively with their Manufacturing Managers and WCTs to reduce the number of deviations occurring and to eliminate repeat causes of deviations.

Is accountable to drive continuous improvement to prevent repeat deviations.

Reviews the Manufacturing Managers (No Impact) deviation records and ensures they are a clear and concise representation of the event and that all entries comply with ALCOA+ documentation principles.

Reports out deviation progress, maintains their deviation metrics, Pareto's out worst or repeat causes of deviations and closes out all deviations on time.

Ensures their Manufacturing Managers maintain deviation closure rate (on-time 2 days prior to due date).

Provides reinforcement discussion or coaching as needed to build WCT expertise.

CAPAs, Change Controls & Projects :

Participates in CAPAs, Change Controls and Projects from time to time as required by the business and directed by senior management.

Implements or holds Managers responsible for the implementation of CAPAs prior to due date.

Participates in CAPA, Change Control meetings and defines, agrees, or owns CAPAs, Change Controls for manufacturing.

Budgets :

Effectively controls expenses within their influence (OT, Supplies, T&E).

Meetings :

Is responsible to facilitate and lead weekly Tier meetings with each of the Manufacturing Managers and cross functional partners using the site standard Tier meeting tools.

Is responsible to facilitate and lead weekly Performance Review meetings with each of the Manufacturing Managers and cross functional partners using the site standard Performance review meeting tools and cascading KPIs / Metrics.

Is responsible to participate in the monthly Manufacturing Performance Review meetings (facilitated by the Manufacturing Associate Directors).

Is responsible to participate in the weekly Production Scheduling meeting to provide a summary of their WCTs training status and resource availability / constraints to be able to execute the proposed production plan in the days / week ahead.