Senior Manager, Cell Therapy Manufacturing, Breyanzi

Celgene • Summit, NJ

72d • Onsite

About The Position

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. 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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. 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.

Requirements

• Extensive knowledge of EHS and cGMPs and the know-how to work and manage within a regulated environment.
• Demonstrates aptitude for biotechnology principles and manufacturing systems.
• Demonstrated proficiency in selection of team and effectively managing personnel issues.
• Adaptable to a fast paced, complex, and ever-changing business environment.
• Excellent communication skills (EN).
• Bachelor's degree in related field is preferred, or equivalent in work experience, and the ability to think and lead strategically.
• 7+ years of relevant manufacturing experience in bulk biologic or cell therapy manufacturing.
• Minimum of 5 years leadership experiences including the management of direct reports required with previous experience in team development.
• 2-3 years working with team on KPI's.
• 2-3 years with regulatory audit direct interactions or SME experience.
• Project Management experience.

Nice To Haves

• Knowledge of lean manufacturing principles required. Green belt certified is a preference.
• Advanced degree preferred.
• Previous experience working on a second shift highly desired.
• Quality experience.

Responsibilities

• 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 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Effectively controls expenses within their influence (OT, Supplies, T&E).
• 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.
• Is responsible to participate in the weekly Deviation, CAPA, and Change Control meetings to provide status updates on the quality records owned by them.
• Attends the daily cross-functional manufacturing meeting providing summary of previous day activities, successes, or communicates equipment outages or processing delays.
• Maintain balanced and unbiased functional relationships, championing a culture of exceptional teamwork and communication across the organization.
• Identifying and where possible mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
• Develop their team through scheduled coaching sessions 56. Instill proper problem identification behaviors.
• Acknowledge ideas and/or issues with feedback on path forward (either yes, we will look into that or no, not now... maybe later)
• Coordinate across the value stream to align with appropriate goals and objectives. Ability to breakdown larger goals to goals that can be influenced within their 4 walls.
• Escalate issues at the appropriate level of urgency.
• Participate, lead, or coach Go & See (Gemba) activities in their areas for current state understanding, process confirmation, waste reduction, increased flow, continuous improvement idea generation, coaching, or employee engagement.
• Lead, coach or participate in Improvement & Coaching Kata at Tier Board Meetings, at the department's work area, or with individual team members to creatively experiment and deliver practical improvements to gaps to target.
• Support their team by removing bottlenecks to problem-solving efforts and/or escalating problems or communicating resolutions through Tiered Management process.
• Communicate expectations for the usage of Improvement/Coaching Kata, Go & See
• Engaged and aligned in communicating and driving performance, issues, accountability and solving problems using the designed tiered management processes.
• Recognize team and individuals for their efforts to continuously improve their processes and gaps to target conditions or to model ideal behaviors.
• Create and continuously improve their Leader Standard Work for daily, weekly, quarterly, yearly critical tasks, run the business & improve the business activities.
• Practice Hansei to reassess, realign, refocus teams to disconnects with desired behaviors (Accountability, Root Cause Problem Solving, Continuous Improvement, Cross Functional Collaboration, Leadership Support)
• Take personal responsibility to work safely and ensure colleagues do the same.
• Be the champion for continuous improvement.
• Be purposefully present in the work area.
• Develop a deep ownership and understanding of one's work area.
• Establish performance measures and targets to drive improvements.
• Participate in reviews of performance, generate improvement ideas, and take action.
• Use visual management so no problem is hidden.
• Build a culture of finding root causes and take action to prevent them from recurring.
• Know the value stream for the product/service you are providing to your customers.
• Use actual results to identify waste, reduce variation and improve productivity.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees