Manager, Manufacturing
Bristol Myers Squibb
This listing was originally posted on Bristol Myers Squibb's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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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.
Position Summary
The Manufacturing Manager I leads and drives the execution of manufacturing processes according to established electronic work instructions and production records for the manufacture of cell therapies with Current Good Manufacturing Practices (cGMP’s). The Manager I is responsible for leading a team whose primary focus is on execution of manufacturing processes, technical assessment of processes, and driving a culture of safety, compliance, and innovation within their functional group. The Manager I plays a crucial role in guiding personnel in their group with technical expertise to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements. This role also creates an environment that fosters idea generation, team and cross-functional collaboration, and execution of success, repeatability, and reliability of process and staff.
Duties/Responsibilities
Manages the creation, implementation and compliance of all Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms) related to cell therapy operations for self and others
Oversee operations within the requirements of a validated manufacturing system(s)
Plan, assign resources and oversee daily operational activities associated with assigned areas of responsibility while controlling costs
Maintain operating and storage areas to ensure that they are compliant, efficient, effective, safe and always inspection ready
Drives right-first-time initiatives and holds team accountable for compliance performance. Generates solutions for compliance issues.
Prepares, gains alignment and implements Change Controls
Completes MRB slides and presents at MRB meetings as needed
Initiates change controls, notice of events, deviations and investigations and drives actions to closure as assigned
Evaluates team performance and drives continuous improvement of cost, quality, safety, culture and delivery.
Identify strategic and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation responses and investigations
Verify manufacturing associates and team leads are fully trained on respective curricula to maintain compliance prior to performance any GxP task.
Create an environment of teamwork, open communication, and a sense of urgency. Foster a culture of safety and compliance that embraces safety in the work environment, including psychological safety, and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner and in accordance with schedules and defined implementation timelines
Presence in the cell therapy manufacturing facility to participate in walk throughs, provide process troubleshooting, participate in event triages, and have direct contact with manufacturing personnel in order to provide timely, effective coaching.
Oversee operators on daily basis as they:
Perform unit and support operations described in Source Governing Documents in a safe and GMP compliant manner
Complete documentation contemporaneously required by Source Governing Documents.
Maintain training compliance by completing all training assignments to ensure the necessary technical skills and knowledge
Assist in the setup of manufacturing areas and equipment/fixtures, facility and equipment commissioning, and qualification and validation activities
Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
Hire, mentor and develop exceptional people. Conduct effective performance reviews with supporting documentation and identify opportunities for career growth for manufacturing associates. Immediately address performance issues through document coaching / feedback as required.
Reporting Relationship
Sr. Manager or Associate Director
Qualifications
Education
Bachelors in relevant science or engineering discipline, or equivalent in work experience
Experience
5+ years of experience in cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience with 2 years leadership experience (i.e. lead or equivalent) including performance management responsibilities is highly desirable
Experience in the following is highly preferred:
Cell therapy manufacturing
Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2/ML-1 containment areas.
Cell expansion using incubators and single use bioreactors, Cell washing processes, Cell separation techniques and cryopreservation processes and equipment.
Working Conditions:
Must be able to stand/walk for extended periods of time.
Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as needed), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection.
Required to carry and/or lift up to 30 pounds, 15 kg, several times a day, while handling production equipment and/or materials.
Required to push and/or pull up to 50 pounds, 25 kg, several times a day, while handling production equipment and/or materials.
Work is areas that may have strong magnets.
Must be able to work in a BSL2 / ML-1 work environment handling human blood components
Work in areas with exposure to vapor phase liquid nitrogen
Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays)
SHIFT OPTIONS
Days – Sun – Tue (alt. Wed) 0500 – 1730
Days – Thu – Sat (alt. Wed) 0500 – 1730
Swing – Sun – Tue (alt. Wed) 1100 – 2330
Swing – Thu – Sat (alt. Wed) 1100 - 2330
Nights – Sun – Wed (alt. Sat) 1700 – 0530
Nights – Wed – Fri (alt. Sat) 1700 – 0530
BMSCART
#LI-ONSITE
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:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
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