Associate Director, CAR-T Process Engineering, Systems and Technology Support

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profile Job Location:

Devens, MA - USA

profile Monthly Salary: Not Disclosed
Posted on: 14 hours ago
Vacancies: 1 Vacancy

Job Summary

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: 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 theres no better place than here at BMS with our Cell Therapy team.

The Associate Director CAR-T Process Engineering Systems & Technology Support leads a team of scientists and process and/or systems engineers that support clinical and commercial cell therapy manufacturing. This team is responsible for product and process monitoring troubleshooting and improving clinical and commercial cell therapy unit operations and process systems records. This position reports to the Director of Process Engineering within the site Manufacturing Sciences and Technology organization.

Shifts Available:

Monday - Friday 8am - 5pm (additional availability for escalations as needed)

Responsibilities:

  • Leads a team of process subject matter experts that support clinical and commercial cell therapy manufacturing operations.
  • Provides on call 24/7 manufacturing support for clinical and commercial production for run the business and continuous improvements or roll out of required system and process updates in alignment with the network
  • Establishes and maintains the sites process monitoring program. Collaborates with other sites and global teams on the continued process verification program and brand APQR.
  • Identify prioritize and drive continuous improvements that reduce safety risks operational costs lead times scrap and discrepancy rates across all aspects of production. Promote problem identification and the creation of meaningful solutions through a culture of proactive problem prevention
  • Reviews and approves manufacturing batch records and procedures
  • Reviews and approves process investigations and change controls
  • Engage and align CMC lifecycle strategy and execution with stakeholders
  • Influence and review technical content within the CMC sections of regulatory filings
  • Build and cultivate for the team and site a culture of maintaining a constant state of inspectional readiness
  • Function as a primary contact for internal and Health Authority audits and driving audit observation corrective actions to closure
  • Serve as MS&T representative on cross-functional and multi-site teams
  • Build and maintain effective collaborative relationships across the site and network influencing site and network product/process life cycle programs
  • Be an active and visible change agent promoting flexible and open mindsets to new opportunities. Exercise sound judgment and flexibility while adapting to rapidly changing priorities challenging situations and deadlines needed to meet business objectives
  • Coach and mentor team members thereby enabling their development and career growth
  • Establish and track departmental performance metrics

Knowledge Skills Abilities:

  • 12 years relevant experience in cGMP environment for Biologics/CMC/Vaccines
  • 4 years managing direct reports with varying levels of experience
  • Ability to prioritize and provide clear direction to team members in a highly dynamic environment
  • Proficient in cGMPs and multi-national biopharmaceutical/cell therapy regulations
  • Experience with internal and health authority audits
  • Excellent verbal/written communication skills and ability to influence at all levels
  • Ability to think strategically and to translate strategy into actions

Minimum Requirements:

  • BS in Engineering or Biotechnology related field. Advanced degree is a plus.

Preferred Qualifications:

  • Subject Matter Expert in cell therapy and/or sterile manufacturing processes with demonstrated ability to troubleshoot issues and provide technical support.
  • Experience with Operational Excellence and Lean Manufacturing is highly desired with experience leading process technology transfer and validation is a plus.
  • This position may require flexibility to travel up to 10 % of time

BMSCART

#LI-ONSITE

If you come across a role that intrigues you but doesnt 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:

Devens - MA - US: $185580 - $224880

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 employees 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 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 . Visit 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: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at 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 . 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.

R: Associate Director CAR-T Process Engineering Systems and Technology Support

Required Experience:

Director

Working with UsChallenging. Meaningful. Life-changing. Those arent 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 breakthrou...
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Key Skills

  • Go
  • Lean
  • Management Experience
  • React
  • Node.js
  • Operations Management
  • Project Management
  • Research & Development
  • Software Development
  • Team Management
  • GraphQL
  • Leadership Experience

About Company

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Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more

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