Senior Manager, CTO MSAT Process Validation

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 rich in diversity. 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 Title:

Senior Manager, Manufacturing Science and Technology (MSAT) Process Validation

Location:

Cell Therapy Operations (CTO) Summit West, NJ, S12

PURPOSE AND SCOPE OF POSITION:

The Senior Manager for MSAT Process Validation is responsible for supporting the production of personalized cell therapy products for global clinical trials and commercial supply in the CTO Summit, NJ manufacturing site.  The Senior Manager develops, supports and leads qualification and validation activities (e.g. protocols, reports, site procedures and batch records, and agency filing content) satisfying internal and external regulatory expectations. The Senior Manager will collaborate with Global MSAT as well as Product and Development, Manufacturing Operations (MO), Supply Chain (SC), Quality Control (QC) and Quality Assurance (QA) departments while providing technical support for the resolution of validation related project deliverables, evaluation and implementation of process changes and continuous process improvement support to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. 

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

• Expert knowledge of good manufacturing practices (GMP) and quality systems concepts.
• Familiarity with 21 CFR Part 11, cell therapy/ biopharmaceutical industry guidelines and/or health authority (HA) regulations and associated compliance documentation (e.g. FDA, EMA, Health Canada, IGJ, etc).
• Expert knowledge of manufacturing facility and clean room designs, cell therapy processes and technologies, equipment, automation, and validation activities.
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities and cell therapy products.
• Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas of process validation principles and design.
• Experience with Change Controls, CAPAs, Deviations, standard operating procedures (SOPs), protocols and reports.
• Effectively communicates with internal and external cross-functional teams and represents department in collaborations to drive successful completion of projects within defined timelines across the cell therapy division and network.
• Must have strong authorship skills and be able to critically review protocols, investigations, deviations, reports, interpret results, and generate technical conclusions consistent with fundamental scientific knowledge, GMP and Good Documentation Practices (GDocP).
• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.
• Ability to work independently with minimal direction to completes tasks, ability to obtain resources and information from established internal contacts; consults with supervisor for decisions outside established processes; authority to make daily decisions in support of team goals.
• Ability to prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Experience with Operational Excellence and Lean Manufacturing.
• Possesses strong leadership skills in a multi-project industry setting and be able to act as validation team lead in the absence of the Associate Director.

Education and Experience:

• Bachelor’s Degree required (science or engineering is preferred), Advanced Degree is a plus
• Minimum of 8 years of manufacturing support or related experience in the biopharmaceutical industry
• Minimum 4 years of leadership experience including management of direct reports
• Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

• Support CAR-T manufacturing site Process Validation activities including, but not limited to, Aseptic Process Simulations/ Validations (APS/APV), Process Performance Qualifications (PPQ), Dynamic Airflow Visualization Studies, Container Closure Integrity Testing (CCIT), Continued Process Verification (CPV) programs and revalidation strategies to meet GMP deadlines, to ensure that the programs are compliant with regulatory agencies requirements.
• Execute all responsibilities to meet cGMP and 21 CFR Part11 data integrity requirements and ensure validation activities are maintained in a state of control and compliance.
• Leads development of process validation strategies, protocols, SOPs, and batch records for Cell Therapy manufacturing processes as well as data analysis and compilation of results.
• Ensure the site process validation program, standards, master plans, process qualification strategies/protocols, associate reports and procedures, and CPV strategies are implemented consistently and support execution and closure of validation activities.
• Collaborate with internal and external cross-functional teams for validation executions, tech transfers, and new product launches to ensure that knowledge is transferred, control strategies are appropriate, and risks are analyzed to ensure that commercial processes are validation ready.
• Support process validation lifecycle activities by ensuring a state of control is maintained through CPV programs.
• Management and scheduling of validation team activities and provide guidance/coaching to direct reports.
• Must provide guidance and provide clear direction to other MSAT Validation team members in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities.
• Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations and support career development of direct reports
• Coordinate and collaborate with other departments (e.g., Process Engineering (PE), Facilities, Manufacturing Operations (MO), Quality Control (QC), Quality Assurance (QA), Supply Chain (SC) and Regulatory) to ensure achievement of objectives relating to process validation executions and associated activities, including compliance with all applicable standards.
• Leads APS/APV, PPQ and validation projects by providing technical oversight, coordinate preparation, training execution and oversight, and report closures throughout the product life cycle.
• Author, review and approve process validation protocols and reports, data retrieval, compilation, and verification from a variety of 21CFR Part 11 compliant electronic systems.
• Provide technical input, lead validation related deviations and investigations, perform root cause analysis and implement CAPAs, ensuring compliance with validated state of the manufacturing process.
• Support and assess site validation impacts to change initiatives and the implementation of process improvement initiatives via CAPAs and Change Controls to identify requirements necessary to maintain validated status.
• Author and support validation risk assessments for existing and new/changed processes.
• Must be able to work in controlled environments requiring clean room gowning in ISO 5/Grade A, ISO 7, Grade B, and ISO 8/Grade C and D areas.
• Serve as the validation, data integrity, and CPV Subject Matter Expert (SME) within the team.
• Support the tracking of team metrics and manage completion of objectives and projects.
• Actively support and lead process validation deliverables for Health Authority (HA) regulatory submissions and inspections, maintaining permanent inspection readiness for process validation.
• Support stakeholders in accomplishing productivity goals with internal and external cross-functional teams.
• Support the Associate Director in the development and implementation of programs for the CTO network that ensure all aspects of the validation programs are maintained in a state of compliance with respect to corporate and regulatory standards.
• Stay current with industry trends, guidelines and standards.

Leadership Attributes:

• Create an environment of teamwork, open communication, and a sense of urgency
• Support the change agent in promoting flexibility, creativity, and accountability
• Support organizational strategic goals and objectives that are linked to the overall company strategy
• Build trust and effective relationships with peers and stakeholders
• Deliver business results through timely and quality decision making and advice
• Foster a culture of compliance and strong environmental, health, and safety performance
• Promote a mindset of continuous improvement, problem solving, and prevention

WORKING CONDITIONS (US Only):

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

• Work is performed 25% of the time in a manufacturing and/or laboratory setting, requiring clean room gowning in ISO 5/Grade A, ISO 7, Grade B, and ISO 8/Grade C and D areas.
• Flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.

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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.

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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