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Sr. Manager, CAR T Process & Technology

Company: Bristol Myers Squibb
Location: Summit
Posted on: June 25, 2022

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.PURPOSE AND SCOPE OF POSITION:The Sr. Manager, Process & Technology is responsible for managing activities and personnel associated with design, development, delivery, validation, change management, maintenance and support of site manufacturing execution system (MES), Enterprise Resource Planning (ERP) system, and associated boundary systems across multiple clinical and commercial cell therapy manufacturing sites. The position has direct reports and contractors with indirect management of projects in a cross functional and collaborative environment. The position requires strong project management skills and coordination with stakeholders.
The Process & Technology department supports both the Summit S12 and Warren sites for cellular therapy manufacturing at Bristol-Myers Squibb.DUTIES AND RESPONSIBILITIES:

  • Provide leadership for site Process and Technology Department.
  • Lead the Summit S12 and Warren ERP platform to ensure compliance with site, global and industry standards.
  • Lead the Summit S12 MES platform to ensure compliance with site, global and industry standards.
  • Promotes and enforces standard systems, policies, and procedures for the Oracle platform across both sites.
  • Promotes an environment of continuous quality and improvement of processes, standards, and procedures.
  • Provides coaching, counseling, mentoring, and disciplining to maximize staff effectiveness and cohesion.
  • Major responsibilities include maintaining and implementing the site and global policies for Process and Technology, aligning with Celgene Corporate processes and delivering and maintaining validated technologies suitable for commercial pharmaceutical manufacturing.
  • Works closely with business owners to establish and maintain service level expectations across all functions and site systems.
  • Understands emerging technology and proposes new system solutions/upgrades to improve existing technologies and evaluate potential business and compliance risk.
  • Continuously integrates with the business to understand current business processes and to provide technology guidance that enables and supports future plans and strategies.
  • Coordinates with Global Supply Chain Strategy, Global IT and other manufacturing sites on standardization of system lifecycle management in terms of implementation, support, validation, change management, and system data requirements from a local and global perspective.
  • Utilizes a high-level of understanding of pharmaceutical manufacturing processes, procedures, controls, and cGxP requirements.
  • Utilizes a good overall understanding of process automation, information management systems, SDLC, vendor quality management, infrastructure management, maintenance, and metrology used in manufacturing and laboratory environments.
  • Leads the effort to create and maintain local and global systems and data management strategies related to the cGxP environment and to ensure that those strategies consistently support company initiatives.
  • This position supports business and compliance objectives by ensuring projects and systems and technology service activities deliver high levels of quality, service and cost effectiveness. Performs other tasks as assigned.REQUIRED COMPETENCIES:
    • Ability to think strategically and work independently
    • Advanced teamwork and facilitation skills
    • Ability to develop, delegate, and motivate others
    • Advanced knowledge of MS Office Applications
    • Advanced knowledge of cGMP, GXP regulations, and industry best practices
    • Advanced written and verbal communication skills
    • Advanced organizational and time management skills
    • Advanced critical reasoning and decision-making skills
    • Advanced ability to interpret / draft general business documents
    • Advanced ability to interpret / draft complex technical documents
    • Advanced listening skills
    • Advanced qualitative training skills
    • Intermediate presentation development and delivery skills
    • Requires flexibility and ability to multi-task
    • Requires ability to solve complex problemsEducation and Experience:
      • Bachelor's degree required. Advanced degree preferred.
      • 10+ years of relevant work experience required, preferably in the pharmaceutical or related industry.
      • 4+ years of leadership experience preferred.
      • An equivalent combination of education, experience and training may substitute.
      • Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique is desirable.WORKING CONDITIONS (US Only):
        • The incumbent will be required to work in an office environment potentially requiring ergonomic considerations
        • The incumbent will be required to work in a conference room environment for moderate periods of time.
        • Occasional excursions to labs, production area or warehouse requiring some level of gowning.
        • Occasional domestic and international travel.
        • Exposure to typical manufacturing, laboratory, mechanical and warehouse environments.
        • Flexible to work across both Summit and Warren NJ sites.
        • Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
        • Flexibility to don clean room garments and personal protective equipment (PPE),
        • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
        • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
        • Routine exposure to human blood components and Must be able to work in an environment with blood derived components.
        • Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
          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.
          Why You Should Apply:Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.Our company is committed to ensuring that people with disabilities can excel 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 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.BMSCARTAround the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.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.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Bristol Myers Squibb, New York , Sr. Manager, CAR T Process & Technology, Executive , Summit, New York

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