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Bristol Myers Squibb Senior Manager, Single-Use System in Devens, Massachusetts

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.

Description:

The Senior Manager, Single-Use Systems in the Manufacturing Sciences and Technology Global Capabilities Materials Science group will support the development of single-use system material control strategies for the end-to-end management of biopharmaceuticals manufacturing. The manager will lead scientists in single-use system validation strategies (extractable/leachable, chemical compatibility, container closure and bacterial retention) and life-cycle management. This includes the establishment of risk-based material release specifications for single-use materials.

The position involves technical diligence activities in support of manufacturing operations such as: material characterization and selection in relation to process use, technical material risk assessments, alternate supplier qualifications, and supplier change management.

The successful candidate will collaborate closely within the Manufacturing Sciences and Technology organization as well as with representatives from Global Procurement, Supply Chain, Manufacturing, Manufacturing Technology, Quality Assurance, Quality Compliance, and Global Regulatory Sciences on cross-functional teams to resolve complex problems while meeting quality, cadence, and cost objectives.

Responsibilities:

  • Provides technical leadership for single-use system selection, evaluation, validation, and implementation for use within drug substance and drug product manufacturing

  • Provides technical expertise and authorship for: manufacturing investigations, new material implementations, second sourcing activities, material change controls, and technical material risk assessments.

  • Leads cross functional teams (i.e. Supply Chain, Quality Assurance, Manufacturing, Global Procurement) within strategic initiatives to achieve business continuity objectives.

  • Authors and/or reviews network philosophy papers, SOP, and Work Instructions to support single-use system control strategies

  • Collaborates with internal and external partners to achieve shared goals

  • Provides material subject matter expertise for health authority inspections and interactions with regulatory agencies.

  • Develops CMC strategies and responsible for author/review of regulatory support documentation

Requirements:

  • B.S. with a minimum of 10 years relevant industry experience or equivalent

  • In-depth understanding of industrial single-use technology applications and compliance requirements

  • General understanding of biologic unit operations within drug substance and drug product production

  • Awareness of cGMP compliance and regulatory agency requirements

  • Proven project management skills, including ability to lead multi-functional projects and work prioritization

  • Experience in CMC authoring

  • Demonstrated problem solving ability and scientific leadership

  • Strong work ethic and ability to mentor junior staff

  • Strong oral communication and technical writing skills are essential

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.

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.

Company: Bristol Myers Squibb

Req Number: R1552358

Updated: 2022-01-21 02:46:22.007 UTC

Location: Devens,Massachusetts

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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