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Bristol Myers Squibb Associate Director, Process Microbiology MS&T 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.

The Associate Director of Process Microbiology in Manufacturing Sciences & Technology will serve as a Process Microbiology subject matter expert, technical lead, and people leader supporting development, clinical, late-stage and commercial manufacture of biopharmaceuticals. Responsibilities include leading a team of scientists with accountability to define the global strategy for managing and harmonizing the bioburden control strategy for drug substance and drug product processes across the BMS network. The AD of Process Microbiology develops in-process microbiology control strategies supporting the execution of process technical transfers. The role will establish business processes and technical rationale for the BMS global bioburden control strategy. Additional key responsibilities are network investigation support, authoring of CMC regulatory submissions, and advancing experimental capabilities and future technologies.

Responsibilities:

  • Manages and supervises a team of PhD/MS/BS Scientists by setting appropriate objectives and priorities, driving strategic initiatives, and executing on projects to deliver on-time results.

  • As a process microbiology subject matter expert, provides strong technical leadership to resolve complex problems, support critical investigations, and influence the global manufacturing network for process alignments.

  • Supports process technical transfers across the BMS network, by establishing in-process control strategies for bioburden control.

  • Defines the global strategy for managing and harmonizing the bioburden control strategy supporting biologics operations for DS and DP across the network.

  • Develops novel methodologies to enhance our current understanding of bioburden detection, employs Design of Experiments (DOE) techniques, and identifies experimental approaches to support our global microbial testing methodology.

  • Establish and document business processes and technical rationale for the BMS bioburden control strategy.

  • Interacts with global Health Authorities, during site inspections, contributes to agency responses, and authors process microbiology CMC sections of regulatory submissions.

  • Reviews and approves study designs, project milestones, experimental plans, technical documents and white papers.

  • Develops key talent and establishes succession plans.

  • Understands microbiology analytical tools and techniques, and is comfortable working in both a laboratory and office environment.

  • Influences and promotes the advancement of new technologies and capabilities, and scientific practices.

  • Networks with external scientists in academia and industry to maintain a high level of current knowledge.

Experience:

  • Bachelor’s degree or equivalent in relevant discipline with a minimum of 14 years of relevant experience.

  • Advanced technical degree in a scientific discipline (MS/PhD) is preferred. Time spent in advanced degree programs may be considered as relevant experience.

  • Demonstrates advanced knowledge of microbiology and biologics manufacturing, including experience with cGMP regulations and regulatory requirements, and knowledge of microbiology analytical tools. Recognized as an industry expert.

  • Supervisory experience in leading scientific teams.

  • Demonstrated skills in cross-functional partnerships, leading cross-functional teams.

  • Knowledge of regulatory and cGMP requirements are required.

  • Strong organizational, communication, and technical writing skills are required.

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.

Company: Bristol Myers Squibb

Req Number: R1534651-en-us

Updated: 2021-01-26 00:42:21.137 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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