Bioengineer II

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Meyer Squibb, a company, is developing clinical-stage, novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

We are recruiting a Bioengineer II for Cellular Analytics in Cell Therapy Analytical Development organization. S/he will work with a talented and experienced team to enable the rapid advancement of cellular therapy candidates from pre-clinical development through commercialization. In addition to proven leadership capabilities, the successful candidate should have experience in the development and implementation of analytical methods for cell analysis, including flow cytometry, as well as assessment and implementation of new technologies. The incumbent will provide strategic direction for the department to establish platform cell analysis strategies, analytical method lifecycle management, and development and implementation of novel technologies. This candidate will report into the lead of Cellular Analytics group which is part of Analytical Development Department.

Responsibilities will include, but are not limited to, the following:

Provide scientific and technical guidance to analytical development programs in support of the development, characterization, qualification, GMP implementation and scale-up of cell analytics methods.

Responsible for carrying out laboratory experiments and analysis for cancer immunotherapy drug product.

Conduct experiments/analysis independently and draw conclusions from data, results with minimal guidance.

Communicate effectively within and across groups. Perform instrument/method troubleshooting within analytical method parameter.

Oversee the design, development, and qualification of analytical methods to assess cellular product identity, purity, quality and potency. Collaborate with other Analytical Development (AD) departments/scientists to ensure the overall analytical strategy is complete and phase appropriate as a member of the AD team.

Coordinate, lead and participate in various aspects of method development, transfer, characterization, investigation and assay validation while collaborating with Cell Therapy Technology, QC, Process Development, Clinical and Commercial Manufacturing, and Quality Operations teams.

Provide scientific guidance to development operations, and clinical and commercial QC teams. Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to current and future Cell Therapy Development operations and products.

Provide key strategic compliance and analytical development input to projects and cross-functional teams, including process development, manufacturing implementation, IMPD and IND preparation, and discussions with regulators.

Skills/Knowledge Required:

PhD/MS in Immunology, Biological Science, Biochemical Engineering, or related discipline with 8-10 yrs. R&D / analytical development experience, or BS with 15 yrs. R&D / analytical development experience in a relevant field.

Established track record of success, sound technical qualifications and depth knowledge in flow cytometry, ELISA, Cell culture. Cell therapy product characterization, method bridging, and other analytical technology experience a plus.

Solid understanding of the fundamentals of assay development, characterization, qualification, and transfer.

Understands cGMP documentation requirements. Skilled in writing and reviewing technical reports.

Familiarity with and constant attention to the evolving landscape through literature review/publication, conference attendance, industry working group leadership, etc.

Strategic thinker with excellent problem solving and conflict resolution skills.

Ability to foster a strong team-first environment with the ability to lead multiple projects.

Demonstrated success in leading high performing assay development teams.

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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com