Senior Associate Scientist Analytical Development

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.

Product Potency and Function group, a newly formed interdisciplinary group within the Product and Analytical Development unit of BMS, is seeking applications from a highly motivated individual for Senior Associate Scientist position. This individual will be highly knowledgeable with demonstrated experience in nucleic acid methods, chemistry, and assay development. The Senior Associate Scientist will develop molecular assays including but not limited to qPCR, ddPCR, and probe-based assays that characterize the autologous and allogenic cell therapies which are currently undergoing clinical trials, including CAR T cell products. The Senior Associate Scientist will design, execute, and analyze experiments that lead to the development of robust analytical methods without oversight. The Senior Associate Scientist will have the responsibility for developing highly impactful methods, including QC methods for lot release & stability testing as well as extended characterization methods that support process development and comparability assessments. These methods will be used to further understanding of cell therapies, support development of the manufacturing processes, and/or QC release of the drug product. The Senior Associate Scientist will have a strong background in assay development and will have experience in projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. This is a non-GxP role that requires hands-on assay development expertise and a familiarity with the components of the analytical development lifecycle as it relates to cell therapy development. The Senior Associate Scientist will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of likeminded Scientists.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

BS in Molecular biology, Microbiology, Chemistry, Immunology, Cancer Biology, or related field

Experience

Qualifications and Education Requirements


BS with 16 years of experience or MS with 8 to 12 years of experience in the field of Molecular biology, Microbiology, Chemistry, Immunology, Cell Biology, or Cancer Biology, preferably in an industry setting

Expertise developing molecular analytical methods including but not limited to nucleic acid based (PCR, qPCR, ddPCR, NanoString)

Experience with analysis and interpretation of complex datasets using statistical tools such as JMP

Experience with cell culture, primary human cells, and cryopreservation.

Proficiency developing novel molecular methods, robustness assessments, establishing system suitability criteria, critical reagent qualification procedures, analyst training, method transfers, and/or method qualification/validation.

Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software.

Experience training and guiding junior scientists and technicians in the lab


Preferred Qualifications


Proficiency with relative potency methods, 4-PL, robustness assessments, establishing system suitability criteria, critical reagent qualification procedures, analyst training, method transfers, and/or method qualification/validation.

Experience with aptamer-based assay development.

Experience with fluorescence microscopy, live cell imaging and analysis (i.e. IncuCyte), and/or image cytometry.


DUTIES AND RESPONSIBILITIES:


Emphasis on hands-on leadership, ownership qualities, and fostering a creative, collaborative, and accountable working environment.

Responsibility for the development of cell-based immunoassays and next-generation functional interrogation techniques.

Deliver lifecycle-appropriate analytics methods for multiple programs, with an understanding of ICH/FDA/EMEA/analytical working group best practices and current thinking.

Author, review and approve technical documents, including reports, SOPS, and draft documentation for regulatory filings (IND/BLA, CTA/MAA, etc.)


WORKING CONDITIONS (US Only):


Office and laboratory environments with a mix of natural and LED lighting with low level of background noise. Required computer and conferencing hardware are provided. 40% seated at a desk with ergonomic and sit/stand desks and 60% time in laboratory or meetings.

Local, national, and international travel up to 25%

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.


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.

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