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.
PURPOSE AND SCOPE OF POSITION:
The Senior Scientist will lead development of molecular assays (e.g. RT PCR, qPCR, ddPCR, NGS, NanoString, etc.) that characterize autologous and allogenic cell therapies that are currently undergoing clinical trials, including CAR T cell products. The Senior Scientist will be responsible for determining the appropriate technology platforms for methods, and the design, execution, and analyses of experiments that lead to the development of robust analytical methods. The Senior Scientist might be expected to lead 1-3 individuals. The Senior Scientist will be responsible for developing highly impactful methods, including QC methods that are used to release drug product to patients and extended characterization methods that are used to support manufacturing process development. 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 Scientist will have hands-on experience in assay development, have extensive project leadership experience, and will interested in driving projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. The Senior 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:
PhD in Biology, Cell Biology, Biochemistry, Immunology, or relevant discipline
Qualifications and Education Requirements
5+ years of relevant industry experience
Development and qualification/validation of molecular methods for use in a QC environment.
Proficiency with RT PCR, qPCR, ddPCR, and NanoString or other NGS single cell RNA sequencing technologies
Expert knowledge in discipline; supports technology assessments, method development strategies, and regulatory responses
Experienced training analysts and transferring analytical methods between analytical development and QC sites.
Experienced with authoring and revising test methods, protocols, and technical reports Automation experience
Proficient with cell culture, primary human cells, and cryopreservation
Experienced with genomic DNA and RNA extraction with both column and bead-based techniques
Good laboratory documentation skills
Outstanding written and oral communication skills
Work effectively in a collaborative team setting
Ability to work in a rapidly changing environment with frequent changes in priorities
Experience with MS Office suite of software
Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software.
Familiar with electronic laboratory notebook software
DUTIES AND RESPONSIBILITIES:
Subject matter expert for molecular methods who is responsible for developing compliant analytical methods, generating regulatory responses, and conducting technology assessments
RNA and DNA isolation from cellular material
Primer and probe design
Development of RT PCR, qPCR, ddPCR, and single cell RNA sequencing methods for a QC environment
Author, review and approve technical documents, including methods, protocols, reports, and SOPs
Manage all aspects of method development, qualification, validation, training, and transfer of analytical methods
Instrument and method troubleshooting
Maintain meticulous laboratory notebooks
Understanding of ICH/FDA/EMEA regulations and guidance
Management of up to 3 individuals
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.