Senior Research Investigator

Location
Princeton, NJ, United States
Posted
Sep 24, 2020
Ref
R1530303
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

As a member of the Non-clinical Disposition and Bioanalysis team, this Investigator will be primarily responsible for:
  • Developing bioanalytical strategies for various biologics development programs following internal SOPs and Health Authority guidances
  • Acting as the bioanalytical liaison with clinical, and non-clinical internal cross-functional project teams and external collaborators
  • Assisting in preparation of regulatory documents including INDs, NDAs, and BLA submission documents and being responsible for responding to Health Authority queries related to bioanalysis
  • Responsible to ensure development of high quality ligand binding assays used to support PK/PD/Immunogenicity assessments and subsequent validation and support of sample analysis.
  • Managing technology transfers of immunogenicity and PK methods and related bioanalytical activities (e.g., development data, validation and study reports) to contract research laboratories and ensuring the scientific quality of data in order to meet US and OUS regulatory expectations.
  • Performing technical audits of existing contract research laboratories supporting bioanalytical work
  • Reporting study sample results to stakeholders following the departmental policies and procedures and participate in tech transfers of assays to business partners and troubleshooting assays when problems arise.
  • Contributing to the preparation of technical reports and departmental SOPs and the preparation and presentation of scientific material at internal and external meetings and will be encouraged to publish as part of project publication plans.
  • Ensuring compliance and maintain required training in BMS and departmental SOPs, safety guidelines and other applicable regulations.
  • Achieving objectives in a manner consistent with the BMS Biopharm Behaviors.


Requirements

PhD in relevant scientific discipline (biology, biochemistry, chemistry, cell biology etc.) with 2-6 years of relevant experience, or MS in relevant scientific discipline with 5-10 years of relevant experience. The candidate should have proven technical expertise in developing and validating ligand binding assays in technologies such as ELISA, ECL (MSD) or Gyrolab. Experience in biological sample handling from clinical or animal studies in a regulated environment is required. Knowledge of GLPs, 21 CFR Part 11, FDA and other relevant Bioanalytical Guidances is desirable. Experience with cell-based assays for characterization of anti-drug antibodies, sample management systems and Watson LIMS is a plus. Good oral and written communication 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.