Bristol-Myers Squibb Company

Research Investigator

Location
Princeton, NJ, United States
Posted
Aug 09, 2019
Ref
R1517068
Required Education
Bachelors Degree
Position Type
Full time
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.

Summary

As a member of the Bioanalytical Sciences team, this Scientist will be primarily responsible for:

Development, validation and implementation of immunoassays for analysis of clinical and non-clinical immunogenicity and pharmacokinetics samples in a GLP like and GLP environment under the supervision of senior staff, with an emphasis on method development

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.

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

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.

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

The successful candidate will be self-motivated, have good interpersonal and communication skills, be able to multi-task, be highly organized, have a strong desire to succeed in a multifunctional team setting, proven ability to meet goals working in a group of peers, and proven innovative thinking.

Requirements BSc, MSc or PhD in relevant scientific discipline (biology, biochemistry, chemistry, cell biology etc.) with 2-6 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. Familiarity with setting bioanalytical strategies for biologics and responding to health authority queries is a plus. Knowledge of GLPs, 21 CFR Part 11, FDA and other relevant Bioanalytical Guidances is desirable. Good oral and written communication skills are required.

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.