Senior Research Investigator/Scientist
- Employer
- Bristol Myers Squibb Company
- Location
- Princeton, NJ, United States
- Start date
- Jul 9, 2019
View more
- Discipline
- Regulatory, Research/Documentation, Science/R&D, Research
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.
Job Description:
- Developing bioanalytical strategies for various biologics programs following internal SOPs and Health Authority guidance.
- 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
- Developing or overseeing development and validation of high quality ligand binding assays in support of PK/PD/Immunogenicity assessments.
- 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 health authority regulatory expectations.
- Performing as needed technical audits of existing contract research laboratories supporting bioanalytical work
- Contributing to the preparation of technical reports and departmental SOPs and the preparation and presentation of scientific material at internal and external meetings. The successful candidate will be encouraged to publish as part of project publication plans.
- Ensuring compliance with training requirements at BMS and departmental SOPs, safety guidelines and other applicable regulations.
- Achieving objectives in a manner consistent with the BMS Biopharma Behaviors.
- The successful candidate will be self-motivated with good interpersonal and communication skills, and be able to multi-task while meeting objectives in a matrix environment.
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 with cell-based assays relevant to the characterization of anti-drug antibodies, sample management systems and Watson LIMS is a plus.
- 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
- Good oral and written communication skills are required.
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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