Research Scientist/ Research Investigator
- Employer
- Bristol Myers Squibb Company
- Location
- New Brunswick, NJ, US
- Start date
- Jan 26, 2019
View more
- Discipline
- Regulatory, Science/R&D, Biotechnology, Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Responsibilities:
- Effectively and independently designs and authors stability protocols based on knowledge of global stability guidelines to support clinical use and registration of biologics drug substances and products.
- Analyzes and trends stability data. Independently identifies issues and works with development team to resolve them. Clearly and effectively summarizes and presents results from stability studies and authors technical memos and reports.
- Contributes to scientific and technical discussions with team members and external collaborators to resolve issues and communicate conclusions from stability studies.
- Authors the stability section in investigational and registrational global filings. Develops strategy and authors responses to stability-related questions from health authorities within the established timelines.
- Proposes label storage statement and shelf life for drug substance and drug product.
- Manages protocol and stability data reports in LIMS.
- Serves as the stability subject matter expert in development teams through global registrations.
Qualifications
- BS/MS/PhD in chemistry, pharmacy/pharmaceutical sciences, or biochemistry
- 4 or more years of experience in the pharmaceutical industry, with experience in designing and writing stability protocols for investigational or registrational, studies for biologics, and in analyzing large sets of data.
- Applies ICH guidelines and other global regulations as they relate to stability to design complex, phase-appropriate stability protocols to support the intended purpose. Guides teams in establishing the stability strategy for the asset.
- Applies understanding and knowledge of pharmaceutics, pharmaceutical development and global stability guidelines to the development of stability protocols and the analysis of stability data. Serves as the stability SME in development teams.
- Analyzes large sets of biologics stability data and understands biologics laboratory test methods
- Authors stability sections of CTA's and registrational filings. Responds to health authority questions.
- Strong technical-written and verbal communication skills.
- Ability to prioritize and manage multiple large projects simultaneously and complete deliverables within established timelines.
- Understands documentation practices required for a cGMP regulated environment.
- Works independently in a complex, fast-paced, deadline driven environment
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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