Full-timeEstimated: $76,000 - $100,000 a year
- Communication Skills
- Doctoral Degree
- Master's Degree
Full Job Description
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.
The successful candidate will be part of the Analytical Regulated Testing GMP team at BMS New Brunswick New Jersey within Analytical Strategy & Operations. The scientist performs analytical method validation and cGMP activities and provides oversight and strategy to support clinical and commercial development for small molecule New Chemical entities and Investigational Medicinal Product.
Performs analytical cGMP activities and provide technical expertise for evaluation and feedback of methods.
Provides technical expertise and troubleshooting for technical problems and investigations.
Participates in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs.
Technology transfer of analytical methods to external BMS partners
Provides input into audit readiness and expertise for Internal and regulatory inspections.
Effective collaboration and communication with theCMC sub teams to ensure all API and drug product release testing, stability testing and filing requirements meet associated clinical timelines.
PhD or MS degree in analytical chemistry, organic chemistry, biochemistry or Pharmacy with more than >3 years relevant industrial experience or equivalent.
Demonstrated knowledge of the IND and NDA validation and troubleshooting of chromatographic separation methods used to analyze API and drug product.
Excellent interpersonal communication skills with capability of interfacing with and influencing multi-disciplinary teams.
Experience with regulatory submissions and interaction with regulatory agency inspectors.
Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.
Demonstrates ability to prioritize project responsibilities to meet competing requirements.
Ability to adapt to change, manage multiple projects effectively meeting timelines.
Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.
Able to identify opportunities and implement solutions to improve efficiency, productivity and quality/compliance.
Strong verbal and written communication skills to effectively communicate with key partners both internally and externally.
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.