Associate Research Scientist
Bristol-Myers Squibb Company
New Brunswick, New Jersey, United States
Job type: fulltime
Job industry: Science & Technology
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.
- Collaborates with formulation and manufacturing colleagues in order to optimize processes and improve productivity.
- Conducts testing as per assigned technique and methods.
- Documents work in laboratory notebooks and other systems and as per GMPs and department SOPs.
- Performs data review of instrument related documentation, analytical results as well as outsourced analysis.
- Acquires reviews and/or approves in GMP compliant manner, data related to methods development and testing of GMP and development materials. Prepares reports for methods, validation, and technology transfer.
- Transfers methods to development labs and CROs
- Sustains up to date knowledge on applicable department and site standard practices related to GMPs, safety and controlled substances as appropriate to work.
- Provides input, and may author standard practices.
- Assists in purchase and implementation of new technology
- Participates in laboratory investigations/inspections.
- Conducts Microbiology Investigations and implement CAPAs as needed
- Serves as a member of interdisciplinary development teams, providing scientific and operational input to development plans
- Drafts responses and corrective actions to internal compliance questions related to their work.
- Writes and revises SOPs, WIs and Methods as needed.
- Writes and implement change controls.
- Desired Experience Bachelor Degree in Microbiology or related scientific discipline with 3 to 7 years' experience in pharmaceutical microbiology.
- Good communication skills, both written and verbal, are required.
- Experience with environmental monitoring, water testing, bacterial endotoxin test, bioburden and sterility, with in-depth understanding of the method.
- Knowledge of basic compendial microbial test methods is required.
- Experience with instrument qualifications in a microbiology environment is a plus.
- Detail oriented and able to deal with changing priorities.
- Demonstrated ability to solve non-routine analytical issues and provide guidance to laboratory and external 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 the resources to pursue their goals, both at work and in their personal lives.