Sr. Research Scientist - CCIT
- Employer
- Bristol Myers Squibb Company
- Location
- New Brunswick, NJ, United States
- Start date
- Oct 11, 2019
View more
- Discipline
- Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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.
Position Summary
We are seeking an analytical scientist with expertise in container closure integrity testing (CCIT), packaging components and delivery systems to support clinical aseptic manufacturing of small molecules and biologics.This includes method development and testing, line qualifications, technology transfer to commercial sites, new technology evaluation/implementation, and involvement in industry associations. This position resides in the Microbiology Center of Excellence Organization, and provides exciting opportunities to contribute to the development of drugs at the forefront of the industry
Position Responsibilities
- Work with stakeholders from development, clinical, commercial, and manufacturing organizations to develop phase appropriate CCIT methods and strategies to support drug product development.
- Develop/qualify/validate CCIT methods in support of aseptic manufacturing of clinical drug products and stability testing.
- Partner with device development and manufacturing groups to evaluate and implement rapid, non-destructive technologies to facilitate testing and manufacture of vials, syringes, and devices.
- Provide guidance and feedback to drug development teams and regulatory functions responding to health authorities worldwide.
- Perform hands on testing of CCI within the laboratory.
- Serve as a member of interdisciplinary development teams, providing scientific and operational input to product development plans.
- Provide guidance for work and train junior personnel.
- Contribute to contamination control strategy for final products as it relates to CCI.
- Utilize your knowledge of microbiology to evaluate novel CCIT methods for applicability to microbial ingress.
Desired Experience
Required:
- Bachelor Degree in Microbiology, Biological Sciences , Chemistry or related scientific discipline.
- 10 to 15 years of experience in analysis of pharmaceuticals, including at least 5 years with CCIT (dye ingress, helium leak, microbial challenge, HVLD, laser headspace, etc.).
- Demonstrated understanding of pharmaceutical analytical development, aseptic fill line operations, device development, process qualifications, and the impact of process/component changes on closure integrity and microbial ingress.
- Ability to interact and influence successfully across boundaries with other functional areas and disciplines.
- Effective multi-tasking and oral / written communications skills.
- Knowledge of regulatory guidance documents for CCIT.
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.
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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