Sr. Research Scientist - CCIT
Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: January 11, 2020
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.Position SummaryWe 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
- 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
- Provide guidance and feedback to drug development teams and
regulatory functions responding to health authorities
- 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
- 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
- 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
- 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.
Keywords: Bristol-Myers Squibb Company, New Brunswick , Sr. Research Scientist - CCIT, Other , New Brunswick, New Jersey
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