Sr. Research Scientist - CCIT

Profile

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 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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

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