Senior Scientst Biologics Methods Lifecycle

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:

At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.

Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.

We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate.

The Global Quality Analytical Sciences & Technology group is committed to supporting our global biologics analytical network with reliability, integrity, active engagement, and cross-functional collaboration. The Method Lifecycle Group in the Analytical Sciences and Technology department provides analytical oversight for the transition of programs entering the commercial space following clinical development. The Method Lifecycle Group is looking for an experienced Senior Scientist with demonstrated expertise and hands-on experience in biologics method lifecycle management. Experience with development, characterization, validation, and technical transfer of biologics is a plus. The successful candidate will bring experience working in technical teams and in a matrix environment supporting commercial biologics manufacturing and Quality. Expertise and hands-on experience developing, validating, and supporting physiochemical methods in a commercial QC environment with the following methods is a plus: Good hands-on knowledge and experience with Empower chromatography DCS is required. Knowledge of compendia methods and requirements as pertaining to biopharmaceuticals is expected. The successful candidate will participate in defining new scientific approaches and data analysis in a commercial environment. Critical thinking, expertise in trouble-shooting of analytical methods and equipment as well as attention to detail are a must. This is a part laboratory based and part office based role. Candidate will be required to plan & execute experiments as well as analyze data generated at other sites for method troubleshooting and improvements. Ability to work collaboratively and across different functions in fast-paced environment is required.

Duties/Responsibilities:

Provide technical oversight and ownership of physiochemical analytical methods.

Provide technical oversight and troubleshooting input to two or more of the methods listed (CE-SDS, iCIEF, ion exchange chromatography, peptide mapping)

Act as a representative of the group on different project teams

Understanding and supportive experience with control strategy and CQAs

Provide expert input during periodic review of method performance and work with team leader to design and execute remediation experiments and implement changes/revisions/improvements to existing commercial methods.

Author and review sections of regulatory filings.

Respond to Health Authority queries regarding analytical methods.

Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting in commercial environment.

Work closely with all AS&T team members to understand their deliverables to achieve organization goals.

Occasional method development and remediation work may be needed.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

Demonstrated troubleshooting abilities and hands-on experience with physiochemical methods.

Familiarity with protein characterization methods, structure-function studies, CQAs, and analytical control strategy.

Knowledge and understanding of regulatory guidelines including all major international guidelines (USP/ICH, EP, JP etc.).

Ability to lead complex technical projects

Understanding of method validation and transfer.

Experience of working with colleagues at remote sites.

Understanding of GMP principles is expected.

Ability to work independently.

Strong written and communication skills and experience working in a matrix organization.

Education/Experience/ Licenses/Certifications:

Bio-therapeutic development & industry experience required: BS with 10 years, MS with 6 years or Ph.D. with 4 years.

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

Bristol-Myers Squibb Company
Website : http://www.bms.com