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Bristol Myers Squibb Scientist, GQAS&T Biossay Immunoassay in Devens, Massachusetts

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Scientist with strong background and hands-on experience in cell-based potency, binding/immunoassays and impurity assays. Successful candidate will take leading role in defining new scientific approaches, facilitate method transfers and method qualifications and validations. Critical thinking, trouble-shooting and attention to detail is a must. Candidate will be required to plan & execute experiments as well as analyze data generated at other sites for method improvements. Ability to work collaboratively and across different functions in a fast-paced environment is required. Hands on Qualification/ Validation experience in compliance with regulatory requirements is highly desired.

Duties/Responsibilities:

  • Act as a technical resource for bioassay/immunoassay method development, qualification and validations.

  • Conduct periodic review of method performance; design and execute remediation experiments and implement changes.

  • Support method transfers to QC/GMP labs within and outside of BMS.

  • Act as a technical resource in investigations, health authority inquiries, and regulatory documents.

  • Assist in maintaining/qualification of critical reagent supply for assigned methods

  • Work collaboratively with Analytical Development and Quality teams to gather and analyze data to achieve method readiness.

  • Present work in team meetings, draft protocols, and summarize findings in technical reports.

  • Work across organization and sites for transfer, execution and trouble-shooting of commercial methods.

  • Participate in AS&T team goals to achieve safe and collective work environment

Required Knowledge/Skills/Qualifications

Education :

Bio-therapeutic development & industry experience required: BS or MS with 5-10 years or Ph.D. with 0-5 years of industry experience

Experience/Knowledge:

  • Hands-on experience developing potency assays in a variety of cellular systems is highly desired

  • Hands-on experience in Bioassay/immunoassay/Impurity assay development qualification and/or validation according to USP/ICH guidelines.

Skills/Competencies:

  • Strong communication skills in a highly interactive environment.

  • Demonstrated skills in working across-functional strategic teams and collaboration with internal and external partners. . .

  • Strong decision making skills

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our 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 with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol Myers Squibb

Req Number: R1527715-en-us

Updated: 2021-03-02 00:29:49.081 UTC

Location: Devens,Massachusetts

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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