Scientist Analytical Strategy amp Operations- Biologics GxP HPW

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.

Summary:

Versatile, biologics development GxP laboratory seeks a hard-working, results-focused Scientist with experience in protein analysis to bring a world-class R&D Biologics portfolio to market. This position will be a part of Analytical Strategy & Operations under the Product Development (PD) organization. The Scientist position will be located at the BMS New Brunswick (NBR) site in New Brunswick, NJ and directly report to a Laboratory Manager within the Biologics GxP - Bioseparations group.

DUTIES & RESPONSIBILITIES:

Essential Duties and Responsibilities include, but are not limited to, the following:


Independently perform biologics separation assays on monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs) and fixed drug ratio combination (FDRC) products to support clinical development of therapies, particularly against immuno-oncology (IO) and oncology diseases.

Execute electrophoretic-based and chromatography-based testing of biologics, including but not limited to CE-SDS, iCIEF, SE-HPLC, RP-HPLC, CEX, and peptide mapping analyses, as necessary, to support Research & Development (e.g. clinical release and stability, reference material qualification, and product development).

Demonstrate practical knowledge of analytical techniques to contribute to development of phase-appropriate, robust and reproducible analytical methods for use in the GMP clinical laboratory.

Independently execute analytical method qualification/validation (as applicable) and transfer to external QC laboratories. Carefully adhere to approved protocols, as applicable.

Perform duties in full compliance of relevant Good Laboratory Practice (GLP) or Good manufacturing Practice (GMP) regulations, corporate policies and site procedures.

Author clear, complete analytical methods and technical reports.

Review technical documents, reports and protocols to assure technical merit, accuracy and completeness.

Proactively provide clear, timely communication of potential issues to management.


Professional Qualifications:


The candidate must have a B.S. or equivalent with 6 or more years relevant experience or a M.S. with 4 or more years relevant experience in biotechnology/pharmaceutical industry with a degree in Analytical Chemistry, Chemistry, Biochemistry or equivalent. GMP laboratory experience is preferred.

Experience with electrophoretic-based and/or chromatography-based analysis is essential.

The candidate must have good written communication skills. Must be able to independently author and review analytical methods, qualification/validation protocols and technical reports.

Ability to identify, communicate and remediate technical issues pertaining to protein separation analytics is crucial. Skill in communicating/escalating critical issues to appropriate management is necessary.

Understanding of cGMP/GLP and GDPs practices and EHS requirements is essential. Ability to comply with all applicable SOPs, internal requirements and external regulations is necessary. Preferred candidate will have at least 2 years of experience in GMP environment.

Expertise using Empower, Electronic Laboratory Notebook (e.g. Velquest, Symyx), Laboratory Information Systems (LIMS) and MS Office applications, in particular MS Word and Excel, is preferred. Familiarity with electronic documentation systems (e.g. Syncade-DCA) for routing protocols/reports for review and approval is a plus.


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.

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