Scientist - Analytical Strategy & Operations- Biologics GxP, HPW
Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: January 7, 2021
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
- 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
- Demonstrate practical knowledge of analytical techniques to
contribute to development of phase-appropriate, robust and
reproducible analytical methods for use in the GMP clinical
- Independently execute analytical method
qualification/validation (as applicable) and transfer to external
QC laboratories. Carefully adhere to approved protocols, as
- 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
- 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
- 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
- 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.
Keywords: Bristol Myers Squibb, New Brunswick , Scientist - Analytical Strategy & Operations- Biologics GxP, HPW, Other , New Brunswick, New Jersey
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