Scientist, Biologics GXP Operations

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today. Working within Global Product Development and Supply this team uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.

Position Summary:

Versatile, biologics development GxP laboratory seeks a hard-working, results-focused Research & Development (R&D) scientist with experience in protein analysis to bring a world-class R&D Biologics portfolio to market. The scientist position will be located at the BMS New Brunswick (NBR) site in New Brunswick, NJ within the Biologics GxP - Compendial Testing Group.

Role & Responsibilities:

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

• Independently perform biologics 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 analytical testing of biologics including but not limited to compendial methods, wet chemistry techniques, Protein Concentration by UV/Vis spectroscopy (A280), Particulate Matter, and other relevant methods 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.
• Function as QC Subject Matter Expert (SME) to resolve technical issues and ensure appropriately robust and reliable GxP analytical methods are established for QC testing.
• 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.

Experience & Qualifications:

• Bachelor's degree and 5 -7 years of experience or Master's degree and 2-4 years of experience or Ph.D. and 0-2 years of experience
• Relevant experience should come from biotechnology/pharmaceutical industry with a degree in Analytical Chemistry, Chemistry, Biochemistry or equivalent.
• GMP laboratory experience is preferred.
• Experience with analysis of proteins in Research & Development environment 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.
• 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 a must. Preferred candidate will have at least 2 years of experience in GMP environment.
• Experience using Electronic Laboratory Notebook (e.g. Symyx), Laboratory Information Systems (LIMS) and MS Office applications, in particular MS Word and Excel, is preferred. Familiarity with electronic documentation systems for routing protocols/reports for review and approval is a plus.

Why You Should Apply

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.