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Senior Scientist, Clinical QC Bioanalytical

4 months ago

New York, New York, United States Bristol Myers Squibb Full time
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: .

Title: Senior Scientist, Clinical QC Bioanalytical

Location: Warren, NJ

At Bristol Myers Squibb we are reimagining the future of cell therapy . With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

The Senior Scientist, Clinical QC Bioanalytical will be a subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. This individual will apply technical knowledge, regulatory requirements, and scientific principles to perform complex troubleshooting and problem solving. They will also be responsible for leading projects, document revisions, deviations/investigations/CAPA, and continuous improvement efforts.

Key Responsibilities:Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples.Apply technical knowledge, regulatory requirements, and scientific principles to perform troubleshooting and problem solving for nonroutine complex issues.Perform data verification, data review and review of GMP documentation for general and complex methods.Subject matter expert for training others on test methods and complex processes.Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.Represent the department in product review boards, regulatory inspections (internal and external audits). May author responses to regulatory requests.Lead project, CAPA and deviation/ investigation and/ or continuous improvement efforts.Train and mentor others on multiple complex QC test methods, processes, and procedures.Champion and foster a positive and successful collaborative quality culture.Perform other tasks as assigned.Qualifications & Experience:Bachelor's degree or equivalent required, preferably in science. Advanced degree preferred.8+ years of relevant analytical testing, including 2+ years of QC experience, or an equivalent combination of education and experience.Advanced experience with various bioanalytical techniques (e.g., cell-based assays, ELISA, qPCR, flow cytometry) and scientific knowledge in the characterization, validation, and transfer of bioanalytical methods.Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements.Demonstrated advanced technical writing skills.Advanced problem-solving ability/mentality, technically adept and logical.Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple complex projects.Advanced ability to communicate and collaborate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs, locally and globally.Demonstrated strategic thinking.Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.#LI-Onsite

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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 scienceTM , 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 . Visit 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.