Principal Scientist, QC Assay Automation, Cell Therapy in Devens, MA

Principal Scientist, Qc Assay Automation, Cell Therapy

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. 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.

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 Principal Scientist, QC Assay Automation, Cell Therapy is the subject matter expert leading implementation of state-of-art automation solutions for QC bioanalytical methods and technologies in autologous and allogenic cell therapy programs. Work collaboratively with internal and external stakeholders to ensure automation assay designs meet compliance and business requirements. Build effective relationships and work cross-functionally with internal and external stakeholders to implement novel integrated automated systems to streamline execution and analysis of cell therapy assays. Perform all functions related to automated assay technical transfer into the QC lab, including documentation associated with requirements gathering, development, IQ/OQ/PQ, and test method validation. Apply technical knowledge, regulatory requirements, and scientific principles to independently perform complex troubleshooting and problem solving.

Shifts Available: TBD

Responsibilities

• Subject matter expert for automated QC assays and systems, supporting the design and development of partial and integrated automation platforms for bioanalytical methods (e.g., cell-based assays, ELISA, qPCR, flow cytometry). Lead site implementation of automation systems into the GMP QC laboratory.
• Work with internal automation development team and external integration vendors to establish end-to-end integrated analytical automation platforms for GMP QC labs.
• Work collaboratively with internal and external stakeholders to ensure automation designs and assays meet compliance and business requirements.
• Perform all functions related to automated assay technical transfer into QC lab, including documentation associated with requirements gathering, development, IQ/OQ/PQ, and test method validation.
• SME for training and mentoring QC team on automation methods, processes, and procedures.
• Independently develop, write, and execute analytical automation 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). Own and author responses to regulatory requests.
• Review and approve laboratory investigations.
• Champion and foster a positive and successful collaborative quality culture.
• Conceptualize and lead complex projects, CAPAs, deviations, and continuous improvement efforts. Optimize automated assays, expand capabilities, and support technical investigations.
• Represent QC interest on cross functional/ cross-site teams and communicate and collaborate effectively.
• Apply technical knowledge, regulatory requirements, and scientific principles to perform troubleshooting and problem solving for non-routine complex issues.
• Perform other tasks as assigned.

Knowledge and Skills

• Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements.
• Demonstrated advanced technical writing skills.
• Advanced strategic thinking and 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 projects.
• Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally.
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.

Basic Requirements

• Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements.
• Demonstrated advanced technical writing skills.
• Advanced strategic thinking and 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 projects.
• Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally.
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.

The starting compensation for this job is a range from $124,590 - $151,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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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 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 a supportive culture, promoting global participation 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 an 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.