Senior Principle Engineer, Assay and Data Automation, Cell Therapy

$143,000 - $179,000/Yr

Bristol-Myers Squibb - Seattle, WA

Full-time - Senior

Seattle, WA

Chemical Manufacturing

About the position

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. The Senior Principle Engineer will join our Assay and Data Automation team, providing analytical and data automation development oversight for external contract partners. This role is critical as it involves acting as a technical lead in a matrix team, overseeing collaboration with contract development and manufacturing organizations (CDMO) on the development of analytical automation platforms and data integration solutions for cell therapy product testing. The successful candidate will work closely with internal technical and quality functions to ensure that the strategy related to the development of the analytical automation platform from external contract partners meets analytical criticality and successfully demonstrates comparability to the current analytical platform. The primary focus will be on ensuring the successful implementation and utilization of automated analytical platforms and data integration solutions in GMP labs, while ensuring quality, compliance, and timely delivery of analytical data and reports. This position requires strong leadership, technical expertise in analytical and data automation, and the ability to effectively influence a broad range of stakeholders in a fast-paced environment.

Responsibilities

• Serve as the primary point of contact for all automation-related analytical development activities conducted by CDMO, representing the BMS technical team.
• Work closely with CDMO on developing strategies for the automation of analytical methods, data acquisition, and data analysis, ensuring efficiency, accuracy, and compliance.
• Provide technical oversight and guidance to CDMO in developing and implementing automation solutions for QC testing, ensuring adherence to established automation protocols, methods, and regulatory requirements.
• Review and approve automated analytical development data and reports generated by external labs, ensuring accuracy, completeness, and compliance with internal and regulatory standards.
• Monitor project timelines and deliverables related to analytical automation development, proactively identifying and addressing any potential issues or delays.
• Represent CTAD as part of the CMC matrix team to drive the success of development and implementation of analytical and data automation in GMP labs.
• Establish and maintain strong relationships with external partners, ensuring effective communication and collaboration.
• Collaborate with cross-functional teams, including CATD teams, CMC, Analytical Science and Technology (AS&T), Quality Control, Regulatory Affairs, and Project Management, to ensure alignment and successful execution of automation projects.

Requirements

• Bachelor's degree in a scientific discipline (Biomedical Engineering, Biological Sciences, Biochemistry or related field). Advanced degree preferred.
• 8+ years of experience with development and implementation of automated laboratory workflows within the biotechnology or pharmaceutical industry, GMP environment preferred.
• Strong knowledge of automation design, development, and deployment in GMP and non-GMP labs.
• In-depth understanding of regulatory guidelines and requirements (e.g., FDA, ICH) related to analytical development and GMP compliance in the context of automation.
• Experience in cell therapy analytical development and molecular-based, cell-based, and flow cytometry-based assays.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders with a focus on delivering high-quality results within established timelines.
• Strong organizational and project management abilities, with a focus on delivering high-quality results within established timelines.
• Demonstrated ability for technical and business decision making and to think strategically while working effectively in a matrix team.
• Ability to adapt to changing priorities and work effectively in a fast-paced, dynamic environment.

Benefits

• 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 including 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
• Tuition reimbursement and a recognition program