Principal Engineer, QC Automation, Cell Therapy

Bristol Myers Squibb•Devens, MA

23h

About The Position

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 designs meet compliance and business requirements. Build effective relationships/partnerships 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 automation 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.

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.
Bachelor’s degree or equivalent required, preferably in engineering, computer science, chemistry, or biology.
5+ years of integrated automation experience.
Demonstrated automation developer experience in automated liquid handlers, end-to-end assay automation workflows and integrated automation systems.
Experience designing, programming, operating, and troubleshooting end-to-end integrated automation systems, such as Biosero, HighRes® Biosolutions, Hamilton, or Thermo Scientific™ is required.
Experience with Electronic Lab Notebook (ELN) and Lab Information Management Systems (LIMS) is required.
Experience with migration of bench techniques to hands-free automated systems is required.

Nice To Haves

Advanced degree preferred.
Experience working in a GMP QC laboratory preferred.
Experience leading development and implementation of automated laboratory workflows and high-throughput methods within the biotechnology or pharmaceutical industry is preferred. This includes systems configuration, liquid handling, and method programming.
Experience leading evaluation and implementation of new and novel technologies.
Experience with various programming languages, such as Python, Visual Basic, C, C++, etc. is preferred.
Experience with analytical method (ELISA, flow cytometry, qPCR) development is preferred.

Responsibilities

Site lead and subject matter expert for QC automation systems, supporting the design and development of partial and integrated automation platforms for bioanalytical methods.
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 meet compliance and business requirements.
Perform all functions related to automation 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 systems, 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.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

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