Principal Scientist, QC Automation, Cell Therapy - Bristol Myers Squibb
Devens, MA
About the Job
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 .
Position Summary:
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.
Key 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.
Qualifications & Experience:
+ Bachelor's degree or equivalent required, preferably in engineering, computer science, chemistry, or biology. Advanced degree preferred.
+ 10+ years of integrated automation experience. Experience working in a GMP QC laboratory preferred.
+ 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 leading development and implementation of automated laboratory workflows and high-throughput methods within the biotechnology or pharmaceutical industry is required. This includes systems configuration, liquid handling, and method programming.
+ Experience leading evaluation and implementation of new and novel technologies.
+ Experience with migration of bench techniques to hands-free automated systems is required.
+ Experience with Electronic Lab Notebook (ELN) and Lab Information Management Systems (LIMS) is required.
+ 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.
+ 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.
#LI-Onsite
#BMSCart
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586370
Updated: 2024-10-22 06:13:34.669 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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 .
Position Summary:
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.
Key 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.
Qualifications & Experience:
+ Bachelor's degree or equivalent required, preferably in engineering, computer science, chemistry, or biology. Advanced degree preferred.
+ 10+ years of integrated automation experience. Experience working in a GMP QC laboratory preferred.
+ 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 leading development and implementation of automated laboratory workflows and high-throughput methods within the biotechnology or pharmaceutical industry is required. This includes systems configuration, liquid handling, and method programming.
+ Experience leading evaluation and implementation of new and novel technologies.
+ Experience with migration of bench techniques to hands-free automated systems is required.
+ Experience with Electronic Lab Notebook (ELN) and Lab Information Management Systems (LIMS) is required.
+ 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.
+ 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.
#LI-Onsite
#BMSCart
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586370
Updated: 2024-10-22 06:13:34.669 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb
