Senior Manager, Benchtop IT Systems – Devens Cell Therapy Facility
Bristol-Myers Squibb
Senior Manager, Benchtop IT Systems – Devens Cell Therapy Facility
Job Description
Lead and manage the end-to-end lifecycle of benchtop and laboratory IT systems (LIMS, CDS, SDMS, ELN, bespoke instrument software) within the Cell Therapy Facility, including requirements gathering, design, implementation, validation, and ongoing support. Oversee system integration with manufacturing, quality, and enterprise platforms, ensuring seamless data flow and strong information security. Ensure strict adherence to GxP, FDA, and other applicable regulatory standards in system implementation, validation, and operations. Partner with internal stakeholders (lab users, engineers, QA, manufacturing) to clarify user needs, recommend scalable solutions, and drive digital innovation at the bench level. Direct vendor relationships and manage contractors supporting laboratory IT systems, including service level agreements and performance monitoring. Monitor system performance and proactively resolve incidents, collaborating closely with global support teams. Develop and maintain robust documentation, validation plans, SOPs, and change control records for laboratory IT systems. Drive continuous improvement initiatives, including system upgrades, user training, cybersecurity enhancements, and lifecycle planning. Effectively manage operational budgets, resources, and schedules, tracking and reporting progress to site leadership and global IT function. Provide leadership, coaching, and mentorship to direct reports and cross-functional project teams. 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. Bachelor's Degree (or higher) in Computer Science, Engineering, Life Sciences, or related field. 7+ years of experience managing laboratory IT systems in a GMP or GxP-regulated pharmaceutical manufacturing or research environment. Deep knowledge of laboratory informatics systems (e.g., LIMS, CDS, SDMS, ELN) and corresponding validation requirements. Demonstrated experience leading complex IT or digital projects, preferably in biologics or cell therapy manufacturing. Strong understanding of CSV (computer system validation), data integrity, and regulatory requirements in laboratory environments. Proven leadership, people management, and cross-functional project management skills. Excellent communication, organizational, and stakeholder management abilities. Advanced Degree (MS, PhD, or MBA) in a relevant discipline. Experience delivering IT solutions for advanced therapy manufacturing/laboratories (cell, gene therapy, biologics). Knowledge of data analytics, cloud platforms, cybersecurity, and modern automation tools as applied to laboratory settings. Experience with global organizations and matrix reporting structures.
Key Responsibilities
- Lead and manage the end-to-end lifecycle of benchtop and laboratory IT systems within the Cell Therapy Facility
- Oversee system integration with manufacturing, quality, and enterprise platforms
- Ensure strict adherence to GxP, FDA, and other applicable regulatory standards in system implementation, validation, and operations
- Partner with internal stakeholders to clarify user needs, recommend scalable solutions, and drive digital innovation
- Direct vendor relationships and manage contractors supporting laboratory IT systems
- Monitor system performance and proactively resolve incidents
- Develop and maintain robust documentation, validation plans, SOPs, and change control records
- Drive continuous improvement initiatives, including system upgrades, user training, cybersecurity enhancements, and lifecycle planning
- Effectively manage operational budgets, resources, and schedules
- Track and report progress to site leadership and global IT function
- Provide leadership, coaching, and mentorship to direct reports and cross-functional project teams
Required Qualifications
- Bachelor's Degree (or higher) in Computer Science, Engineering, Life Sciences, or related field
- + years of experience managing laboratory IT systems in a GMP or GxP-regulated pharmaceutical manufacturing or research environment
- Deep knowledge of laboratory informatics systems (e.g., LIMS, CDS, SDMS, ELN) and corresponding validation requirements
- Demonstrated experience leading complex IT or digital projects, preferably in biologics or cell therapy manufacturing
- Strong understanding of CSV (computer system validation), data integrity, and regulatory requirements in laboratory environments
- Proven leadership, people management, and cross-functional project management skills
- Excellent communication, organizational, and stakeholder management abilities
Preferred Qualifications
- Advanced Degree (MS, PhD, or MBA) in a relevant discipline
- Experience delivering IT solutions for advanced therapy manufacturing/laboratories (cell, gene therapy, biologics)
- Knowledge of data analytics, cloud platforms, cybersecurity, and modern automation tools as applied to laboratory settings
- Experience with global organizations and matrix reporting structures
Skills Required
- Technical skills in laboratory informatics systems (LIMS, CDS, SDMS, ELN)
- Ability to manage complex IT or digital projects
- Knowledge of CSV, data integrity, and regulatory requirements
- Leadership and people management skills
- Cross-functional project management skills
- Excellent communication and organizational skills
- Stakeholder management abilities
Benefits & Perks
- 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
- Summer hours flexibility
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Technical skills in laboratory informatics systems (LIMS, CDS, SDMS, ELN)intermediate
- Ability to manage complex IT or digital projectsintermediate
- Knowledge of CSV, data integrity, and regulatory requirementsintermediate
- Leadership and people management skillsintermediate
- Cross-functional project management skillsintermediate
- Excellent communication and organizational skillsintermediate
- Stakeholder management abilitiesintermediate
Required Qualifications
- Bachelor's Degree (or higher) in Computer Science, Engineering, Life Sciences, or related field (experience)
- + years of experience managing laboratory IT systems in a GMP or GxP-regulated pharmaceutical manufacturing or research environment (experience)
- Deep knowledge of laboratory informatics systems (e.g., LIMS, CDS, SDMS, ELN) and corresponding validation requirements (experience)
- Demonstrated experience leading complex IT or digital projects, preferably in biologics or cell therapy manufacturing (experience)
- Strong understanding of CSV (computer system validation), data integrity, and regulatory requirements in laboratory environments (experience)
- Proven leadership, people management, and cross-functional project management skills (experience)
- Excellent communication, organizational, and stakeholder management abilities (experience)
Preferred Qualifications
- Advanced Degree (MS, PhD, or MBA) in a relevant discipline (experience)
- Experience delivering IT solutions for advanced therapy manufacturing/laboratories (cell, gene therapy, biologics) (experience)
- Knowledge of data analytics, cloud platforms, cybersecurity, and modern automation tools as applied to laboratory settings (experience)
- Experience with global organizations and matrix reporting structures (experience)
Responsibilities
- Lead and manage the end-to-end lifecycle of benchtop and laboratory IT systems within the Cell Therapy Facility
- Oversee system integration with manufacturing, quality, and enterprise platforms
- Ensure strict adherence to GxP, FDA, and other applicable regulatory standards in system implementation, validation, and operations
- Partner with internal stakeholders to clarify user needs, recommend scalable solutions, and drive digital innovation
- Direct vendor relationships and manage contractors supporting laboratory IT systems
- Monitor system performance and proactively resolve incidents
- Develop and maintain robust documentation, validation plans, SOPs, and change control records
- Drive continuous improvement initiatives, including system upgrades, user training, cybersecurity enhancements, and lifecycle planning
- Effectively manage operational budgets, resources, and schedules
- Track and report progress to site leadership and global IT function
- Provide leadership, coaching, and mentorship to direct reports and cross-functional project teams
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Senior Manager, Benchtop IT Systems – Devens Cell Therapy Facility
Bristol-Myers Squibb
Senior Manager, Benchtop IT Systems – Devens Cell Therapy Facility
Job Description
Lead and manage the end-to-end lifecycle of benchtop and laboratory IT systems (LIMS, CDS, SDMS, ELN, bespoke instrument software) within the Cell Therapy Facility, including requirements gathering, design, implementation, validation, and ongoing support. Oversee system integration with manufacturing, quality, and enterprise platforms, ensuring seamless data flow and strong information security. Ensure strict adherence to GxP, FDA, and other applicable regulatory standards in system implementation, validation, and operations. Partner with internal stakeholders (lab users, engineers, QA, manufacturing) to clarify user needs, recommend scalable solutions, and drive digital innovation at the bench level. Direct vendor relationships and manage contractors supporting laboratory IT systems, including service level agreements and performance monitoring. Monitor system performance and proactively resolve incidents, collaborating closely with global support teams. Develop and maintain robust documentation, validation plans, SOPs, and change control records for laboratory IT systems. Drive continuous improvement initiatives, including system upgrades, user training, cybersecurity enhancements, and lifecycle planning. Effectively manage operational budgets, resources, and schedules, tracking and reporting progress to site leadership and global IT function. Provide leadership, coaching, and mentorship to direct reports and cross-functional project teams. 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. Bachelor's Degree (or higher) in Computer Science, Engineering, Life Sciences, or related field. 7+ years of experience managing laboratory IT systems in a GMP or GxP-regulated pharmaceutical manufacturing or research environment. Deep knowledge of laboratory informatics systems (e.g., LIMS, CDS, SDMS, ELN) and corresponding validation requirements. Demonstrated experience leading complex IT or digital projects, preferably in biologics or cell therapy manufacturing. Strong understanding of CSV (computer system validation), data integrity, and regulatory requirements in laboratory environments. Proven leadership, people management, and cross-functional project management skills. Excellent communication, organizational, and stakeholder management abilities. Advanced Degree (MS, PhD, or MBA) in a relevant discipline. Experience delivering IT solutions for advanced therapy manufacturing/laboratories (cell, gene therapy, biologics). Knowledge of data analytics, cloud platforms, cybersecurity, and modern automation tools as applied to laboratory settings. Experience with global organizations and matrix reporting structures.
Key Responsibilities
- Lead and manage the end-to-end lifecycle of benchtop and laboratory IT systems within the Cell Therapy Facility
- Oversee system integration with manufacturing, quality, and enterprise platforms
- Ensure strict adherence to GxP, FDA, and other applicable regulatory standards in system implementation, validation, and operations
- Partner with internal stakeholders to clarify user needs, recommend scalable solutions, and drive digital innovation
- Direct vendor relationships and manage contractors supporting laboratory IT systems
- Monitor system performance and proactively resolve incidents
- Develop and maintain robust documentation, validation plans, SOPs, and change control records
- Drive continuous improvement initiatives, including system upgrades, user training, cybersecurity enhancements, and lifecycle planning
- Effectively manage operational budgets, resources, and schedules
- Track and report progress to site leadership and global IT function
- Provide leadership, coaching, and mentorship to direct reports and cross-functional project teams
Required Qualifications
- Bachelor's Degree (or higher) in Computer Science, Engineering, Life Sciences, or related field
- + years of experience managing laboratory IT systems in a GMP or GxP-regulated pharmaceutical manufacturing or research environment
- Deep knowledge of laboratory informatics systems (e.g., LIMS, CDS, SDMS, ELN) and corresponding validation requirements
- Demonstrated experience leading complex IT or digital projects, preferably in biologics or cell therapy manufacturing
- Strong understanding of CSV (computer system validation), data integrity, and regulatory requirements in laboratory environments
- Proven leadership, people management, and cross-functional project management skills
- Excellent communication, organizational, and stakeholder management abilities
Preferred Qualifications
- Advanced Degree (MS, PhD, or MBA) in a relevant discipline
- Experience delivering IT solutions for advanced therapy manufacturing/laboratories (cell, gene therapy, biologics)
- Knowledge of data analytics, cloud platforms, cybersecurity, and modern automation tools as applied to laboratory settings
- Experience with global organizations and matrix reporting structures
Skills Required
- Technical skills in laboratory informatics systems (LIMS, CDS, SDMS, ELN)
- Ability to manage complex IT or digital projects
- Knowledge of CSV, data integrity, and regulatory requirements
- Leadership and people management skills
- Cross-functional project management skills
- Excellent communication and organizational skills
- Stakeholder management abilities
Benefits & Perks
- 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
- Summer hours flexibility
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Technical skills in laboratory informatics systems (LIMS, CDS, SDMS, ELN)intermediate
- Ability to manage complex IT or digital projectsintermediate
- Knowledge of CSV, data integrity, and regulatory requirementsintermediate
- Leadership and people management skillsintermediate
- Cross-functional project management skillsintermediate
- Excellent communication and organizational skillsintermediate
- Stakeholder management abilitiesintermediate
Required Qualifications
- Bachelor's Degree (or higher) in Computer Science, Engineering, Life Sciences, or related field (experience)
- + years of experience managing laboratory IT systems in a GMP or GxP-regulated pharmaceutical manufacturing or research environment (experience)
- Deep knowledge of laboratory informatics systems (e.g., LIMS, CDS, SDMS, ELN) and corresponding validation requirements (experience)
- Demonstrated experience leading complex IT or digital projects, preferably in biologics or cell therapy manufacturing (experience)
- Strong understanding of CSV (computer system validation), data integrity, and regulatory requirements in laboratory environments (experience)
- Proven leadership, people management, and cross-functional project management skills (experience)
- Excellent communication, organizational, and stakeholder management abilities (experience)
Preferred Qualifications
- Advanced Degree (MS, PhD, or MBA) in a relevant discipline (experience)
- Experience delivering IT solutions for advanced therapy manufacturing/laboratories (cell, gene therapy, biologics) (experience)
- Knowledge of data analytics, cloud platforms, cybersecurity, and modern automation tools as applied to laboratory settings (experience)
- Experience with global organizations and matrix reporting structures (experience)
Responsibilities
- Lead and manage the end-to-end lifecycle of benchtop and laboratory IT systems within the Cell Therapy Facility
- Oversee system integration with manufacturing, quality, and enterprise platforms
- Ensure strict adherence to GxP, FDA, and other applicable regulatory standards in system implementation, validation, and operations
- Partner with internal stakeholders to clarify user needs, recommend scalable solutions, and drive digital innovation
- Direct vendor relationships and manage contractors supporting laboratory IT systems
- Monitor system performance and proactively resolve incidents
- Develop and maintain robust documentation, validation plans, SOPs, and change control records
- Drive continuous improvement initiatives, including system upgrades, user training, cybersecurity enhancements, and lifecycle planning
- Effectively manage operational budgets, resources, and schedules
- Track and report progress to site leadership and global IT function
- Provide leadership, coaching, and mentorship to direct reports and cross-functional project teams
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Senior Manager, Benchtop IT Systems – Devens Cell Therapy Facility @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs