About this role
Senior Manager, Benchtop IT Systems at Devens Cell Therapy Facility overseeing benchtop/lab IT systems lifecycle with GxP/compliance focus.
Key Responsibilities
- Lead end-to-end lifecycle of benchtop and lab IT systems (LIMS, CDS, SDMS, ELN)
- Oversee system integration with manufacturing, quality, and enterprise platforms
- Ensure GxP, FDA, and regulatory standards are met in implementation and validation
- Partner with stakeholders to clarify user needs and drive bench-level digital solutions
- Manage vendor relationships and contractors
Technical Overview
Owns LIMS/CDS/SDMS/ELN validation, integration with manufacturing, data integrity, cybersecurity, vendor management, and lifecycle planning.
Ideal Candidate
The ideal candidate is a senior manager with 7+ years managing GMP/GxP-lab IT systems (LIMS, CDS, SDMS, ELN) with strong CSV and validation experience, in cell therapy/manufacturing.
Must-Have Skills
Bachelor's Degree (or higher) in Computer ScienceEngineeringLife Sciencesor related field7+ years of experience managing laboratory IT systems in a GMP or GxP-regulated pharmaceutical manufacturing or research environmentDeep knowledge of laboratory informatics systems (e.g.LIMSCDSSDMSELN) and corresponding validation requirementsDemonstrated experience leading complex IT or digital projectspreferably in biologics or cell therapy manufacturingStrong understanding of CSV (computer system validation)data integrityand regulatory requirements in laboratory environmentsProven leadershippeople managementand cross-functional project management skillsExcellent communicationorganizationaland stakeholder management abilities
Nice-to-Have Skills
Advanced Degree (MSPhDor MBA) in a relevant disciplineExperience delivering IT solutions for advanced therapy manufacturing/laboratoriesKnowledge of data analyticscloud platformscybersecurityand modern automation tools as applied to laboratory settingsExperience with global organizations and matrix reporting structures
Required Skills
LIMSCDSSDMSELNbenchtop IT systemsCSVGxPFDAvalidationSOPschange controlcybersecurityinformation security
Hard Skills
LIMSCDSSDMSELNbenchtop IT systemsCSVGxPFDAvalidationdocumentationSOPschange controlcybersecurityinformation securityvendor management
Soft Skills
leadershipcommunicationstakeholder managementcross-functional collaborationproject managementmentoring
Keywords for Your Resume
senior managerbenchtop it systemsdevens cell therapy facilitylimscdssdmselngxpfdavalidationcsvcsv validationcell therapybiologicsgxp regulationlifecyclevalidation plansopchange controlvendorsvendor managementcybersecurityinformation securitygxp compliantdocumentation
Deal Breakers
No GMP/GxP lab IT systems experience, No LIMS/CDS/SDMS/ELN experience, No CSV/validation experience
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