Labvantage LIMS Technical Project Manager

$125,500 - $201,000/Yr

Moderna Therapeutics - Cambridge, MA

Full-time - Senior

Cambridge, MA

Professional, Scientific, and Technical Services

About the position

The Labvantage LIMS Sr. Technical Project Manager will play a crucial role in the Moderna Digital Laboratory Systems organization, reporting to the Director of Digital LIMS Systems. This position focuses on implementing new solutions and enhancing existing LabVantage systems, contributing to the strategic vision for the Quality Control Digital roadmap. The role demands leadership in managing fast-paced projects, ensuring integration with external systems, and delivering results that align with the company's goals.

Responsibilities

• Lead projects to improve functional, technical, configuration, and development for the Digital landscape supporting the QC laboratories.
• Act as the Technical Project Manager for the LabVantage LIMS integration with external systems.
• Manage fast-phase projects and deliver results as expected.
• Provide leadership and architectural knowledge within large cross-functional projects.
• Propose, lead, and deploy small and medium-size continuous improvement projects within the Lab Systems.
• Independently deliver projects and initiatives in a timely and qualitative manner.
• Highlight potential risks and act proactively to resolve issues.
• Participate in the demand management process to assist the business in establishing business cases relating to new systems or potential system changes.
• Work independently to author System Configuration Specification, System Administration SOP, execute test scripts following cGxP.
• Author, review, and approve lifecycle documents like Impact assessment, Regulatory applicability, and criticality assessments, ERES assessments, etc.
• Work with the Lab Automation team to interface the standalone systems with LIMS.
• Assist in evaluation of product enhancements and capabilities, implementing upgrades as required.
• Support initial and routine upgrade system risk assessment and testing activities.

Requirements

• A bachelor's degree in STEM or another relevant academic discipline required.
• A minimum of 10 years of industry experience implementing and maintaining laboratory systems.
• Must have 5+ years of experience working with LabVantage LIMS and Application Integration.
• Must have experience working with Instrument integration to LabVantage LIMS.
• Experience authoring and reviewing computer system validation lifecycle documents.
• Working understanding of cGMP and manufacturing operations and practices.
• Strong communication skills (verbal and written).
• Demonstrated ability to work independently and collaboratively in cross-functional teams.
• Compliance-focused mindset.

Nice-to-haves

• Working understanding of cGMP and manufacturing operations and practices.
• An understanding of computer systems validation practices (GAMP).
• Strong communication skills (verbal and written).
• Demonstrated ability to work independently and collaboratively on cross-functional teams.
• Experience working in a matrixed environment.
• A desire to make an impact as part of a high-growth, transformational company.

Benefits

• Comprehensive incentive compensation package including an annual cash bonus.
• New hire equity and an annual refresh.
• 401(k) match.
• Competitive and inclusive medical, dental, and vision coverage options.
• Flexible spending accounts for medical and dependent care.
• Life, LTD, and STD insurance.
• Family leave offerings, including at least 18 weeks of 100% paid parental leave.
• Lifestyle spending account, adoption, surrogacy, and family-planning benefits.
• Generous paid time off, including vacation, sick time, and observed company-wide holidays.
• Paid volunteer time to participate within your community.
• Discretionary winter holiday shutdown.
• Paid 4-week sabbatical after 5 years, and every 3 years after.