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 report to and work closely with the Director of Digital LIMS Systems to ensure the implementation of new solutions and improvement of existing systems (LabVantage) for the Moderna Digital Laboratory Systems organization. This role is pivotal in shaping and delivering the long-term strategic vision for the Quality Control Digital roadmap. The position operates from various locations including Cambridge, Norwood, Seattle, or New Jersey, reflecting the fast-paced and dynamic environment of Moderna. In this role, you will lead projects aimed at enhancing the functional, technical, configuration, and development aspects of the Digital landscape that supports the Quality Control laboratories. As the Technical Project Manager for the LabVantage LIMS integration with external systems, you will manage fast-paced projects and ensure timely delivery of results. Your leadership will be crucial in large cross-functional projects, where you will provide architectural knowledge and guidance. You will be responsible for proposing, leading, and deploying small to medium-sized continuous improvement projects within the Lab Systems. This includes independently delivering projects and initiatives while highlighting potential risks and proactively resolving issues. You will also participate in the demand management process, assisting the business in establishing business cases for new systems or potential system changes. Your role will involve authoring System Configuration Specifications, System Administration SOPs, and executing test scripts in accordance with cGxP standards. You will be tasked with authoring, reviewing, and approving lifecycle documents such as Impact assessments, Regulatory applicability, and criticality assessments, as well as ERES assessments. Collaboration with the Lab Automation team will be essential to interface standalone systems with LIMS, and you will assist in evaluating product enhancements and capabilities, implementing necessary upgrades. Additionally, you will support initial and routine upgrade system risk assessments and testing activities.

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-paced projects and deliver results as expected.
• Provide leadership and architectural knowledge within large cross-functional projects.
• Propose, lead, and deploy small and medium-sized 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 that is Bold, Relentless, Curious, and Collaborative.

Benefits

• Comprehensive incentive compensation package including an annual cash bonus, new hire equity, and an annual refresh.
• 401(k) match and Financial Planning tools.
• Competitive and inclusive medical, dental, and vision coverage options.
• Flexible Spending Accounts for medical and dependent care expenses.
• 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.
• Free premium access to fitness, nutrition, and mindfulness classes.
• Exclusive preferred pricing on Peloton fitness equipment.
• Dedicated care coordination support for our LGBTQ+ community.