Job Description

LabVantage LIMS Technical Manager – (Perm) – Hybrid (3 day/wk) – Santa Monica, CA

Pharmaceutical organization seeks a LabVantage LIMS Manager with technical hands-on expertise in Java and LabVantage v8.4 or higher. Ideal candidate will have 5 to 10 years working in this capacity along with a history working FDA, ISO 13485, and Medical Devices. Expertise in LabVantage processes like sample management, stability, batch release, and lab execution are also required. This individual will lead the management, configuration, and optimization of LIMS, while working closely with QA, QC, stability and other teams to ensure LIMS operational efficiency and compliance. The ideal candidate is someone who has some management and one with the ability to roll up sleeves and do the work alongside other team members. Opportunity offers competitive base compensation along with extremely competitive benefits.

Requirements

• Bachelor’s Degree in Science, Technology, or related areas.
• US Citizen or Green Card Holder Work Authorization.
• The ability to reside locally in Santa Monica or relocate to the area for a hybrid opportunity.
• 5 to 10 years in LabVantage version 8.4 or higher with hands-on Java development experience , a history working in FDA, ISO 13485 and Medical Devices.
• This individual should also have strong experience in quality management systems and regulatory compliance.
• A history in LabVantage processes within sample management, batch release, stability, and lab execution.
• AI experience is a plus as is LabVantage Certification.

Responsibilities

• Leading the management, configuration, and optimization of LIMS LabVantage v 8.7.
• Ensuring IT supports the business needs for LabVantage LIMS across R&D, QC, manufacturing, and clinical laboratories, while working closely with QA, QC, stability, and other teams regarding LIMS operations ensuring efficiency and compliance with industry regulations.
• Managing and delivering IT projects throughout organizational digital systems.
• Deploying Patch and releasing updates while working cross-functionally.
• Creating, revising, and approving SOPS and reports within GMP, FDA, EU, Global and ICH guidelines.
• Triaging and evaluating site change requests while assessing global impact and prioritizing accordingly.
• Assisting various sites in the identification of master data elements for LabVantage deployment.
• Ensuring LabVantage processes meet data integrity and GMP standards, while also promoting global process adoption.
• Collaborating with department managers to define and report KPIs for deployment progress.
• Performing advanced computer tasks to include technical LabVantage development.
• Leading high-stakes engagements with extreme coordination and rapid decision-making capabilities, involving systems and some AI.

Benefits

• Base compensation is ideally $140K, however, which will go a bit higher for the ideal candidate.
• 10% annual performance-based bonus that combines individual and organizational performance.
• 401K with employer match of up to $15,000.
• Full Health Benefits.
• 2 weeks PTO; 1 5-day winter shut-down; 1 5-day summer shut-down
• RSUs (detail TBD)

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