Manager, QC LIMS

FUJIFILM Holdings America Corporation; Holly Springs (MS); On-site; USD 80,000 - 130,000; Full time

Job summary

An established industry player is seeking a dynamic Manager for their QC Laboratory Information Management System. This pivotal role involves leading a team of LIMS experts to implement a global system that enhances laboratory operations and drives efficiency. You will be responsible for strategic planning, user requirements, and system design, ensuring compliance with quality standards. Join a forward-thinking company dedicated to biopharmaceutical innovation, where your expertise will contribute to the next breakthroughs in healthcare. If you are passionate about making a difference and thrive in a collaborative environment, this is the perfect opportunity for you.

Qualifications

• 7+ years in GMP environments with LIMS experience in pharmaceuticals.
• People management experience and full life cycle LIMS implementation.

Responsibilities

• Lead the LIMS team to enhance lab operations and efficiency.
• Manage project budgets and ensure data integrity in LIMS.

Skills

Leadership

Project Management

Data Integrity Principles

GMP Knowledge

LIMS Expertise

Communication Skills

Education

Bachelor's Degree

Master's Degree

PhD

Tools

LabWare v8

Job description

Position Overview

The Manager, QC Laboratory Information Management System (LIMS) is responsible for developing strategic plans for implementing FDB's global Laboratory Information Management System (LIMS). This role harmonizes processes across all current and future FDB sites and leads the transition of QC into a paperless environment. The Manager, QC LIMS guides a team of LIMS experts to translate global and site-specific needs into user requirements, system design, configuration, and implementation plans. This role acts as the primary subject matter expert (SME) for LIMS and focuses on maintaining and continuously enhancing the global LIMS system.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description

What You'll Do

• Provides cross-functional leadership as the recognized LIMS expert
• Develops strategic implementation plans, recruits LIMS staff, and manages project budgets
• Ensures data integrity principles are at the core of LIMS implementation
• Directs the LIMS team to:

1. Establish user requirements and best practices to enhance laboratory operations, reduce cycle times, and boost efficiency
2. Identify and assess opportunities for improving the LIMS implementation process
3. Develop, implement, and review validation protocols, SOPs, test scripts, and training materials for LIMS
4. Configure, customize, maintain, and upgrade the LIMS system
5. Develop Master Data templates for LIMS
6. Provide support and training to new users for data entry and reporting

• Manages and prioritizes the workload and responsibilities of the LIMS team
• Provides guidance and support to less experienced team members
• Identifies and implements system improvements
• Integrates quality and regulatory compliance into LIMS design
• Prepares and delivers presentations to both internal and external stakeholders
• Manages and develops direct reports from LIMS team
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Performs other duties, as assigned.

Minimum Requirements:

• Bachelor’s degree with 7+ years of experience in a GMP environment and LIMS experience in pharmaceutical industry OR
• Master’s degree with 5+ years of experience in a GMP environment and LIMS experience in pharmaceutical industry OR
• PHD with 3+ years of experience in a GMP environment and LIMS experience in pharmaceutical industry

• 2-5 years of people management experience
• Proven experience in full life cycle implementation of multi-site LIMS
• Proven experience in connecting analyzers to the LIMS and ability to provide a roadmap from Development to QC.
• Extensive knowledge of GMPs, computer system software development and validation, with the ability to apply to non-routine situations.
• Deep understanding and command of LIMS requirements.

Preferred Requirements:

• Experience in LabWare v8

Physical and Work Environment Requirements:

• Ability to discern audible cues.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time up to 120 minutes
• Ability to sit for prolonged periods of time up to 120 minutes
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).