QC LIMS Administrator
Bridgewater, NJ
Quality – Quality /
Full Time /
On-site
We are seeking an innovative and detail-oriented QC LIMS Administrator who contribute significantly to the development of our advanced cell therapy manufacturing platform.
This individual will be responsible for supporting the Laboratory Information Management System (LIMS) within the Quality department by configuring, maintaining, and improving master data and templates used throughout the Global LIMS system. The ideal candidate will serve as a subject matter expert (SME) to develop/build master data such as: parameters, parameter lists, test methods, batch data, products, specifications, sample plans, production batch records and product specifications.
Additionally, this role is responsible for report design and collaboration with stakeholders on improvement and efficiency initiatives such as implementation of QC workflows as well as lab instrument interfacing. The LIMS administrator will provide user support and develop and deliver training as well as provide support for system enhancements by processing change controls, gathering requirements, and writing/executing test scripts. The ideal candidate will demonstrate effective teamwork by developing strong relationships with internal stakeholders, peers, and management through effective oral and written communication in a GMP environment and is ensuring the site is operating per cGMP and regulatory data integrity requirements.
Candidates should be highly motivated, capable of independent work, enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
- Developing, leading, organizing and managing the LabVantage in a cGMP environment for the Cellares QC laboratories
- Interact with QA, IT and QC to ensure data flows are compliant within the LIMS system
- Ensure seamless functional integration with other Cellares developed and out-of the box software systems
- Maintaining and developing a robust LIMS system in a cGMP environment with the other LIMS functional roles and LIMS super users
- Provide support for resolving LIMS problems in close collaboration with Cellares stakeholders while in operation
- Improve Cellares QC laboratories efficiency by bringing manual workflows into LIMS and assisting in the integration of LIMS into other lab management systems and equipment
- Handle sampling plan, specification, COA/COT template creation, generation and revisions appropriately
- Assist in creating LIMS templates of trending reports for raw materials testing, Finished Product testing and Environmental Monitoring
- Support and maintain documentation for user manuals, validation documentation and training manuals
- Onboard and offboard new users in LIMS and provide general training and workshops for end users to ensure correct system utilization
- Collaborate with IT and QA to coordinate system upgrades, patches and migrations while minimizing disruptions to laboratory operations
- Participate in regulatory inspection readiness activities and support responses related to LIMS during audits
- Support existing ELN modules for legacy LIMS as needed
Requirements
- BA or B.S. degree in Computer Science, Information Technology, Laboratory Science or related field
- 5+ years of experience in cGMP or cGxP
- Prior experience working with LIMS administration, configuration and development
- Experience with LabVantage is a plus
- Experience with initial development and roll out of LIMS LabVantage system is a plus
- Experience with autologous cell therapy label testing is a plus
- Experience with regulatory (e.g. IND/BLA) filings and GMP inspection is a plus
- Ability to work independently as well as in a team-oriented environment
- With effective time management skills
- Detail oriented with strong analytical and problem solving skills
- Proven logic and decision-making abilities, critical thinking skills
- Expected to keep up to date on regulatory changes for data integrity, US FDA 21 CFR Part 11 and EU Annex 11
- Must have excellent verbal, written, interpersonal, and organizational and communication skills
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
$90,000 - $210,000 a year
Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
