Manager, LIMS

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

This position is responsible for supporting the Laboratory Information Management System (LIMS) within the Quality Assurance unit by configuring, maintaining, and improving master data and templates used throughout the LIMS System for the Eisai Exton site as well as providing cross site support. 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 paperless workflows as well as lab instrument interfacing. The Manager, 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. The ideal candidate will also possess the ability and skill set to support other Quality Assurance applications.

Essential Functions

The LIMS Manager will serve as the site coordinator, administrator, and SME for LIMS and provide necessary training to staff, lead cross-functional project teams and work with stakeholders to determine and translate business requirements into technology solutions as well as assist with other quality systems such as TrackWise and Veeva. This includes responsibility for planning, directing, and coordinating project activities from initiation through implementation as well as system upgrades. Responsible for providing ongoing system support including creating and/or running reports or queries associated with the system.

• LIMS:

  • Create and/or run various periodic ad hoc reports/queries.

  • Execute IQ/OQ/PQ documents as required to maintain system for existing and new applications.

  • Train users according to assigned roles.

  • Provide ongoing system support and administration.

  • Prepare and provide documentation as required for internal and regulatory agency audits and maintain copies of reviewed documents.

  • Create or revise SOPs as required.

  • Troubleshoot any unexpected issues or errors that arise.

Requirements

Education and Experience

• Bachelor's degree (preferably in science related discipline, IT or Business Management) preferred.

• 5+ years of experience working with Quality Systems IT applications specifically with SAP, Veeva and LIMS administration.

• Training within a regulated Pharmaceutical/biotech/medical device environment.

• Understanding and application of cGMP's (EP, JP, USP).

• Experience with regulatory inspections and serving as the SME for quality systems.

• Detailed knowledge and application with electronic Quality Systems and Data Integrity.

Technical

• Strong attention to detail as demonstrated through consistent quality of work.

• Excellent written and verbal communication skills.

• Computer proficiency in MS Word and Excel, MS Access required.

• Demonstrates process orientation-thinks through required steps and sequencing to ensure quality work output.

• Ability to anticipate potential problems and take proactive action to avoid/minimize impact. Function as change agent to ensure accurate and timely facilitation of global and department, GMP, etc. changes.

• Anticipates consequences of actions and how they impact other areas.

• Ability to utilize project management skills to independently prioritize, plan and schedule workflow.

• Timely follow up to ensure satisfactory resolution to issues.

• Knowledge of CGMPs (relevant laws, guidance, directives, and industry practice), and demonstrated ability to apply learnings appropriately in a controlled environment.

• Ability to interpret and apply GMPs, relevant laws, guidance's, and directives to extremely complex pharmaceutical situations.

• Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency.

• Ability to work collaboratively with internal and external team members and customers/contacts.

• Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance.

• Role requires a full-time presence at the Exton site.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Right To Work