LIMS Principle System Administrator

4 days ago

Westborough, United States Astellas Pharma Full time

Principle System Administrator

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Principal System Administrator opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Principle System Administrator will be responsible for defining the requirements for implementation of software systems and managing the requirements for the ongoing operations as the primary interface between Operations and IT. Some examples of this would be user management, master data configuration and role management. Primary platforms will be LIMS and EBR applications. In addition, they will be responsible for supporting data integrity efforts at the site to ensure compliance to 21CFR Part 11 for manufacturing and lab equipment.

Essential Job Responsibilities:

  • Develop and maintain system configuration documentation and plan for new product, equipment, and workflows. Provide first line of troubleshooting issues for users.

  • Manage the operations of systems in a validated environment and develop policies and procedures related to compliance requirements; Work with end users to develop user requirements and configuration documents and manage vendor IQ/OQ of equipment.

  • Develop, revise, and review SOPs, protocols and reports and other documents to support equipment, platforms, and other computerized systems.

  • Develop and provide computerized system training to new users and grant system access and ensure lab compliance with applicable cGMP regulations and SOPs, and support both internal and external audits; Collect and report metrics.

  • Manage system updates, change controls and maintenance activities as relating to systems.

  • Troubleshoot issues, solve problems, and assist with investigations and deviations related to software systems.

  • Create/manage master data to support existing/new system functionalities.

  • Ensures that the integrity and accuracy of all documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.

Quantitative Dimensions:

The Principle System Administrator will be accountable for defining the requirements for implementation and management digital systems and managing the requirements for the ongoing operations. This role will work closely with the IT technical lead.

Organizational Context:

The Principle System Administrator will typically report to the Associate Director, Manufacturing Technical Support. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

Qualifications Required:

  • B.S. degree in biological sciences, cell biology, chemistry, or related field with 7+ years or M.S. degree with 5+ years of relevant experience in working with analytical computerized systems.

  • Prior laboratory hands-on experience with a variety of analytical computerized systems.

  • Expertise in regulations governing data integrity and computerized systems.

  • Experience in qualification of analytical equipment, including those with computerized systems.

  • Experience with electronic document management systems.

  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment.

  • Strong knowledge of GMP, SOPs and quality control processes.

  • Strong knowledge of quality systems and regulatory requirements.

  • Experience and knowledge in implementation and management of LIMS.

  • Experience in translating laboratory user requirements to IT implementations.

  • Experience with Windows OS, domains, networks and basic computing infrastructure in lab/production environment.

  • Good to excellent technical writing skills and verbal communication skills.

  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion.

  • Highly self-motivated and goal oriented.

  • Will support and demonstrate quality standards to ensure data of highest quality.

Preferred:

  • Experience in a small company and high growth, fast-paced environment.

  • Experience working with additional electronic laboratory systems such as ERP, BMRAM, Empower, LabX.

  • Experience with instrument integration/direct data capture from stand-alone COTS systems to LIMS application.

Working Conditions:

  • This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.

  • This is an on-site role working in a cGMP regulated manufacturing facility.

  • On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%).

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

#LI-TD

Category Massachusetts TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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