QC Specialist III LIMS and Operational Support

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 .

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.

The Role:

The QC Specialist III LIMS and Operational Support will be responsible for providing System Administration/Master Data support for the QC LIMS application. This role will support the ongoing operations and maintenance lifecycle of LIMS usage and act as the primary interface between QC and IT for LIMS. This role will work closely with both the site LIMS business lead and the IT LIMS technical lead. In addition, this role will be responsible for supporting the implementation and management of other QC tools, such as LIMS interface with ERP, LIMS printers, bar code readers, Empower and Lab X software.

Responsibilities:

• Collaborate with: QC laboratory users to define master data requirements for ongoing LIMS operational usage and provide solutions for continuous improvement enhancements in compliance and efficiency: QC Lab stakeholders to help translate the business requirements into technical solutions in LIMS; cross-functional groups (QA, Validation, IT, etc.) to help to develop user requirements and configuration documents and manage vendor IQ/OQ of equipment.

• Support and maintain LIMS configuration documentation and plan for new product, equipment, and workflows; assist with the requirements definition for other QC systems, such as LIMS interface with ERP, data servers, bar code readers, and electronic laboratory notebooks.

• Assist in managing the operations of LIMS in a validated environment and help develop policies and procedures related to compliance requirements, users with queries, reports, and tracking/trending of QC lab data; the first line of troubleshooting for LIMS issues for QC users.

• Develop, revise, and review SOPs, protocols and reports and other documents to support QC equipment, LIMS and other computerized systems; provide computerized system and LIMS training to new users and grant system access.

• Perform business administration activities for other QC Lab software such as the Empower chromatography system and the LabX system which supports lab instruments like balances, pH meters and conductivity meters; lab compliance with applicable cGMP regulations and SOPs, and support both internal and external audits; Initiate and project manage change controls for QC lab computer systems.

• Collect and report, track and maintain metrics for QC systems/equipment and QC users; create new and update current methods and specifications in LIMS.

• Provide guidance and training to junior colleagues and oversee training activities for groups; support end users and provide guidance in the implementation of new LIMS functionality.

• Troubleshoot issues, solve problems, and assist with investigations and deviations.

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

Quantitative Dimensions:

The QC Specialist III LIMS and Operational Support will be the SME and provide support in ensuring equipment, systems, and operations remain in compliance, while delivering continuous improvement enhancements.

Organizational Context:

The QC Specialist III LIMS and Operational Support will typically report to the Manager or Sr Manager Quality Control. 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 5+ years or M.S. degree with 3+ years of relevant experience in working with analytical computerized systems.

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

• Experience using LIMS as an end user (e.g., QC Analyst performing data entry in LIMS).

• Experience as a System Administrator for QC Laboratory computer systems (including LIMS, Empower). Includes experience with configuring and testing LIMS master data.

• Expertise in regulations governing data integrity and computerized systems.

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

• Experience with MasterControl or other EDMS (Electronic Data Management System).

• 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.

• 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 with a focus on quality and attention to details.

• Highly self-motivated and goal oriented.

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

• Works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned.

Preferred:

• 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 environment. Includes commercial-off-the-shelf (COTS) lab computer systems.

• Experience conducting data integrity (DI) assessments and the associated DI remediation activities.

• Experience serving as a change agent and driving continuous improvement and automation across QC.

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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

#LI-TD

Category Sanford TC

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

EOE including Disability/Protected Veterans