ICT Business Technical Specialist QC, LIMS

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

As a Business Technical Specialist, you will lead the North America & North Carolina manufacturing site ICT team in configuration, implementation, deployment and operational support of manufacturing site's QC IT applications (i.e. LIMS, ELN & Other Lab Instrument Software and System / Instrument Integrations). Your responsibilities will include supporting SDLC/ GxP validation activities related to implementation and change controls of QC IT software systems / integrations. Provide functional / technical expertise on system features, system functionality, access/security controls, master data and understanding of the business processes. This role will act as a System Administrator as needed (set up new users and manage security roles), coordinate the needs of QC functional areas and lead LIMS configurations for key business processes in LIMS system related to compliance processes, instrument calibration, quality operations, environment monitoring, CoA, stability testing, vendor compliance, manage inventory, design of queries and report, develop product sampling/test plan.

This role reports into the Director, ICT, Site Lead

* Expertise in LIMS application processes, specifically LabVantage
* Proficiency in LIMS interfacing, navigation, and customization to streamline workflows and enhance user experience
* Experience in leading projects to conclusion, making recommendations for improved outcomes.
* Strong understanding and application of ITIL processes and best practices, with the ability to independently drive continuous improvement initiatives
* Experience with ITSM tools and frameworks, leveraging them to optimize service delivery and align IT support with business needs
* Demonstrated independence in diagnosing and resolving complex technical issues, applying sound judgment and critical thinking to identify root causes and implement effective solutions.
* In-depth knowledge of troubleshooting methodologies and the ability to proactively address and mitigate recurring technical challenges
* Extensive experience with system administration tasks, including advanced configuration, performance tuning, and optimization to support business-critical applications
* Strong understanding of security best practices, risk management, and compliance standards, ensuring robust protection of business assets and data
* Excellent communication and interpersonal skills, with a focus on high-level business partnership and aligning IT support with organizational goals
* Ability to manage complex customer inquiries and provide tailored, high-quality solutions that enhance employee experience and business performance
* Advanced capability in creating and maintaining detailed technical documentation, ensuring knowledge sharing and alignment across teams
* Experience in generating, analyzing, and presenting actionable technical reports to senior leadership, contributing to strategic decision-making
* High level of customer service focus, consistently fostering positive employee and business partner relationships, and ensuring a seamless IT experience for all end users

Education
Associate's or Bachelor's degree in Information Technology, Computer Science, or a related field.

Experience
At least 3 years of hands-on IT support experience, including troubleshooting complex issues, system management, and working directly with end-users and business partners; Experience in IT Project Management; Proven ability to thrive in ambiguous, fast-paced environments; possess a strategic mindset and Experience with GMP, GDP, and biopharma manufacturing facilities is a plus.

Technical Skills
Proficient in MS Office Suite.

Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.
Normal office environment with prolonged sitting and extensive computer work.

Work is 100% on-site. This is not a hybrid or remote role.

Requires up to 10% domestic and international travel

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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