NCBiotech
Senior IT Systems Specialist - LIMS and Lab Applications
NCBiotech, Princeton, New Jersey, us, 08543
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 5 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
The anticipated salary for this position will be $83,700 to $108,800. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job‑based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
401K with company matching
Discretionary Profit Sharing
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes a Summer and Winter Shut‑Down, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
HSA & FSA Programs
Well‑Being and Work/Life Programs
Life & Disability Insurance
Concierge Service
Pet Insurance
Tuition Assistance
Employee Referral Awards
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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.
Recruitment & Staffing Agencies 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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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 5 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
The anticipated salary for this position will be $83,700 to $108,800. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job‑based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
401K with company matching
Discretionary Profit Sharing
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes a Summer and Winter Shut‑Down, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
HSA & FSA Programs
Well‑Being and Work/Life Programs
Life & Disability Insurance
Concierge Service
Pet Insurance
Tuition Assistance
Employee Referral Awards
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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.
Recruitment & Staffing Agencies 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.
#J-18808-Ljbffr