Analyst, Serialization Operations

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.

Summary of Job:

The Serialization Operations Analyst is a key technical role responsible for ensuring consistent high performance and reliability of the serialization systems and processes. The role requires a strong focus on driving quality into operations and continuous improvement. This role involves improving data quality, implementing best practices, and integrating data standards to ensure compliance with drug distribution supply chain regulatory requirements. This individual will be part of a fast-paced team seeking to comply with an evolving landscape of serialization regulations and leveraging new capabilities to improve the way Kyowa Kirin makes and delivers products to patients. This individual will interact with a wide range of business functions to manage transactions, resolve transactional errors, understand processes, improve capabilities, and deploy new technologies quickly and effectively.

Essential Functions:

Role responsibilities:

• Responsible for ensuring high data quality and accuracy of the serialization data reported by the plant manufacturing systems.
• Ensure compliance with all aspects of DSCSA and other global regulatory requirements.
• Serve as EPCIS data expert responsible for reading, understanding, and troubleshooting EPCIS data reported by various business systems involved in the business process.
• Ensure compliance with full traceability of units, cartons, cases, and pallets from manufacturing through delivery to the customer.
• Monitor Data quality of DSCSA and other regulatory data processed by the Serialization Systems.
• Document Issues, ensure analysis is completed, root cause analyzed, and resolutions are implemented promptly and consistently with an aim for Continuous improvement.
• Ensure the Serialization system is maintained concurrently with the latest systems capabilities through additional processes, system upgrades, etc.
• Support testing and validation of the serialization systems.
• This role will be accountable for responding to verification requests of data scans ensuring that verification requests are legitimate.
• Proactively monitor the systems daily to avoid delaying product release to market.
• Maintain procedures and compliance with serialization regulations in a timely fashion.
• Assist in investigating and verifying negative responses to salable return verification requests.
• Strictly adhere to relevant regulatory and compliance guidelines and company policies
• Kyowa Kirin reserves the right to change or modify such duties as required.

Job Requirements:

Education

Bachelor’s Degree or equivalent, preferably in Engineering or Science discipline. 

Experience

3+ years of experience supporting Serialization business processes. Life sciences/Biotech or similarly regulated environment experience required. Experience with Good Manufacturing Practice and Good Documentation Practice. Business Excellence training (such as Six Sigma) is preferred, but not required.

Technical Capabilities

Technical training in Serialization Systems such as Optel’s Verify Brand, TraceLink, SAP ATTP, etc. Experience with ERP (Microsoft Dynamics 365 preferred, but not required). Well-versed with Serialization Data standards from GS1 and familiarity with the implementation of these standards by various Serialization Systems. Demonstrable skills in data analysis and problem-solving.

Non-Technical Skills

Interpersonal & communication skills. Ability to manage through complexity in a matrixed business environment. Ability to influence a broad stakeholder group. Action-oriented. Desire to be part of a High-Performing Team.

Physical Demands:

Normal office environment with prolonged sitting and extensive computer work

Working Conditions:

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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

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 [email protected].

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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