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The Manufacturing Counsel will be a member of the U.S. Kyowa Kirin Legal Department and serve as the primary legal business partner supporting the Sanford manufacturing site, with a focus on contracting and transactional support, while acting as the first point of legal contact for site leadership on regulatory, Human Resources, and operational matters. This role will provide day-to-day legal support-in close collaboration with Legal, Compliance, Quality, and other internal subject-matter experts-across Sanford-related contracting and selected regulatory and compliance matters, including activities related to planning, construction, qualification, validation, regulatory submissions, and manufacturing operations.

YEAR

Kyowa Kirin is a global specialty pharmaceutical company committed to improving the lives of patients. Kyowa Kirin, Inc., the U.S. operating entity, is expanding its North American footprint by building its first U.S. manufacturing facility in Sanford, North Carolina ("Sanford"), a greenfield site currently progressing through the construction phase. As the site moves toward start-up and future operations, we are seeking a full-time, embedded attorney to support this critical initiative as it scales from build-out to steady-state operations. Summary of Job: The Manufacturing Counsel will be a member of the U.S. Kyowa Kirin Legal Department and serve as the primary legal business partner supporting the Sanford manufacturing site, with a focus on contracting and transactional support, while acting as the first point of legal contact for site leadership on regulatory, Human Resources, and operational matters. This role will provide day-to-day legal support-in close collaboration with Legal, Compliance, Quality, and other internal subject-matter experts-across Sanford-related contracting and selected regulatory and compliance matters, including activities related to planning, construction, qualification, validation, regulatory submissions, and manufacturing operations. As an individual contributor, the Manufacturing Counsel will operate as a trusted legal advisor, applying sound judgment, practical risk assessment, and a collaborative, solutions-oriented approach in a fast-paced, scaling manufacturing environment. Reporting relationship: Senior Director, Senior Corporate Counsel (Princeton, NJ), with dotted-line reporting relationship to the Vice President of Manufacturing (Sanford, NC). Essential Functions: Contracting & Transactional Support (primary responsibility) • Utilize the Legal Department's contract management system to manage the contracting process for Sanford-related agreements, including review, negotiation, approval, and execution. • Partner with Sanford stakeholders to support the drafting and negotiation of manufacturing, construction, consulting, equipment, supply, and operations related agreements. • Prepare guidance and training materials to support the efficient and compliant use of the Legal Department's contract management system. • Coordinate the work of paralegals and outside counsel supporting Sanford matters, as needed. Regulatory & Human Resources Support • Provide practical legal guidance on laws and regulations applicable to pharmaceutical manufacturing operations, including the Food, Drug, and Cosmetic Act. Partner with Princeton-based Legal colleagues and outside counsel, as needed, to address more complex or significant legal matters affecting Sanford operations. • Provide legal support to Human Resources on Sanford-related employment and employee relations matters, in coordination with internal employment counsel and external counsel as appropriate. • Work closely with colleagues from Legal and Compliance to provide consistent and efficient guidance in accordance with Kyowa Kirin's healthcare compliance policies and related laws and regulations. • Conduct legal research and draft memoranda / provide counsel in response to Sanford-related legal and regulatory inquiries. Site Leadership & Strategic Cross-Functional Support • Serve as a member of the Sanford site Senior Leadership Team and an embedded legal advisor to Sanford business partners by applying sound judgment, practical risk assessment, and a solutions-oriented approach in a fast-paced manufacturing and site-startup environment. • Engage regularly with Sanford site leadership and cross-functional stakeholders to support alignment on contracting priorities, legal risk considerations, and compliance expectations. • Collaborate with internal functions to support cross-functional and cross-border Sanford initiatives. • Support Sanford-related projects and initiatives that require coordination across functions or regions to ensure alignment with Kyowa Kirin policies and Legal Department practices. • Develop strong working relationships across the organization and operate in alignment with Kyowa Kirin's global values: Commitment to Life; Innovation; Integrity; and Teamwork / Wa. Job Requirements: Education • BA/BS required. • Juris Doctorate degree from Accredited Law School is required. • Admission in good standing to at least one U.S. state bar; eligibility for North Carolina in-house registration required. Experience • 4-8 years of legal experience, preferably including contracting and legal support for manufacturing, construction, or operations in a regulated industry. Life science experience preferred but not required. • Law firm experience required. In-house experience is a plus. • Experience with cross-functional teams (including ex-US) and demonstrated ability to collaborate effectively with others to address complex legal, compliance, and operational issues is a plus. • Experience in drafting and negotiating contracts such as master services agreements, statements of work, confidentiality agreements, consulting agreements, master purchase agreements, supply agreements, quality/technical agreements, and other corporate pharmaceutical-related and/or manufacturing-related agreements is required. • Experience using contracting management systems (e.g., intake, workflow, approvals, and execution) is a plus. • Must understand contract law and have effective communication and negotiation skills and the ability to influence and work collaboratively at all levels and across functions. • Demonstrated understanding of pharmaceutical manufacturing operations and the related regulatory environment is a plus. • Foundational understanding of employment law or counsel human resources functions is a plus. • Experience supporting a start-up, greenfield, or rapidly scaling operational environment is a plus. Technical Skills Advanced proficiency in MS Office Suite (Word, Excel, Outlook). Non-Technical Skills Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Comfortable working onsite in a manufacturing and construction environment and engaging directly with operational stakeholders. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Physical Demands: The role will initially involve work in an office setting and on an active construction site in Sanford, North Carolina, with a planned transition in 2027 to the fully operational Sanford manufacturing facility. Working Conditions: Requires up to 10% domestic and limited international travel The anticipated salary for this position will be $227,300 to $270,000. 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: <ul><li>401K with company matching </li><li>Annual Bonus Program (Sales Bonus for Sales Jobs) </li><li>Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days </li><li>Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) </li><li>HSA & FSA Programs </li><li>Well-Being and Work/Life Programs </li><li>Long-Term Incentive Program (subject to job level and performance) </li><li>Life & Disability Insurance </li><li>Concierge Service </li><li>Pet Insurance </li><li>Tuition Assistance </li><li>Employee Referral Awards </li></ul> 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. 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 kkus.talentacquisition.8h@kyowakirin.com. Controller's data protection officer can be contacted at usprivacyoffice@kyowakirin.com. 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 usprivacyoffice@kyowakirin.com. 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. #LI-JC1

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Director, Manufacturing Legal Counsel Kyowa Kirin North America

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