Director, Manufacturing Legal Counsel

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 startup and future operations we are seeking a fulltime embedded attorney to support this critical initiative as it scales from buildout to steadystate 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 daytoday legal supportin close collaboration with Legal Compliance Quality and other internal subjectmatter expertsacross Sanfordrelated 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 solutionsoriented approach in a fastpaced 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 Departments contract management system to manage the contracting process for Sanford-relatedagreements 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 Departments 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 Kirins 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 solutionsoriented approach in a fastpaced manufacturing and sitestartup environment.
Engage regularly with Sanford site leadership and crossfunctional stakeholders to support alignment on contracting priorities legal risk considerations and compliance expectations.
Collaborate with internal functions to support crossfunctional and crossborder Sanford initiatives.
Support Sanfordrelated 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 Kirins 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
48 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 -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 startup 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 $227300 to $270000. 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
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs Sick Days and Volunteer Days
• Healthcare Benefits (Medical Dental Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• 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.

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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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