Director, Manufacturing Legal Counsel

Kyowa Kirin North America • Sanford, NC

4d • Hybrid

About The Position

Kyowa Kirin is a global specialty pharmaceutical company dedicated to enhancing patient lives. As the company expands its North American presence, it is constructing its first U.S. manufacturing facility in Sanford, North Carolina. This role is for a full-time, embedded attorney to support this significant initiative as it transitions from construction to full operational status. The Manufacturing Counsel will be a key member of the U.S. Legal Department, serving as the primary legal business partner for the Sanford manufacturing site. The role will focus on providing contracting and transactional support, and will be the initial point of legal contact for site leadership on regulatory, Human Resources, and operational matters. This position will offer day-to-day legal support, in close collaboration with Legal, Compliance, Quality, and other internal experts, for all Sanford-related contracting and specific regulatory and compliance issues. This includes activities associated with planning, construction, qualification, validation, regulatory submissions, and manufacturing operations. As an individual contributor, the Manufacturing Counsel will act as a trusted legal advisor, utilizing sound judgment, practical risk assessment, and a collaborative, solutions-oriented approach within a dynamic, scaling manufacturing environment.

Requirements

• 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.
• 4–8 years of legal experience, preferably including contracting and legal support for manufacturing, construction, or operations in a regulated industry.
• Law firm experience required.
• 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.
• 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.
• Advanced proficiency in MS Office Suite (Word, Excel, Outlook).
• 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.

Nice To Haves

• Life science experience preferred but not 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 using contracting management systems (e.g., intake, workflow, approvals, and execution) is a plus.
• 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.

Responsibilities

• Manage the contracting process for Sanford-related agreements, including review, negotiation, approval, and execution, utilizing the Legal Department’s contract management system.
• Partner with Sanford stakeholders to draft and negotiate manufacturing, construction, consulting, equipment, supply, and operations-related agreements.
• Prepare guidance and training materials to facilitate the efficient and compliant use of the Legal Department’s contract management system.
• Coordinate the work of paralegals and outside counsel supporting Sanford matters.
• Provide practical legal guidance on laws and regulations applicable to pharmaceutical manufacturing operations, including the Food, Drug, and Cosmetic Act.
• Partner with Legal colleagues and outside counsel to address complex legal matters affecting Sanford operations.
• Provide legal support to Human Resources on Sanford-related employment and employee relations matters, in coordination with internal and external counsel.
• Work closely with Legal and Compliance colleagues to ensure consistent and efficient guidance in accordance with Kyowa Kirin’s healthcare compliance policies and related laws and regulations.
• Conduct legal research and draft memoranda or provide counsel in response to Sanford-related legal and regulatory inquiries.
• Serve as a member of the Sanford site Senior Leadership Team and an embedded legal advisor to Sanford business partners.
• Engage regularly with Sanford site leadership and cross-functional stakeholders to ensure 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 requiring 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director