Description:

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