Director, Manufacturing

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 translate science into smiles by delivering therapies 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, North Carolina, and Mississauga, Ontario.

The Director, Manufacturing will lead the KKNA North Carolina Manufacturing Operations and be a member of the Site Leadership Team (SLT). The Director will ensure Operational Readiness for the facility start up in 2027; and deliver the Production Plan of Record subsequently as the project moves from construction, commissioning, and start up into routine operations.

This role reports into the VP, Site Leader NA Manufacturing.

• Ensures all work is carried out safely and in accordance with all applicable regulations, policies and procedures for a regulated DS manufacturing facility.
• As a member of the SLT, is mutually accountable for the Site Performance including delivery of site Strategies, Goals, Metrics and Reports. In addition, as an SLT member the Director is also mutually accountable for all aspects of Talent Management including acquisition, development, retention, recognition and performance management.
• Leads Operational Readiness for Manufacturing in the project phase.
• Business Systems Owner for digital systems, ensuring delivery of all systems in accordance with program plans.
• Leads Operational Excellence for the site.
• Leads the Tech Transfer function, including MS&T.
• Works collaboratively with other KK manufacturing sites including Takasaki (key site) and associated CDMOs.
• Develops and delivers operating budgets per corporate guidance.
• Performs other related duties as assigned.

BS degree in Life Sciences, Chemical or Industrial Engineering, Pharmaceutical Sciences or associated technical field.

• At least 10 years of experience in Bio Pharma Manufacturing in a leadership role.
• Front line supervisory experience in Pharma ops.
• Experience in Technical Transfer and / or Methods Transfer.
• Experience in managing a Manufacturing Operation’s budget.
• Involved in Bio Pharma Industry Organizations to understand current practices and trends in Bio Pharma.

• Knowledgeable in Bio Pharma Manufacturing Operations and Technical Operations Leadership.
• Strong knowledge of Safety and Sustainability Practices.
• Operational Excellence experience in LEAN and Agile manufacturing techniques.
• Bio Pharma business systems working knowledge including: QMS, MES, PCS, ERP, LIMs, and other standard systems used in Bio Pharma manufacturing.
• Cost accounting background.
• Technical Process Transfer and Methods Transfer understanding.
• Regulatory Compliance working knowledge.

• Leads as a role model of our Kabegoe Principles, KK Values and Leadership Behaviors. Leads with integrity and respect for all. Values and promotes diversity.
• Builds strong Teams and grows Leaders. Manages Talent effectively.
• Strong communicator and collaborator.
• Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced environment. Has a passion for personal learning and development to be able to grow with the company.
  
  Cultural sensitivity and ability to develop consensus within a multinational organization.

Initially working in an office setting and construction site and ultimately in a biotech manufacturing site in Sanford, NC.

Work is 100% on-site. This is not a hybrid or remote role.

Requires up to 20% domestic and international travel.

The anticipated salary for this position will $185,800 to $242,600
. The actual salary offered for this role…