Director, Manufacturing jobs in United States
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Kyowa Kirin, Inc.- U.S. · 5 hours ago

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. The Director, Manufacturing will lead the North Carolina Manufacturing Operations and ensure Operational Readiness for the facility start-up in 2027, while delivering the Production Plan of Record.

Pharmaceuticals
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

BioPharma Manufacturing OperationsTechnical Operations LeadershipOperational ExcellenceTechnical TransferSafetySustainability PracticesBioPharma business systemsCost accountingRegulatory ComplianceLeadership BehaviorsTeam BuildingCommunicatorCultural sensitivityInterpersonal skillsDetail oriented

Required

BS degree in Life Sciences, Chemical or Industrial Engineering, Pharmaceutical Sciences or associated technical field
At least 10 years of experience in BioPharma 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 BioPharma Industry Organizations to understand current practices and trends in BioPharma
Knowledgeable in BioPharma Manufacturing Operations and Technical Operations Leadership
Strong knowledge of Safety and Sustainability Practices
Operational Excellence experience in LEAN and Agile manufacturing techniques
BioPharma business systems working knowledge including: QMS, MES, PCS, ERP, LIMs, and other standard systems used in BioPharma 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

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

Company

Kyowa Kirin, Inc.- U.S.

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Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.

H1B Sponsorship

Kyowa Kirin, Inc.- U.S. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
2021 (1)

Funding

Current Stage
Late Stage

Leadership Team

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Ana Bastiani-Posner, MBA
Executive Vice President & Chief Financial Officer
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Tara D'Orsi
Executive Vice President, Chief Compliance Officer and General Counsel at Kyowa Kirin North America
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Company data provided by crunchbase