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
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.
Manufacturing Operations managers, MS&T manager, Operational Excellence Lead, plus dotted line reports for Digital systems.
Education
BS degree in Life Sciences, Chemical or Industrial Engineering, Pharmaceutical Sciences or associated technical field.
Experience
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.
Technical Skills
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.
Non-Technical Skills
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 be $185,800 to $242,600. 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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What We Do
Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. We work on some of the hardest to treat diseases where need is high, and potential for life-changing impact is possible.
The North America organization includes three offices in New Jersey and California that focus on drug discovery, product development, and commercialization. Together, we work as a collaborative team to understand clinical needs and advance innovations that have a profound impact on patient lives.
Our growth in North America relies on entrepreneurial team players who are willing to share their expertise and ideas in an environment that prioritizes innovation, diversity, integrity and “wa.” Each person plays a significant role in shaping the work we do and the results we deliver.
