Manufacturing Director jobs in Cary, NC

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 areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey, North Carolina and California) that focus on drug discovery, product development, manufacturing and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

Summary:

The Director of Manufacturing will lead the KKNA North Carolina Manufacturing operations, ensuring safe, effective, efficient and timely manufacturing of products in accordance with all applicable laws, regulations, policies and procedures.  

Essential Functions:

•    Talent Management including: recruitment, hiring, training and development of manufacturing employees.
•    Executes Performance management processes
•    Builds and delivers the production plan in accordance with all applicable regulations and standards.   
•    Handles discipline and termination of employees as needed and in accordance with company policy.
•    Implements and monitors production tools and systems to ensure safety, quality and timely delivery of products in accordance with established budgets and production plans.  
•    Ensures a healthy and safe working environment, in compliance with federal and state and local regulations, through collaboration with all stakeholders- internal and external. 
•    Implements effective training programs for staff to build and improve skills.
•    Develop operating budget and performance metrics.
•    Liaises with Takasaki, Japan site to align on standards and for Tech Transfer. 

Requirements:

Education
Bachelor’s degree in a technical field required; Formal Training in Safety and OpEx is strongly preferred.  

Experience
At least 10 years of experience in BioPharm Manufacturing in a hands-on role.  Supervisory experience in Pharma ops is a must. Experience with Tech Transfer is a plus.   

Technical Skills
Knowledgeable in Safety, Regulatory Compliance, Audit, Biological Manufacturing, risk analysis, capital planning, production IT systems (ERP, MES, PCS, Change Control, Lock out-Tag out, etc.).   

Non-Technical Skills
As a member of the Site Leadership Team, develop and execute strategies and goals for the site. The Manufacturing Director will also collaborate closely with all site functions and influence peers and their goals.  Ability to build and lead a team to execute the production plan.  Ability to implement Operational Excellence Practices and systems to monitor and improve performance.  Ability to develop production plans and budgets. 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.

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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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