Jobs at Kyowa Kirin
419 open positions
Senior Director, Program Management – Patient Services
Company: Kyowa Kirin
Location: Princeton-Trenton
Posted Apr 30, 2024
Kyowa Kirin is seeking a Senior Director, Program Management – Patient Services to lead the strategic direction and oversight of North American Patient Services. The role involves developing and implementing strategic initiatives to enhance patient services, leading a diverse team, overseeing vendors, ensuring ethical patient data management, and creating service offerings. The ideal candidate should have a Bachelor's degree in healthcare or related field, at least 10 years of progressive experience in Patient Services/Access, and expert knowledge of Patient Support Programs. Proficiency in MS Office Suite, CRM platforms, and Channel Data Aggregation is required. The role involves up to 15% domestic and international travel.
Associate Director, CQV Lead
Company: Kyowa Kirin
Location: Princeton-Trenton
Posted Mar 13, 2024
<p><strong>Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies stateoftheart biotechnologies to discover and deliver novel medicines in four areas of unmet need oncology nephrology immunology and CNSmovement 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 closeknit team to understand clinical needs and advance innovations that can have a profound impact on patient lives<strong><p> <p><strong>Summary<strong><p> <p><strong>The CQV Lead will lead the Commissioning Qualification and Verification of the NC Manufacturing Facility The CQV Lead will also be responsible for developing and implementing the Operational Readiness Program to enable safe timely and compliant production of Drug Substance by 2027 <strong><br ><strong>Post project implementation the CQV Lead will be responsible for CQV activities at the site as it transitions into routine operations <strong><p> <p><strong>Essential Functions<strong><p> <p><strong> Provide CampQ input to design development as part of the KKNA project team<strong><br ><strong> Selection of and management of thirdparty CampQ and Operational Readiness service providers<strong><br ><strong> Planning and coordination of CampQ activities with third party provider in line with current industry best practice and riskbased approach ISPE ASTM E2500<strong><br ><strong> With CampQ service provider track progress in line with agreed schedules to enable delivery of overall program including from a safety and compliance perspective<strong><br ><strong> Planning and coordination of Operational Readiness activities with third party provider in line with current industry best practice<strong><br ><strong> Alignment of Operational Readiness outputs with overall facility startup plan to deliver an aligned and seamless executionready state<strong><p> <p><strong>Requirements<strong><p> <p><em>Education<em><br >Bachelors degree in a technical field required Formal GMP and Safety training is essential <p> <p><em>Experience<em><br >At least 10 years of experience in CQV for BioPharma Manufacturing or Capital Projects Leadership experience in CQV and Operational Readiness is a must Experience with Tech Transfer is a plus Background in cGMP regulations GAMP EHS permitting is required <p> <p><em>Technical Skills<em><br >Knowledgeable in cGMPs GAMP Safety Practices Regulatory Compliance Protocol Development and Execution Risk Assessment Criticality Assessment and System TurnoverTraining <p> <p>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<p> <p>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<p> <p>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 kkustalentacquisition8hkyowakirincom Controllers data protection officer can be contacted at <u>usprivacyofficekyowakirincom<u> Your personal data will be processed for the purposes of managing Controllers 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 61f of General Data Protection Regulation EU 2016679 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 <p> <p>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 Controllers 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<p> <p>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<u> usprivacyofficekyowakirincom<u><p> <p><b><strong>Recruitment amp Staffing Agencies<strong><b> <p><p>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<p> <p>LITT1 Sanford Carolina<p>
2025 Summer Internship - Manufacturing
Company: Kyowa Kirin
Location: Raleigh-Durham, NC
Posted Sep 09, 2024
Kyowa Kirin is a global pharmaceutical company seeking a summer intern to join their team. The intern will work on meaningful activities and contribute to the design and construction of a biologics manufacturing facility.
2025 Summer Internship - Legal and Compliance
Company: Kyowa Kirin
Location: Princeton-Trenton
Posted Sep 06, 2024
Kyowa Kirin is a pharmaceutical company seeking a law student to join their Legal and Compliance Department. The internship involves working closely with the Legal and Compliance teams on various projects, including contract management, legal research, and compliance training.
Director, Plant Operations IT Head
Company: Kyowa Kirin
Location: Princeton-Trenton
Posted Mar 08, 2024
Kyowa Kirin is seeking a Manufacturing Site IT Leader with at least 10 years of experience in manufacturing plant and supply chain operations, including 6+ years in Cloud Computing. The role involves overseeing IT operations at a new state-of-the-art facility, managing IT systems and infrastructure, driving digital transformation initiatives, and leading a team of IT professionals. The IT Head will also develop and implement IT policies, ensure compliance with regulatory requirements, and collaborate with global manufacturing IT teams. The ideal candidate should have a Bachelor's degree in Information Technology, relevant certifications, and strong understanding of GMP regulations and pharmaceutical quality systems.
2025 Summer Internship - Translational Research
Company: Kyowa Kirin
Location: Princeton-Trenton
Posted Sep 04, 2024
Kyowa Kirin is a global pharmaceutical company that is looking for talented students to participate in a paid internship in their Transitional Research department. The internship involves analyzing genomic data and collaborating with colleagues in the US and Japan.
Associated Director, Commercial Analytics
Company: Kyowa Kirin
Location: Princeton-Trenton
Posted Mar 18, 2024
The job description is for an Associate Director, Commercial Analytics, who will support the Kyowa Kirin, North America franchise teams in providing business insights and holistic solutions to help steer strategic direction and improve execution efficiency. The role requires strong analytical, conceptual, and problem-solving abilities, as well as excellent communication and presentation skills.
Associate Director of Procurement, Commercial Operations and Strategy
Company: Kyowa Kirin
Location: Princeton-Trenton
Posted Apr 03, 2024
Kyowa Kirin North America is seeking an Associate Director of Procurement, Commercial Operations and Strategy. This role involves developing and implementing procurement strategies aligned with commercial and corporate objectives, managing the KKNA Small Business Subcontracting Program, leading a team of NA Procurement Analysts, and fostering strong relationships with key suppliers. The ideal candidate will have a Bachelor's degree in a relevant field, at least 7 years of pharmaceutical procurement experience, and strong leadership, business acumen, communication, adaptability, and cultural competence skills. The role requires up to 10% domestic and international travel and a commitment to sustainability and diversity in procurement practices.
2025 Summer Internship - Supply Chain Systems and Planning
Company: Kyowa Kirin
Location: Princeton-Trenton
Posted Sep 04, 2024
Kyowa Kirin is a pharmaceutical company seeking a student intern to join their team. The intern will work on meaningful activities, contribute to the company's digitization strategy, and gain experience in supply chain management.
2024 Summer Intern - Legal
Company: Kyowa Kirin
Location: Princeton-Trenton
Posted May 01, 2024
Kyowa Kirin is seeking a law student for a paid, temporary internship in their legal department. The intern will work closely with the legal team, supporting various business functions and assisting with tasks such as implementing an electronic contracts management system, conducting legal research, and helping to create a culture of compliance. The role is hybrid, requiring in-office time and a commitment from May 28th to August 9th. KKNA offers an excellent company culture with opportunities for learning and growth, and is committed to equal employment opportunities.
Regulatory Affairs Compliance and Planning- Project Manager
Company: Kyowa Kirin
Location: Princeton-Trenton
Posted Apr 17, 2024
<p>Kyowa Kirin is a fastgrowing global specialty pharmaceutical company that applies stateoftheart biotechnologies to discover and deliver novel medicines in four disease areas bone and mineral intractable hematologic hematology oncology and rare disease A Japanbased company our goal is to make people smile by delivering breakthroughs 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 Massachusetts and Ontario<p> <p><strong>Summary<strong><p> <p>The Project Manager Global Regulatory Affairs Compliance and Planning will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget <br >This individual will support the develop of performance metrics and tracking mechanisms for timely monitoring and reporting of project performance<p> <p><strong>Essential Functions<strong><p> <p>The Project Manager Regulatory Affairs Global Compliance and Planning is responsible for driving implementation of and adherence to best practices in project management<p> <p> This role will be a regional NA lead for Global Compliance and Planning and is responsible for ensuring global compliance and planning initiatives are implemented locally when applicable <br > Manage or support projects within the Global Compliance and Planning function and other appropriate project management initiatives within GRA<br > Close partnership between global and regional regulatory functions as well as cross functional stakeholders such as QA PV and IT <br > Partner with GRA Compliance and Planning team members to deliver on the strategy of achieving industry leadership process efficiency standardization and ingraining a cultural mindset of continuous improvement<br > Lead the project planning process and ensure strategic business objectives are met by the most efficient use of budget and resources <br > Lead GRA risk management tracking initiatives <br > Support regulatory inspection readiness and regulatory audit inquiries<br > Collaborate with Compliance and Planning team in the conduct of SOP and work instruction GAP analysis to ensure aligned global and regional processes <br > Develop performance metrics and conduct timely monitoring and reporting of project performance<br > Responsible for driving excellence in the execution of project role out and training <p> <p><strong>Requirements<strong><p> <p><em>Education<em><br >Bachelors degree PMP Certified Prior experience in Life sciences industry Pharmaceutical Medical Device or BioTech is beneficial but not required<p> <p><em>Experience<em><br >5 years of pharmaceutical experience Broad understanding of pharmaceutical development Regulatory Affairs Quality Assurance Safety and Commercial Experience <br >managing crossfunctional teams in a global business<br >environment is required Experience implementing change management is also an important experience for this role <p> <p><em>Technical Skills<em><br >Proficient in MS Office Suite eg Microsoft Project Powerpoint Excel<p> <p>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<p> <p>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<p> <p>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 kkustalentacquisition8hkyowakirincom Controllers data protection officer can be contacted at <u>usprivacyofficekyowakirincom<u> Your personal data will be processed for the purposes of managing Controllers 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 61f of General Data Protection Regulation EU 2016679 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 <p> <p>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 Controllers 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<p> <p>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<u> usprivacyofficekyowakirincom<u><p> <p><b><strong>Recruitment amp Staffing Agencies<strong><b> <p><p>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<p> <p>LITT1 Hybrid<p>
Sr. Manager, Quality Control
Company: Kyowa Kirin
Location: Orlando, FL
Posted Sep 03, 2024
The Sr Manager Quality Control will play a critical role in designing and executing the operational readiness program for the Quality Control laboratories at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. The role will involve providing technical leadership, collaborating cross-functionally, and ensuring compliance with current GxP Standards and with all applicable Global, Regional, and Site procedures within Kyowa Kirin's Quality Management System.