Associate Director, Manufacturing Project and Product Management

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 and California) that focus on drug discovery, product development, 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.

As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.

Summary of Job

The CMC Project and Product Management (P&PM) Associate Director will be responsible for the integration, creation and execution of multiple CMC development strategy and plans. This position will report to the Executive Vice President, Region head of NA/EU Manufacturing and will work closely with head of P&PM (Project and Product management) Group and Global CMC lead in Japan and the other region CMC lead as well as cross-functional CMC related teams to support CMC activities.

In this role, the Region CMC P&PM Associate Director will

• Assure the timely completion of CMC tasks for multiple assigned projects.
• Lead regional CMC related teams and works closely with related departments in all other regions through global CMC lead network.
• Cooperate with the relevant functions to direct the preparation and delivery of the drug substance and drug product of development products as required.
• Manage related budget preparation for submission and approval.
• Share and report on the activity status of each product team in a timely manner so that Global CMC lead will be able to centrally manage the project and the product while coordinating the activities globally.
• Change and modify the strategies and plans in collaboration with Global CMC lead as necessary to improve the situation while monitoring the progress of CMC plans in the region.
• Resolve issues quickly and mitigate the project and product related risks by close collaboration and timely decision making among region functions.

Essential Functions

• Develop and create global regulatory CMC strategies for multiple clinical development projects at all stages (Phase I through post-approval), with a focus on innovation, maximizing the business benefit balanced with regulatory compliance.
• Lead the preparation for, and conduct of, formal CMC meetings with regulatory health authorities including the review of applications and negotiations with Health Authorities.
• Provide regulatory support to other Kyowa Kirin functions / CMO’s during Regulatory Authority inspections.
• Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing risks and benefits.
• Plan, prepare, and critically review CMC components of regulatory documents including INDs, Annual Reports/DSURs, Amendments, Comparability Protocols, Evaluation Packages, MAAs, BLAs, NDAs, DMFs, Meeting Briefing Packages, SPA, IBs, and equivalent documents of other countries’ health authorities without supervision.
• Respond in a timely manner to deficiency questions and inquiries from health authorities. Collaborate with project team representatives to ensure those documents meet regulatory requirements
• Assists the head of P&PM (Project and Product Management) Group and proposes mid- to long-term strategies and directions related to product development, production, and supply in line with the mid- to long-term strategies of the CMC Development Dept.
• Leads CMG-related multi-function team including SCM/Procurement/Tech/Mfg./etc. in region and actively supports product on CMC activities associated with Life Cycle Planning and Management in alignment with product LCM strategy.
• Shares information about CMC plans, projects and product with region CMC teams in a timely manner while cooperating closely with Global CMC lead.
• Provides leadership to support CMC project teams or multi­ function project teams for multiple assigned products while supporting global CMC leads.
• Supports global CMC leads for annual budgeting and budget progress monitoring.
• Performs budget management for assigned regions and products and executes business within the budget of the P&PM Group.
• Supports reduction of total costs 
• Assists the head of P&PM Group in the work related to the proper allocation of budget related to product development, manufacturing, and supply of the Production.
• Collaborates with related departments on the development of a medium-term plan for building an efficient global CTM supply system.
• Supports an efficient global supply plan for clinical trial materials (CTMs).
• Supports the CMC regulatory activities such as IND/ IMPD, application preparation, CTD submission / inquiry response, and dossier maintenance in the region, including authority consultations.
• Assists the head of P&PM Group to discover and organize global issues related to product development, production, and supply, and promote solutions.
• Coordinates with related departments to deal with various issues of each product (complaint handling, change management, deviation management, manufacturing site change, etc.).
• Assists the head of P&PM Group in the overall management and operation of the project & product management group and the realization of continuous and smooth transition of product development, production and supply operations.
• Develops CMC plan for new products and initial production schedule in cooperation with related departments, and coordinates prompt and reliable approval and early stable production support.
• Participates in global investigational drug manufacturing planning based on new product development plans; and collaborates with related departments in the supply chain.
• Participates in company-wide LCM development planning for additional indications or applications and dosage forms, implements CMG-related early approval strategies, and collaborates on early launch response.
• As Owner of Change Control for the CMG related changes derived from the region, initiates the change control, coordinates the change implementation in the region and reports the progress to the Global CMG Lead.
• At the R&D Committee/ Development Advisory Committee meeting of the developed product in charge, summarizes the CMG plan, progress, and risk assessment from the perspective of the production division (CMG part) and submits to the Project Lead.
• Leads the related department team to evaluate and plan the optimal production site and capital investment based on the production strategy of developed and commercial products.
• Summarize evaluations from a technical and manufacturing perspective in due diligence.
• Ensures company intellectual property is maintained by scrutinizing external disclosure permission and internal information linkage as management of intellectual property of the Manufacturing Division.

Job Requirements

• This position requires a minimum of an M.S. or Ph.D. in Pharmacy, Pharmaceutics, life sciences, biological sciences or Biotech/Chemistry plus at least 7 years of experiences in the pharmaceutical development of investigational drug candidates is required. A BS in Pharmacy or Chemistry with additional relevant experience (14-18 years) can be considered.
• Experience with multiple aspect of the manufacturing process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (oral solids, parenteral, topicals) is required.
• Experience in the management of other technical personnel (4-8 people) is required.
• Previous experience in the preparation and negotiation of development or commercial agreements focusing on the pharmaceutical industry is required.
• Experience of CMC related change control in pharmaceutical for multi-countries is strongly a plus.
• Experience with various dosage forms and scale- up/commercial pharmaceutical manufacturing processes and equipment is desired.
• Experience along all aspects of the manufacturing/supply process for biologics (cell culture, drug substance, drug product), small molecule, transdermal patch, secondary packaging, and cold chain distribution is ideal.
• Experience working with CDMOs, vendors and suppliers and maintaining successful partnerships. Experience with submissions/filings for NA and EU.
• Excellent communication and project management skills are required as this position is responsible for the scientific evaluation and coordination of work performed by external organizations.
• The ability to manage multiple projects ant to work well within a team environment is also essential.
• An advanced understanding of GMP/GLP/GCP requirements and FDNICH and the other CMC related guidelines is required.

Technical Skills

Proficient in MS Office Suite

Non-Technical Skills

Highly motivated and great attention to detail. Strong endurance to work under tight timelines and complex/changing situations. Excellent business and strategic acumen - and ability to manage expanding levels of complexity. Excellent scalability of skills­ has been "big manager" and can support growth in scope to support Kyowa Kirin hyper-growth in next several years. Can design/implement processes and then run process to deliver.

Excellent communication skills and executive presence - verbally and in writing. Strong influencing skills, as demonstrated in a matrixed environment. Strong leadership skills - both in a small/growing environment and in a large/established environment. Strong international experience - especially Japanese culture. 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.

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