Director, Manufacturing & Technology 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.

The Director, Manufacturing & Technology Management will be responsible for day-to-day technical support of Drug Substance/Drug Product/Final Packaging of Biologics/Small Molecule, and/or other products. This position will work closely with CDMO Management resources to ensure high performance, other M&TM Groups as well as cross-functional CMC related teams to support CMC activities.

In this role, the person will:

• Ensure that commercial manufacturing processes of multiple assigned products are robust, scalable and well-controlled to achieve stable and reliable supply for patients
• Be responsible for technical oversight and support for manufacturing and technical life-cycle management at region/global CMOs by utilizing a geographical advantage
• Lead the region technology transfer team or support the global joint-tech transfer team to launch successfully initial commercial site and/or additional manufacturing sites on schedule
• Lead to stabilize manufacturing operations and to continuously conduct Kaizen activities on production technology through cooperation and communication with CMOs
• Provide technical support to resolve deviation/Out-Of-Specification quickly and mitigate the manufacturing and technology related risks through close collaboration with Technical SMEs and timely decision making among regional functions
• Leads or supports the on-time execution of technology transfer projects to the regional or global CMO
• Ensures technical processing/packaging operations consistently meet all quality requirements
• Conducts manufacturing observation and executes PIP (Person In Plant) in CMOs
• Provides technical assistance to review deviation / CAPA report and Master Batch Records by closely working with Tech SMEs, Quality Assurance, and other relevant stake holders
• Supports manufacturing process robustness, equipment / facility maintenance, product technical life cycle management
• Provides technical support at CMOs with Tech SMEs, CMC-RA and QA on any regulatory audits and inspections
• Leads or supports negotiation and contracting on supply agreement with CMOs for development manufacturing
• Conducts manufacturing schedule management, manufacturing slot negotiation, Purchase Order / Letter of Intention management when needed
• Leads or supports shipment of Raw materials / DS / DP / samples and import / export control
• Performs technical troubleshooting and technical risk management on DS / DP / Final packaging sites
• Provides technical assistance for CMC-related team activities at each region including Change Control, GMP inspections, preparation of technical documents for IND/NDA/BLA, Authority observations
• Leads regular/ad-hoc technical review meeting with CMOs to discuss process stabilization, yield improvement, product quality enhancement and technical/process Kaizen plan with a close collaboration with Tech SMEs
• Provides technical support/evaluation for CMO / CRO selection and Due Diligence activities
• Strengthens strategically business partnership with CMO / CRO

Education

MS or Ph.D. in Pharmacy Pharmaceutics, life sciences, biological sciences, or biotech/Chemistry.

Experience

• At least 7 years (Ph.D.) or 14 years (Bachelors) experience in pharma development
• Experience with multiple aspects of manufacturing process development efforts, analytical characterizations, process scale-ups, and/or regulatory registrations of Drug Substance, Drug Product is required
• Experience in management of technical teams (4-8 members). Global teams is a plus.
• Experience in preparation and negotiation of development or commercial agreements focused on pharmaceuticals
• Experience in CMC related Change Controls in Pharma for multiple countries/regions is a plus
• Experience with multiple dosage forms and scale-up, commercial manufacturing processes and equipment
• Experience along all aspects of the manufacturing/supply process for biologics, small molecule, transdermal, secondary packaging, cold chain is ideal
• Experience working effectively with CDMOs, vendors, supplies – building and maintaining successful partnerships
• Experience with NA, EU, and global filings/submissions
• Excellent communication skills and project management skills
• Ability to manage multiple projects and to work well within a team environment
• Advanced understanding of GMP/GLP/GCP requirements and FDAICH and other CMC related guidelines

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/strategic acumen – and ability to manage expanding levels of complexity.  Excellent scalability os skills – ability to support expected growth in company and project load.  Can design/implement processes – AND run processes effectively, delivering strong performance. 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 with Japanese culture.  Broad level of interpersonal skills and flexibility.  Cultural sensitivity and ability to develop consensus within a multinational organization.

Requires up to 25% domestic and international travel. 

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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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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