Kyowa Kirin - Sanford, NC
posted 16 days ago
About the position
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 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. The Senior Manager, Manufacturing Sciences and Technology (MS&T) will play a critical role in providing strategic direction and technical leadership for development, characterization, technical transfer, manufacturing and testing of clinical and commercial drug substance and drug product. The position requires a deep understanding of manufacturing processes and analytical methods to ensure monitoring, troubleshooting and continuous improvement at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. This role will be involved in the transfer of Phase II, III and early commercial drug substance manufacturing from other Kyowa Kirin sites or Contract Manufacturing Organizations (CMOs). Working with internal and external teams to develop robust processes for manufacturing. This leader will possess a deep understanding of mAb drug substance manufacturing process and analytical methods to lead the transfer efforts for new and existing products. As a people leader, you will embody compassionate, people-centric leadership to guide and support our team. You will collaborate closely with others, fostering a collaborative, inclusive, and supportive environment while driving team development. Your work will reflect the organization's values and integrity in all your actions. Utilizing situational leadership and emotional intelligence, you will align diverse viewpoints, manage stakeholders, and make empathetic decisions to address individual and team needs effectively. You will also be results-oriented, ensuring that your team not only adapts to challenges but also delivers measurable outcomes that align with business objectives. Additionally, you will help teams navigate through change and uncertainty with resilience and clarity, enabling them to adapt to fast-evolving, rapidly scaling environments and meet new challenges in the biotech industry with a patient-focused mindset.
Responsibilities
- Providing technical knowledge, oversight and leadership for the development, characterization, and commercialization of mAb drug substances
- Leading the transfer of drug substance processes to and from the manufacturing facility and evaluating and optimizing processes to improve efficiency and quality
- Supporting investigation and troubleshooting following deviation related to manufacturing process and equipment
- Performing impact assessment and collaborating with QA and MFG on establishment and execution of change action plan
- Hiring, training, and developing a team of engineers and scientists
- Working with other departments, such as manufacturing, QA, QC, Supply chain, and process engineering to ensure processes are maintained and transferred effectively
- Authoring and reviewing technical reports, process transfer summaries and other documents
- Ensuring that changes to processes and methods are documented and carried out in compliance with cGMP requirements
- Communicating project status to internal customers and suppliers
Requirements
- MS or PhD in Pharmaceutical Sciences, Physical Sciences, Engineering or related Life Sciences is required. PhD preferred
- Minimum 5 years of experience in Manufacturing, Science, and Technology within the Pharmaceutical industry
- Experience with Tech Transfer and Analytical Method Validation
- Demonstrated project management skills
- Demonstrated leadership and teamwork skills
- Excellent analytical and communication abilities
- Deep understanding of process validation concepts and experience with technical transfer in a GMP environment preferred
- Proficient in MS Office Suite, statistics and designed experiments
Nice-to-haves
- Experience with mAb drug substance transfer
