The Manager, Technical Services will be responsible for various activities under the direction of the Director of Sterile Dosage Technologies. These include performing process development/scale-up studies, participating in the manufacture of cGMP clinical lots, and transfer of processes to clinical or commercial manufacturing facilities for new drug candidates or existing commercial products. Experience with biologic and combination products regulations and development (including Human Factor Studies) is a plus.
- Participates in and oversees the drug development process of selected drug products (sterile and biologic) and API, ensuring robust and compliant manufacturing processes
- Evaluates and optimized manufacturing processes using appropriate statistical analysis, root-cause-analysis, and quality-by-design principles.
- Requires extensive skills and experiences in process development and optimization through scale-up studies and transfer of processes to clinical or commercial manufacturing facilities at Contract Manufacturing Operation (CMO).
- Requires experimental skills in applying Statistical Design of Experiments (DOEs) and Quality by Design (QbD) to existing unit operations of pharmaceutical finishing processes.
- Oversees development of various drug products and manufacturing activities that are performed by vendors and contractors and provides technical assistance during manufacturing.
- Assists with the development of deparmental project timelines and project plans.
- Coordinates regular technical review and project planning meetings with relevant CMC and supply chain functions, including frequent update meetings with OPC-J
- Ensures that contract manufacturers meet Otsuka requirements during development phases.
- Responsible for the design and development of division and departmental Standard Operating Procedure
- Provides any technical, product, and/or manufacturing related training regarding the sterile drug product to other Otsuka employees as deemed appropriate by management and organization.
- B.S., M.S., or Ph.D. Pharmacy, Chemistry or Engineering + 4-8 years pharmaceutical development and manufacturing experience
- Ability to work with and lead a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals.
- Thorough knowledge of pharmaceutical development to early stage drug product manufacturing, sterile product manufacturing, and new process technology
- Thorough knowledge of cGMP's and GLP's
- Experience with Microsoft Word, Excel, PowerPoint and Project
- Excellent interpersonal and communication skills
- Ability to operate in a multi-cultural, multifaceted corporate environment
- Be task & detail oriented
- Experience in sterile and biologic drug product process development and manufacturing
- Experience in scale-up and transfer of API manufacturing process
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com
OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/