[Japan] Product Technical Specialist

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.

Core Mission This is a department that, from a production technology perspective, works to launch new pharmaceutical manufacturing on factory lines, while also engaging in stable product manufacturing and quality improvement to realize the stable supply of Santen products to patients worldwide. You will design manufacturing methods and control methods to enable the new manufacturing of pharmaceuticals on factory lines, perform technology transfer in collaboration with factory personnel, and contribute with leadership to the continuous stable manufacturing and quality improvement of products.

Job Description Core roles of the position (Production Technology role: understanding, utilizing, and applying pharmaceutical manufacturing and control methods): ・Deepen understanding of the formulation characteristics, manufacturing methods, and control methods of development products and finished products, and proactively and actively acquire this knowledge to utilize in operations. ・Collect and design technology transfer information for manufacturing methods with high success probability through the creation and execution of plans for lab experiments and pilot-scale production, and contribute to the creation of advanced technology transfer documents. ・Evaluate CMO manufacturing technology and manufacturing lines, consider product manufacturing conditions, aim to improve the success probability of technology transfer, and take charge of proposing reinforcement and improvements such as manufacturing equipment improvements in collaboration with the engineering department. ・Exercise leadership to ensure that technology transfer operations (internal and CMO) are promoted in a state that meets QCD and regulatory requirements while collaborating with factory departments. ・Contribute to the design of validity for product manufacturing control, quality control, and change management, as well as to improvement and enhancement, through risk assessments for product quality improvement and discussions with factory personnel. ・Support the deployment, continuous maintenance, and sale of products in markets around the world through the creation of regulatory submission documents and responding to inquiries.

<Required Experience/Skills> ・Practical experience in formulation development or production technology (manufacturing method design, technology transfer, etc.) (3+ years) ・Practical experience in Equipment Qualification or Process Validation (3+ years) ・Ability to read English documents and English email communication skills ・Basic knowledge of relevant regulations such as GMP and pharmaceutical laws

<Ideal Candidate Profile> ・Ability to judge problems accurately and objectively, communicate one's own opinions appropriately to third parties, possess cooperativeness, and communicate smoothly with related departments. ・An attitude of taking ownership to solve problems on-site as necessary regarding product transfers to multiple domestic and international manufacturing sites or manufacturing challenges.

<Preferred Conditions> ・Practical experience with sterile formulations or ophthalmic solutions ・Knowledge and experience in Quality by Design ・English proficiency (conversational level) ・Experience in coordinating and promoting team operations

(Scope of changes in job description) All company operations

(Scope of changes in work location) Head office and business offices/sales offices nationwide