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. 

Purpose of Role

1. To manage and enable successful commercial production and ensure the stable product supply of EMEA manufactured products, including driving technical investigations & root cause analysis at CMOs.  Responsible and accountable for the successful technical functioning of CMOs.
2. To take part in Tech Transfer Projects for both existing EMEA products and New Product Introductions (NPIs), ensuring continuity of supply for existing products and timely new launches. 
3. This position contributes for commercial product support activities including cross-functional cooperation and interactions with the CMOs. 

1. Responsible for the transfer of the manufacturing method/process: providing the CMO the manufacturing method details, product specification, CQAs/CPPs/critical material information. Compiling the TT protocols and reports in cooperation with CMO.
2. Compile regulatory documentation on manufacturing process and primary packaging materials for the variations (Module 3 documents, Module 2/quality overall summaries)
3. Responsible for the process and filter validations of the transferred manufacturing processes
4. Deviations:  supporting or leading the manufacturing process related deviation evaluations as agreed with QA. Evaluating the manufacturing process part (statements) and/or leading the investigation: assembling the expert team and leading both internal and external meetings to find out the root cause. Evaluate, report and provide small scale project management.
5. Change Control: management of manufacturing process changes including change control management; opening the change controls in Track Wise and collecting all requirements for the change from the experts. Discuss and align with CMOs on the change. Compile the regulatory documents for the variation, if needed. Manage process validations where required.
6. Update critical process and material details list (Control strategy document, document indicating critical steps and material in the process), providing the changed CQAs/CPPs for CMOs
7. Santen CMO capabilities:  maintain information on manufacturing equipment & CMO expertise.
8. Validations:  ensure the validity of the processes; review the on-going process verification protocols, lead the possible new process validations.  Maintain validation of the sterilizing filters; organizing the filter validation with the filter vendor
9. Technical Transfers: contribute for the process transfers according to the Global Tech Transfer Project (GTTP) process.

1. University graduate in pharmacy/medical/life sciences
2. At least 3 years of experience working in the Pharmaceutical and/or Medical Device industry
3. An overall understanding of GMP requirements and knowledge in the manufacturing of sterile products
4. Able to operate and communicate both internally and externally. Ability to work with individuals at all levels.
5. Working in a matrix environment.
6. Experience in the product support and/or technology transfers
7. Cross-functional and cross-cultural working ability.
8. Self-starter, motivated and self-driven.  
9. Challenges the status quo with a view to continuous improvement 
10. Results focused; high level of energy and motivation for achieving the final objective/results
11. Ability to work independently and prioritize work to achieve results with minimal instruction. 
12. Excellent writing, editing and computer skills including MS Office (Word, PowerPoint, Excel, Vision and, if possible, MS Project).

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.

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