Associate Director, Manufacturing Science and Technology

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. Santen USA, headquartered in Emeryville, Calif., is an important part of our worldwide efforts and is home to our regional business teams. We have about 350 total employees in North America, including our other offices located in Toronto, Canada, Fort Worth, TX and Miami, FL. For more, visit https://www.santenusa.com/.

The Associate Director, Manufacturing Science and Technology (MSAT) reports to the Head of External Manufacturing and Sourcing (EM&S) for Santen North America. In this role, you would be responsible for technical support activities for commercialized products, project management of technology transfer projects, analytical & pharmaceutical support activities, and technical investigations/root cause analysis for products manufactured at CMOs, in a cGMP environment. 

You will work cross functionally with the business having specific focus on late stage clinical and commercial stage products as well as an awareness of future R&D programs. You will manage complex situations and challenge the status quo, through collaborative effort and with hands-on activities when necessary, with good balance of strategic thinking and tactical approach, and prioritize tasks within our dynamic business and market environment.

ESSENTIAL RESPONSIBILITIES: 

• Timely management and execution of Technical Transfer projects, for existing product transfers and new product launches, including responsibility for core project management activities
• Critical thinking and problem-solving support of the Quality and Regulatory departments by providing technical resolution of manufacturing based CMO quality issues
• Support of legal contract negotiation, particularly Technical Transfer Agreements and the technical elements of the Manufacturing & Supply Agreements
• Provide input on Quality Agreements with external partners, as necessary
• Provide due diligence evaluation and advice on external manufacturing business opportunities in partnership with the Business Development team
• Drives consistency and high-quality input and support to the RA team to ensure regulatory dossiers are prepared and compliant with Health Authority regulations and guidances
• Ensures and facilitates communication among management, peers and associates; proactively communicate critical situations in an adequate and timely manner to interdisciplinary teams and to appropriate management level in RA, QA, Supply Chain and R&D as appropriate
• Liaises with all relevant groups to ensure high quality technical documentation is developed
• Collaborates with the business on potential lifecycle management opportunities in formulation and process development
• Perform other duties as necessary as assigned by management
• Travel: up to 10 to 20%, domestic U.S.

• Seven (7) to ten (10) years of experience in either formulation, manufacturing or process development related to the development of sterile-fill pharmaceuticals, with a minimum of six (6) years in Chemistry, Manufacturing and Control (CMC) technical experience preferred
• Significant experience with drug development processes and cGMP drug product supply requirements for sterile product manufacturing
• Proven experience in Project Management, preferably in Life Cycle Management (Launches, Transfers, Product discontinuation, etc.), as well as process improvements in cross functional and international teams working in different time-zones; PMP certification desired
• Familiarity with MHLW, EMA or APAC GMP requirements is a plus excellence in influencing people, negotiation and communication skills as well as potential for excellence in leadership
• Proven project management leadership, ideally with experience in managing Technical Transfers to CMOs
• Ability to coach and develop people and teams and to recruit to support the talent pipeline
• Excellent working knowledge/experience in regulatory submission and approval processes and proven practical knowledge of and ability to resolve complex manufacturing based regulatory issues
• Proven track record of successfully leading teams, planning, coordinating and leading activities simultaneously on multiple projects
• Regularly demonstrated active contributions to line functions or project teams
• Respected leader within department and/or other line functions
• Demonstrated leadership in risk assessment and mitigation, strategic thinking, maintaining awareness of business impact
• Demonstrated ability for innovative and big picture thinking
• Strong interpersonal, organizational, communication, presentation, negotiation and problem-solving skills
• Computer literacy (e.g. MS Project, PowerPoint, document management systems) available and shown ability to quickly learn new software, tracking tools and associated processes

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.

COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19. Individuals who choose not to get vaccinated and who receive a job offer must follow Santen’s process for requesting a medical or religious exemption and subsequent accommodation. Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.

For more information about our company and the work experience, please visit https://www.santenusa.com/career-culture.