Associate Director, Pharmaceutical Development
Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 3,500 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA, contributes important ophthalmic research and development efforts worldwide and is home to our regional business teams. This office currently employs about 140 people and will grow by 50%+ in the near future.
With the passionate support of our Japanese parent company and its 125-year heritage, Santen is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.
We are driven by and committed to our mission: Delivering Vision, Every Day. Additionally, our Corporate Strategy Policy for FY18-FY20 has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.
We are in search of top talent to help us meet our aggressive and important goals.
DEPARTMENT DESCRIPTION:Pharmaceutical Development Operations is one of the essential functions within Santen Inc.'s Research and Development group. The Research & Development group is responsible for developing and obtaining marketing approval for products in the U.S. and also provides global support in developing products outside of the U.S.
PRIMARY PURPOSE OF POSITION
This position is responsible for Pharmaceutical Development activities such as outsource management of manufacturing and testing activities, technology transfer from internal to external development/manufacturing organizations and coordination and management of activities that feed into regulatory submissions.
MAJOR DUTIES OF POSITION:
- Manage development of primary packaging such as prefilled syringes and other container closures and associated ancillary supplies such as syringes and needles with outside vendors
- Manage technology transfer activities, develop packaging configurations and serve as CMC lead from Pharmaceutical Development on Functional Device projects, such as Glaucoma Devices
- Coordinate development, manufacturing and testing activities with Contract Manufacturing Organizations and Testing Labs. Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects
- Perform development and validation activities, author protocols and reports, and collaborate with External Manufacturing function in securing the commercial manufacturing activities
- Collaborate with Advanced Technology Operations in identifying and managing CMOs that can manufacture early stage clinical supplies for Santen's drug delivery systems
- Collaborate with External Manufacturing function in identifying and performing tech transfer to alternate CMOs for products that are in late stage
- Author relevant sections of IND/NDA/PMAs
- Develop and manage 3-way relationships with multiple vendors, such that processes and optimal solutions are provided in successful product and device manufacturing
- Performs functional activities of clinical supplies and project management activities from a clinical supplies perspective
- Maintains project specific budget and provides input to department budgets
KNOWLEDGE AND SKILL REQUIREMENTS:
- Minimum B.S. Degree in scientific discipline; Masters' Degree or MBA is a plus.
- Minimum 8 - 10 years of relevant experience in Pharmaceutical Development & Manufacturing, good understanding of material science, device development nuances, and guidelines associated with pharmaceutical product and device development with good Project Management skills
- Strong ability to strategically plan, organize, and manage multiple projects simultaneously
- Demonstrated track record of creativity and problem solving in projects
- Ability to work in interdisciplinary teams with strong interpersonal skills
- Strong knowledge of relevant GxPs, as well as, applicable multinational regulations
For more information about our company and the work experience, please visit www.santenusa.com