Associate Director, Biologics Drug Substance

COMPANY DESCRIPTION

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:Modality Innovation 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 provides global support in developing products outside of the U.S.

PRIMARY PURPOSE OF POSITION

This position is responsible for Drug Substance development for Santen's Biologics. The person will be responsible for 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:

• Identify and establish contracts and relationships with CDMOs developing stable cell line and upstream and downstream development of drug substance, and effectively manage the drug substance development activities in alignment with drug product and clinical development activities
• 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 clinical manufacturing activities
• 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/BLA
• Develop and manage 3-way relationships with multiple vendors, such that processes and optimal solutions are provided in successful product manufacturing
• Maintains project specific budget and provides input to department budgets

KNOWLEDGE AND SKILL REQUIREMENTS:

• Minimum B.S. Degree in Chemical Engineering or Biochemistry with minimum of 8-10 years relevant experience, or a PhD in Biochemistry/Chemical Engineering/Pharmaceutical Sciences with a minimum of 3-5 years of relevant experience
• Hands on experience of biologic drug substance (mAbs/ fusion proteins/ nanobodies) development, with thorough knowledge on upstream and downstream purification and strong understanding of analytics
• Experience in managing Contract Development / Manufacturing Organizations is essential
• Experience and/or knowledge in stem cell and/or viral vector manufacturing is a plus
• 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 regulatory guidelines
• Ability to effectively operate in an environment that requires collaboration, influencing skills, negotiation skills, and analytical judgment
• Excellent written/oral communication and presentation skills
• Strong analytical skills and attention to detail