Director, EM&S (External Mfg & Sourcing), North America

Location
Emeryville, CA, United States
Posted
Jul 26, 2021
Ref
1075
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION:

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

We are in search of top talent to help us meet our important goals and large growth plans.

ABOUT THE POSITION:

As a key partner to the business, the Director of External Manufacturing and Sourcing (EM&S) is responsible for the strategic planning and execution of EM&S operations within North America (NA). This includes partner selection and 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.

This position will lead the external manufacturing, sourcing and CMO management for all Santen products and key strategic materials developed through joint development and/or licensing projects with external partners including those related to new business development opportunities for the NA market, developing and implementing the required organization, standards, processes, and procedures under the direction of the Head of Global EM&S.

Under the direction of the Head of Global EM&S, this position will represent the Global EM&S mission and share and co-own the regional business goals with other stakeholders. Under the guidance of the Santen’s Head of NA (Inc, CEO), this role is expected to actualize regional business goals within his/her EM&S responsibilities.

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Develops and executes the regional EM&S strategic and tactical plans in partnership with global EM&S and other internal/external related parties.
  • Develops the vision for EM&S, with direct accountability for external manufacturing operations and post launch technical support of all commercial products within the region, closely working with related functional leaders to support achieving North American business objectives.
  • Develops and executes the strategy, in conjunction with R&D and the Global Product Supply Department for commercial stage external partners including site selection and strategy for commercialization, evaluation of prospective partners for manufacturing/packaging capabilities and fit with the Santen organization.
  • Builds a quality ethos into all decisions and processes, reinforcing the implementation of Santen’s Global Tech Transfer Process (GTTP) standards to support Make-or-Buy decisions, Supplier Selection, Technology Transfers and the Management of Commercial Products.
  • Negotiates and runs RFPs to ensure the continuity of Global Product Supply requirements and delivers timely project management and execution of Technical Transfer projects, for existing and new product launches.
  • Manages external partner relationships and external manufacturing and sourcing in a cost-efficient manner, leading cross-functional business review meetings and developing relevant KPI’s that can be used as a platform to continuously improve supply from external manufacturers.
  • Provides due diligence evaluation and advice on external manufacturing business opportunities in partnership with the Business Development team.
  • Owns and controls the regional EM&S budget including capital investments with external partners, technical transfer expenses and laboratory costs.
  • Champions cross-functional working with departments such as Quality, Regulatory, Supply Chain, Business Development, Finance, Legal, R&D, and Marketing - in a multi-cultural, matrix organization, to ensure optimal supplier relationship management and the delivery of products to meet the needs of the business.
  • By critical thinking and problem solving, supports particularly the Quality and Regulatory departments by providing technical solutions for CMO quality issues and enabling timely and successful product launches.
  • Responsible for developing the EM&S organization within the region, and the subsequent management, talent development and mentoring of the team, ensuring the department is structured in an optimal way to meet evolving business needs.
  • Drives change management and continuous improvement of EM&S, implementing PDCA cycle and other continuous improvement (CI) principles.
  • Negotiates and executes legal contracts, together with the Legal and Business Development teams, including Manufacturing & Supply Agreements and Technical Transfer Agreements, structuring such contracts in an optimal manner so as to ensure the security of long-term supply and the protection of the Santen business.
  • Provides input on Quality Agreements with external partners as necessary.
  • Performs other duties as necessary as assigned by management.

QUALIFICATIONS:
  • BS Degree in Life Sciences such as Biotechnology or relevant degree required.
  • Post-graduate management training preferred (e.g. MBA, Finance training, etc.).
  • Minimum of ten years-experience in product supply and manufacturing management in the Pharmaceutical industry (Medical Device industry experience is a plus) with experience in new product launches.
  • Experience with aseptically manufactured products
  • Strong understanding of Supply Chain Management requirements
  • Strong experience in leading and managing external manufacturing / supplier networks (robust successful experiences in managing CMOs) in North America.
  • Solid management experience of the drug development process and drug product supply under cGMP requirements for sterile product manufacturing. Familiarity with MHLW, EMA or APAC GMP requirements is a plus.
  • Experience in matrix organization, operating and communicating with senior level management, both internally and externally, and managing interdepartmental processes.
  • Strong business acumen and demonstrated improvements of business performance (optimization of cost, resources, results, etc.), as well as sound understanding of relevant financial and legal aspects.
  • Experience with ERP/MRP systems
  • Experience in leading and managing in an international environment.
  • Ability to think critically and fast, to make both strategic and tactical decisions in design, management and execution of the sourcing and external manufacturing alliances.
  • Masters matrixed organization skills and is politically savvy, with strong communication abilities – cross-functional and cross-cultural awareness.
  • Planning and prioritization with strong organizational development and change management skills.

Results focused and customer service orientated self-starter.
  • Strong at engaging and developing talent and organization; as well as management and leadership skills.
  • Proven track record of negotiating, both with internal stakeholders and with external contract negotiations.
  • Excellent writing, editing and computer skills including MS Office (Word, PowerPoint, Excel, Vision) and other planning and mapping tools.


Location: Emeryville, CA

For more information about our company and the work experience, please visit www.santenusa.com.