Executive Director, Commercial Manufacturing

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Duties and Responsibilities

• Oversee hiring to build an effective drug substance manufacturing team; create and communicate a clear vision among direct reports, effectively align resources, and motivate teams to achieve goals.
• Manage drug substance CMOs for manufacturing operations, technology transfers, investigations, and batch documentation reviews and responsible for continuous improvement and operational excellence at CMOs.
• Develop and Lead Drug Substance Strategy that includes areas for process improvements which lead to cost savings and/or manufacturing efficiencies
• As a leader on the Commercial Manufacturing Team, integrate internal and external team activities into the manufacturing operations and present plans and progress to the Senior Leadership Team.
• Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply chain to support company objectives.
• Champion regulatory and technical documents for regulatory submissions in support of manufacturing and serve as subject matter expert in regulatory interactions.
• Maintain a high level of safety, compliance, and efficiency to drive the organization to world-class manufacturing standards.

Key Core Competencies

• Strong leadership skills, including demonstrated ability to lead a cross-functional team, and to influence at all levels of a matrix organization.
• An entrepreneurial approach to develop new, innovative ideas that will drive growth within the Manufacturing organization.
• The ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion.
• Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
• Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates and issues to the executive leadership.
• Develop effective and efficient working relationships with both internal and external partners.
• Available to travel domestically and international if/when needed.

Education and Experience

• PhD or MS Chemistry, Biology, or related field
• Proven active leader in bringing clinical molecules to successful commercial products within different Global Markets, including leading regulatory filings
• Successfully executed Process Improvement/Operational Excellence to benefit the manufacturing process
• People leader with managing department budget
• >25% Travel domestically and  internationally
• 20+ years (w/o Master’s) or 15+ (with Master’s) of relevant experience in biotech or pharmaceutical industry

The base salary range for this role is $250,200 to $312,800. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be