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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Executive Director, Commercial Manufacturing. This role is responsible for setting and executing strategic directions to ensure the successful delivery of SMPA's commercial portfolio of products. The Executive Director will lead the RSM/API department, by alignment with business objectives and operational excellence across all commercial manufacturing suppliers.
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 is required.
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 (with Master's) or 15+ (with PhD) 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 offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
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Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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 (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
Our Mission
To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide
Our Vision
For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas
