Senior Director, Formulations

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational 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 Overview

We are looking for a motivated, and forward-thinking professional to join our team as Senior Director of Formulation Development.  The Senior Director, Formulation Development, leads the drug product development function at SMPA, overseeing all aspects of formulation and process development for small molecules and other modalities from discovery through commercial launch. This role provides scientific expertise in oral solid dosage forms, manages GMP manufacturing at contract sites, liaises with R&D and SMP CMC functions and authors global regulatory filings (INDs, IMPDs, NDAs). Reporting to the VP, CMC Development, the Senior Director collaborates cross-functionally to drive CMC strategy, ensure regulatory compliance, and support lifecycle management. This is a remote position with occasional travel for stakeholder meetings.

Job Duties and Responsibilities

• Define and execute formulation development strategies aligned with corporate goals and timelines.
• Oversee design, development, and characterization of formulations for clinical and commercial use, including excipient selection and delivery technologies.
• Manage outsourced development activities, including technology transfer, scale-up, and clinical manufacturing at CMOs.
• Ensure technical content and readiness for regulatory submissions and responses, serving as SME for oral solid dosage form development.
• Collaborate with SMP CMC, Analytical Development, Supply Chain, Quality, Regulatory, and Nonclinical teams to support development programs and ensure continuous clinical supplies.
• Lead, coach, and develop reports and team members, fostering a culture of scientific excellence, innovation, and continuous improvement.
• Develop and manage function resources and budgets and ensure timely documentation of technical information for regulatory filings.
• Evaluate and manage relationships with CDMOs, academic collaborators, and technology providers; represent the company at scientific conferences when needed.
• Support due diligence and business development opportunities.

Key Core Competencies

• Effective communication and influence across technical and business audiences
• Leadership, coaching, and talent management
• Strategic thinking and cross-functional collaboration; ability to adapt in a fast-paced environment
• Deep understanding of formulation principles, oral solid dosage forms, and GMP manufacturing
• Scientific and technical expertise in pharmaceutical formulation development
• Solid understanding of drug product configurations
• Experience with technology transfer, scale-up, and outsourced manufacturing
• Regulatory knowledge (ICH, FDA, EMA) and experience with global filings
• Quality by Design (QbD) principles and global quality standards
• Analytical and problem-solving skills
• Project and resource management, including budgeting
• Vendor and partner relationship management
• Commitment to continuous improvement and fostering a positive team culture
• Organizational awareness and ability to understand interdependencies and the big picture
• Demonstrated success in resource-constrained environments with a solutions-first mindset

Education and Experience

• PhD in Pharmaceutical Science or related field with 10+ years) and at elast 5 years in a leadership role.

• Minimum 15 – 20 years (with Bachelor’s) or 10 – 15 years (with Master’s) in pharmaceutical formation development, with at least 5 years in a leadership role.

• Proven track record in pre-formulation, formulation development, process selection, scale-up, and GMP manufacturing oversight.

• Deep understanding of regulatory requirements (ICH, FDA, EMA), QbD principles, and global quality standards.

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