Director of Manufacturing Science & Technology MS&T

Role Summary

The Senior Director of Manufacturing Science & Technology (MS&T) provides strategic leadership for technology transfer, process development, and validation activities in ophthalmic drug manufacturing, ensuring scientific excellence and operational efficiency across the organization. This role leads a multidisciplinary team to drive innovation and optimize performance at contract manufacturing facilities, collaborating with R&D, Engineering, Quality Assurance, and Regulatory Affairs. The position advances scientific capabilities, evaluates emerging technologies, and embeds best practices to strengthen competitiveness and enable sustained growth.

Responsibilities

• Provide strategic direction and technical leadership for technology transfer, scale-up, and validation of ophthalmic drug products and manufacturing processes at qualified CMO facilities.
• Lead and manage end-to-end tech transfer of branded ophthalmic products to cGMP facilities, including CMO scouting, technical capability assessments, project management, deliverables, technical input, and troubleshooting.
• Oversee all phases of project execution from initiation and tech package review through manufacturing support and commercial launch at new CMOs.
• Direct day-to-day technical services functions, ensuring effective guidance, oversight, and hands-on support across personnel, practices, and processes.
• Design, execute, and manage validation studies, including protocol development, data analysis, and review/approval of scientific reports for regulatory submissions.
• Troubleshoot and resolve manufacturing issues by applying strong scientific reasoning to identify root causes and implement corrective actions.
• Collaborate with cross-functional teams to streamline tech transfer, validation, and product launch activities.
• Recommend and implement best practices to ensure accuracy, productivity, and efficiency standards are consistently met.
• Provide technical feedback and scientific insights to enhance product quality across functions.
• Track and monitor project progression through all development phases.
• Mentor and supervise staff, fostering both professional development and team growth.
• Contribute to the development of departmental policies, strategies, and long-term direction.
• Promote and drive a culture of continuous improvement.

Qualifications

• MS degree in Chemistry; Pharmaceutical Ph.D. degree a plus.
• Eight to ten years of industrial experience in CMC, formulation, and process; experience in ophthalmic dosage preferred.
• Strong tech transfer skills and experience working alongside manufacturing.
• Experience working with contract research laboratories in a fast-paced environment.
• Proven problem-solving, troubleshooting, and critical thinking abilities.
• Practical interpersonal skills with solid verbal and written communication.
• Strong quantitative skills, attention to detail, and organizational abilities.
• Broad knowledge of scientific principles with expertise in one or more scientific areas.
• Advanced knowledge and ability to work with various laboratory equipment/tools.
• Ability to lead multiple teams and collaborate across functions.
• Demonstrated leadership and the ability to see the broader impact across programs and departments.
• Ability to meet multiple deadlines across projects with accuracy and efficiency.

Skills

• Technology transfer
• Process development
• Validation studies
• Project management
• Regulatory submissions support
• Cross-functional collaboration
• Problem solving and troubleshooting
• Leadership and mentoring

Education

• MS in Chemistry required; Ph.D. in Pharmaceuticals or related field preferred.

Additional Requirements

• Position Type: Remote
• Travel: Up to 25%