Manager Of R&D, And Tech Services

Job Summary

The Manager of R&D and Tech Services will be responsible for leading and managing day-to-day R&D and Validation functions at our ImprimisRx 503B outsourcing facility, providing leadership, guidance, and hands-on direction across various activities within the department, including personnel, practices, and processes.

Core Responsibilities

• Responsible for leading R&D team for end-to-end activities from development of lead formulation and process to support manufacturing and launch of new products.
• Designing experiments in the laboratories, pilot plants, or manufacturing sites to identify the critical quality attributes of the process and establish appropriate process control.
• Develop and implement validation strategies for equipment, processes, cleaning, and systems in compliance with FDA and other regulatory guidelines.
• Provide leadership to the validation team for activities including but not limited to process validation, cleaning validation, equipment validation, and computer systems validation.
• Establish new manufacturing processes and/or refine existing ones to optimize processes and ensure quality, using statistical tools and proven scientific methods.
• Identify opportunities to optimize sterile/aseptic processes, reduce costs, and enhance quality across R&D and validation. Implement best practices and lead initiatives to drive continuous improvement efforts.
• Foster collaboration and technical/scientific communication with internal departments such as Quality Assurance, Manufacturing, and Supply Chain to achieve project goals and timelines related to R&D and Validation and improvement of product quality.
• Review of technical reports and specifications, and maintaining appropriate records for product and process development projects to ensure smooth process technology transfer.
• Troubleshooting and resolving manufacturing process problems-determining root cause and corrective actions using strong scientific reasoning.
• Developing process documentation and training materials to support the standardized processes and product launches.
• Effectively work with cross-functional teams to streamline development, validation, scale up, and launch activities.
• Perform review and approval of method validation and method transfer protocols and reports.
• Monitor the progression of development through each phase across all projects.
• Supervise the tech transfer of all products from R&D to manufacturing for new and existing products.
• Candidate must coordinate research and development analytical activities as required.
• Provide mentorship to the staff to enhance their personal and professional growth.
• Provide adequate supervision of personnel and guidance for the team's professional development.

Qualifications & Requirements

• MS degree in Chemistry, Pharmaceutical Sciences. Ph.D. degree a plus.
• Must have eight to ten years of industrial experience in formulation, process development, and validation. Experience in ophthalmic dosage preferred.
• Strong technical and scientific reasoning, tech transfer skills, and experience working alongside a manufacturing facility.
• Experience working with contract research laboratories in a fast-paced environment.
• Proven problem-solving, troubleshooting, and critical thinking skills.
• Practical interpersonal skills with solid communication skills, both verbal and in writing.
• Strong quantitative skills, proven attention to detail, and practical organizational skills.
• Maintains broad knowledge of scientific principles and theories and possesses an intellectual mastery of one or more scientific areas.
• Advanced knowledge and demonstrated ability to work with / recommend various laboratory equipment/tools.
• Able to work as part of and lead multiple teams.
• Exhibits leadership skills.
• Sees broader picture, impact on multiple programs, teams, and departments.
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.

Position Type

• On-Site