The Manager of MS&T (Manufacturing Science and Technology) will be responsible for leading and managing day-to-day R&D and Validation functions at our outsourcing facility providing leadership, guidance, and hands-on direction in various activities within the aegis of the department, including personnel, practices, and processes.
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 and performing experiments in the laboratories, pilot plants or manufacturing sites to identify the critical to 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. Ensure validation protocols and reports are accurate and comprehensive.
Provide leadership to 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 refining existing ones with the aim of optimizing the processes and ensuring quality using statistical tools and proven scientific methods.
Identify opportunities for sterile/aseptic process optimization, cost reduction, and quality enhancement within R&D and validation processes. 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.
Assessing manufacturing process capability and assisting with process variability reduction and process improvement initiatives as needed.
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.
Recommend and implement best practices and maintain company accuracy, productivity, and efficiency standards.
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.
Contribute to the development of policies and department strategies.
QUALIFICATIONS
MS degree in Chemistry, Pharmaceutical sciences. Ph.D. degree a plus.
Must have six to eight years of industrial experience in formulation , process development and validation Experience in ophthalmic dosage preferred.
Strong technical and scientific reasoning, tech transfer skill and experience working alongside 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 verbally and in writing.
Strong quantitative skills, proven attention to detail with 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.