SUMMARY
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.
