MS in Chemistry or Pharmaceutical Sciences; Ph.D. preferred.
8-10 years of experience in formulation, process development and validation; ophthalmic dosage experience preferred.
Strong technical reasoning and experience with tech transfer.
Experience in a fast-paced environment with contract research laboratories.
Proven problem-solving, troubleshooting, critical thinking, and communication skills.
Responsibilities
Lead R&D team in development of product formulations and manufacturing processes.
Design experiments for quality attribute identification and process control.
Develop and implement validation strategies for compliance with FDA standards.
Provide leadership for all validation activities including process, cleaning, equipment, and systems.
Optimize and refine manufacturing processes using scientific methods and statistical tools.
Identify and implement improvements in sterile processes to enhance quality and reduce costs.
Foster collaboration across departments to meet project goals and improve product quality.
Benefits
Mentorship and professional development opportunities.
Collaboration with cross-functional teams.
Participation in continuous improvement initiatives.
Hands-on leadership and ownership of diverse projects.
Full Job Description
Job Summary
The Sr.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.
