Research And Development Manager, and Tech Services

Sr. Manager of R&D and Tech Services Core Responsibilities

• Lead R&D team for end-to-end activities from lead formulation and process development through manufacturing and launch of new products.
• Design experiments to identify critical quality attributes and establish process control.
• Develop and implement validation strategies for equipment, processes, cleaning, and systems in compliance with FDA and other regulatory guidelines.
• Lead validation activities including process validation, cleaning validation, equipment validation, and computer systems validation.
• Establish or refine manufacturing processes to optimize performance and quality using statistical tools and scientific methods.
• Optimize sterile/aseptic processes to reduce costs and enhance quality; implement best practices and continuous improvement initiatives.
• Collaborate with Quality Assurance, Manufacturing, and Supply Chain to meet R&D/Validation project goals and timelines.
• Review technical reports/specifications and maintain records to support process technology transfer.
• Troubleshoot manufacturing process problems; determine root cause and corrective actions.
• Develop process documentation and training materials to support standardized processes and product launches.
• Work with cross-functional teams to streamline development, validation, scale-up, and launch.
• Review/approve method validation and method transfer protocols and reports.
• Monitor development progression through each phase across projects.
• Supervise tech transfer from R&D to manufacturing for new and existing products.
• Coordinate R&D analytical activities as required.
• Mentor and supervise staff to support professional development.

• MS in Chemistry or Pharmaceutical Sciences;
  Ph.D. a plus.
• 8–10 years industrial experience in formulation, process development, and validation; ophthalmic dosage experience preferred.
• Strong technical/scientific reasoning, tech transfer skills, and experience working alongside a manufacturing facility.
• Experience with contract research laboratories in a fast-paced environment.
• Proven problem-solving, troubleshooting, and critical thinking.
• Strong written and verbal communication and interpersonal skills.
• Strong quantitative skills, attention to detail, and organizational skills.
• Broad knowledge of scientific principles; mastery in one or more scientific areas.
• Advanced knowledge and ability to work with/recommend laboratory equipment/tools.
• Ability to work on and lead multiple teams; demonstrated leadership.
• Ability to meet multiple deadlines across projects with high accuracy/efficiency.

• On-site