Research And Development Manager, and Tech Services
Harrow
5 months ago
On-site
Ledgewood, NJ
Clinical Research and Development
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.
Qualifications & Requirements
- 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.
Position Type
- On-site
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.
Qualifications & Requirements
- 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.
Position Type
- On-site