Reporting to the Head of R&D, the R&D Formulation Chemist will be responsible for the development, optimization, and scale-up of ophthalmic formulations, ensuring compliance with regulatory guidelines and quality standards.
The R&D Formulation Chemist will support planning and execution of our clinical research protocols and studies primarily in ophthalmology, with additional responsibilities in dermatology.
This role involves collaboration with cross-functional teams, including medical affairs, quality and regulatory affairs, ideation, and manufacturing. The location for this role will be based between our Dublin office and laboratory in Cherrywood, Dublin 18.
Key Responsibilities
Research and technical insights
· Identify, evaluate and source innovative ingredients and technologies that can be used for a wide range of formulations & concepts within the SCOPE eyecare portfolio.
· Using market research and competitor insights to propose new concepts for our current markets and identify new business opportunities.
· Carry out patent research and IP opportunities for new formulations.
· Support the marketing team on market research and evidence analysis as part of the evaluations of new projects.
· Working with sales and marketing teams to identify new projects and new products.
Formulation design and development
Design and develop ophthalmic formulations (solutions, suspensions, emulsions, gels, ointments) from concept to commercialization.
Pre-Formulation Studies: Conduct solubility, stability, and compatibility studies for active pharmaceutical ingredients (APIs) and excipients.
Optimize manufacturing processes, including mixing, sterilization, and filling, ensuring scalability and reproducibility.
Conduct and interpret stability testing under ICH guidelines to establish formulation shelf-life.
Ensure formulations meet regulatory requirements (FDA, EMA, ICH) and contribute to the preparation of CMC (Chemistry, Manufacturing, and Controls) documentation.
Support scale-up and technology transfer from R&D to manufacturing for clinical and commercial production.
Work closely with CMO’s for method development, validation, and release testing.
Research and implement novel excipients, delivery technologies, and formulation techniques for enhanced ocular delivery systems.
Maintain accurate and detailed documentation of experiments, protocols, and reports as per Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards.
Collaborate with regulatory, quality, and medical affairs teams to support product development and regulatory submissions
Clinical testing support and claims
· Collaboratively design comprehensive pre-clinical and clinical studies focusing on ophthalmology. Ensure protocols are robust, aligning with target product profiles and regulatory requirements.
· Support medical affairs with postlaunch requests.
· Support quality and medical with quality investigations and complaints.
· Support with education on ingredients and formulations.
Networking and collaboration
· Meet with raw material suppliers to learn about new technologies and new raw materials that can be utilised to create and or improve Scope’s innovative offerings.
· Carries out field visits with Scope’s Business Development Managers and senior managers to get a good understanding of our customers wants and needs regarding new product development.
· Collaborate as a key team member with ideation and innovation team, contributing with innovative ideas and expertise.
Project management and communication
· Communicate all information regarding formulation, project status, costing, and results to all appropriate individuals, maintaining confidentiality requirements.
· Provides regular project status updates and reports as needed.
· Work with the relevant regulatory bodies or regulatory consultants to ensure the correct process and procedures are carried out for the launch of a new product.
· Ensure all specifications and costing information is checked routinely and is factually correct prior to go to market planning or market launch.
· Successfully delivers new product assignments using strong project management principles and effective stakeholder management.
Person Specification
Qualifications
· BSc Science or related science discipline
Specific Knowledge, Skills and Experience
· 3+ years’ experience as an R&D formulation chemist.
· Must have a passion for eyecare with an excellent understanding of the market.
· Proven experience in formulation and manufacturing process knowledge.
· Technical expertise in ophthalmic formulations such as solutions, suspensions, emulsions, gels, ointments.
· Proven experience formulating in a laboratory, laboratory prototypes and manufacturing scale up.
· Experience working with laboratory equipment relating to formulation development and manufacturing.
· Experience working with other departments such as Finance, Marketing, Sales, Supply Chain, Quality Control, Manufacturing, Quality Assurance and Medical and Regulatory Affairs.
· Proven experience in GMP and cGMP and heavily regulated environments.
· A commercially focused person who can combine creativity with an understanding of full-scale production practicalities and regulatory compliance.
· Can demonstrate excellent Project management skills.
· Can make decisions and manage effectively within a fast paced and changing environment.
· Ability to work effectively within strict cost / time parameters.
· Exceptional awareness of detail through all the stages of processes of new product development.
· Driven to deliver on goals and objectives, this person can also work effectively within a cross functional team.
· Computer literate across Excel, Word, PowerPoint and Adobe Suite.
· Excellent verbal and written communication skills.
· Has the flexibility and desire to travel regularly within Ireland, UK and International. Is prepared to attend exhibitions & conferences outside normal office hours.
· Full driving licence essential.