This role will be responsible for the designing and building of scalable drug product prototypes within the Pharmaceutical Development team working towards the commercial development of a sustained release hydrogel-based drug product for use in the treatment of an ophthalmic indication. This individual will work collaboratively with group and cross-functional project team members and implement program plans in line with team and corporate goals. They will communicate with team members and management to present activities, plans, and updates on program goals.
Principal Duties and Responsibilities include the following:
Develop, build, and demonstrate highly scalable, reproducible implant production processes to meet intravitreal implant commercial demand projections.
Perform hands-on production and analysis of process development studies to define critical process parameters and in-process controls.
Work with outside vendors, when necessary, in the development of custom equipment to support manufacturing scale-up and process improvement efforts.
Design developmental stability studies as needed to support improved production workflow.
Document work in technical reports, batch records, and protocols in support of scale-up and process improvement strategies.
Collaborate effectively while participating in cross-functional teams to communicate study design, project status, data analysis, and program plan to project team members, including senior management.
Work within teams to meet project goals, with a specific emphasis on leading efforts to produce and characterize process improvements.
Qualification Requirements:
Degree in Chemistry, Pharmaceutics, Materials Science, Biomedical, Mechanical, or Chemical Engineering or related discipline. PhD with 0+, MS with 3+, or BS with 5+ years of relevant drug product research, development, or manufacturing experience is desired.
An ideal candidate will have expertise in hydrogel formulation for the sustained release of small molecules.
Experience in drug product formulation development and process scale-up supporting CMC elements towards regulatory submissions.
An understanding of phase-appropriate drug product requirements and applicable GMP manufacturing regulations including batch records, raw materials, product specifications and pertinent documentation supporting regulatory submissions.
Demonstrated ability to apply strong fundamental scientific and engineering skills in the evaluation of processes and development of practical solutions to technical challenges.
Use of statistical methods for process and design space optimization is beneficial.
Experience in sustained release formulations, tyrosine kinase inhibitors, and ophthalmic indications is a plus.
An understanding of vision systems and analytical characterization is a plus.
Strong presentation and written communications skills.
Proficiency in Solidworks and custom designed components is beneficial.
A knowledge of statistical programs such as JMP is a plus.
A collaborative, hard-working, team player passionate about science who can effectively work in a dynamic, cross-functional team environment.