Abeona is looking for a Senior Scientist, Process Development, to join our team in Cleveland, OH. The successful candidate will be responsible conducting Process Development for clinical and/or commercial purposes in diverse biological areas and for a variety of products. Skilled in leading process development, its principles and practices. Relies on extensive experience and judgment to plan, budget, execute and accomplish goals and can coordinate with leaders in other disciplines (AD, QC, Mfg, QA, Reg, etc.) for comprehensive project planning and coordinated execution.
Essential Duties and Responsibilities
Initiates, plans, and executes all aspects of project leadership and project management in multiple development studies for new processes or key process improvements (includes protocol and report writing; laboratory skills training and SOP documentation needs, etc.)
Identifies and evaluates new scientific approaches or methods to improve the products/processes of Abeona
Serves as an internal Subject Matter Expert (SME), advises management on process/product issues
Provides leadership and input with others on multidisciplinary teams for planning, implementation, analyses and problem solving
Lead CMC contributor in SME areas
Represents the company at external manufacturing/scientific conferences
Bachelor's degree in science and 10 or more years relevant experience, or
Master's degree in science and 7 or more years relevant experience, or
PhD in science with 4 to 7 years relevant experience
Other Skills and Abilities
Demonstrates ability to lead and teach Process Development Associates and Scientists and perform technology transfers as appropriate.
$80K - $85K