Join our innovative start-up company, dedicated to advancing cutting-edge cell-based therapy solutions for common and severe clinical challenges.
We seek a highly motivated individual to lead the design and optimization of drug formulations, ensuring stability, efficacy, and safety for clinical and commercial use. The ideal candidate will have a deep understanding of regulatory requirements
Key Responsibilities:
Designing and optimizing formulations for cell-free therapy products.
Conduct formulation studies, stability assessments, and compatibility tests to evaluate product performance and shelf-life under physiological conditions.
Developing and maintaining comprehensive documentation, including formulation development reports, regulatory submissions, and manufacturing instructions, adhering to FDA regulations and guidelines.
Keeping abreast of the evolving regulatory landscape, emerging technologies, and scientific advancements in cell-free therapy to inform formulation strategies and ensure regulatory compliance.
Requirements: Advanced degree (Ph.D. or M.S.) in biochemistry, biotechnology, pharmaceutical sciences, or related field.
Extensive experience in formulation development for cell or cell-free therapy products.
In-depth knowledge of regulatory requirements and guidelines governing cell-free therapies, including FDA regulations, GMP, and relevant standards advantage.
Strong analytical skills and problem-solving abilities, with the capacity to interpret complex scientific data and apply findings to formulation design and optimization.
This position is open to all candidates.
