Director of Formulations

About the position

Turn Biotechnologies is seeking an excellent lipid-based formulations, nano-particles based system, and cosmetic/topical system director for our formulation group. Based in Mountain View, California, Turn Biotechnologies, Inc. is a development-stage company focused on restoring cells' youthful vigor to repair damage caused by the aging process. Using a proprietary ERA Platform, we develop mRNA medicines that are specially formulated to instruct specific cells in the body to fight disease or repair damaged tissue. We do this by reprogramming the epigenome to restore cell function that people often lose as they age. This approach can be used to revitalize different cells throughout the body. We are researching its applicability across multiple therapeutic areas, including dermatologic conditions, pulmonary disease, osteoarthritis and ophthalmology.

Responsibilities

• Leading the design and execution of development projects, integrating functional activities with global development plans.
• Utilizing cutting-edge development and preparation methodologies and techniques to design and execute efficient formulation processes.
• Designing, preparing and characterizing formulations using a variety of techniques, including but not limited to particle size, surface charge, DSC, TGA, and HPLC.
• Enabling the development and scale of new technologies.
• Potentially helping to set up and manage a lipid formulation lab, cosmetic/topical delivery and maintaining the lab instruments.
• Maintaining all appropriate corporate standards for lab safety and hazardous material management; executing daily operations with an approach designed to minimize risks and hazardous waste streams.
• Maintaining a lab notebook, instruments and inventory records in accord with department guidance and regulatory requirements.
• Drafting reports and preparing and presenting summaries of work for department and projects. Writing regulatory submissions.
• Training, leading and directly managing staff as the company grows.
• Functioning as the company representative at contract research/manufacturing organizations.

Requirements

• Prior experience with lipid-based formulation, nano-particle systems and scale-up.
• Record of excellence in lipid-based formulation research with innovative contributions.
• Desire to be hands-on.
• Strong experience in different stage of cosmetic/topical formulations and delivery systems.
• Strong scientific background and technical expertise with the ability to apply it to product development.
• Capability and experience in leading projects from early development to NDA stage.
• Experience in the preparation of regulatory submissions.
• Experience with outsourcing work to CMOs or CROs, tech transfer and supervision.
• Knowledge of GLP/GMP and other regulatory guidelines. Hands-on GMP experience would be an asset.
• Demonstrated accomplishment and leadership in pharmaceutical chemistry development and operations.
• Knowledge of non-clinical requirements is a plus.
• At least 5 years of management experience.

Nice-to-haves

• Strong experience in lipid formulations (liposome, lipid emulsions, micelles, nano-lipid formulations).
• Solid experience in developing gels, serum, lotion, cream and other cosmetic formulations. Knowledge in characterization of those formulations.
• Experience in physio-chemical characterization of lipid formulations is a must.
• Application of biopharmaceutics principles and clinical PK data towards formulation development and optimization.
• Experience in DoE & QBD application during formulation, process development and scale-up activities.
• Knowledgeable in recent advances of formulation and delivery technologies.
• Track record of working closely with Research and Development teams, support testing of new drug formulations at various stages of development and meeting project timelines and goals.
• Experience with analytical instrumentation, including High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Karl Fischer (KF) titration, dissolution apparatus. Experience with Differential Scanning Calorimetry (DSC), Thermal Gravimetric Analysis (TGA), X-Ray Powder Diffraction (XRPD).
• Strong and independent problem-solving and troubleshooting abilities.
• Preparative chromatography and LCMS experience is a plus.