Director of Formulations

JOB Description

Turn Biotechnologies is seeking an excellent lipid-based formulations, nano-particles based system, and cosmetic/topical system director for our formulation group.

Responsibilities:

Essential duties include but are not limited to:

• 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.

Qualifications

General

• 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.
• CMC/ Pharmaceutical Development
• 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.
• Customer & Industry Knowledge
• Experienced in pharmaceutical manufacturing and operations and the application of CGMP and GLP principles.

EDUCATION/EXPERIENCE

• PhD with 10+ years of experience in formulation development and scale-up for ophthalmic and/or injectable dosage forms.

DESIRABLE CHARACTERISTICS

• Excellent organizational, oral and written communication skills.
• Ability to work independently and cross-functionally with teams to achieve goals.
• Proficient in presenting data and results in group settings.
• Flexibility, with an ability to prioritize/accommodate demanding work schedules, as required.
• Emotionally intelligent; a “whatever it takes” attitude.