Director of Formulations

JOB DESCRIPTION

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

COMPANY

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:

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 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 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).

• 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.

Turn Biotechnologies is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

WHY TURN?

We are a close-knit, collaborative team, passionate about anti-aging and longevity and it's impact and improvement of age-related disease and the quality of people’s lives

• Competitive compensation

• Benefits Package

• Fully-paid employee medical, dental, vision, & life insurance)

• 401K

• FSA

• Flexible PTO

• Employee Assistance ProgramTurn Biotechnologies is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status or disability status.

You will be a vital part of the company and have a tremendous impact on its success.

Equal Opportunity Employer Statement: Turn Biotechnologies is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. We do not discriminate on the bases of race, color, religion, sex, age, national origin, veteran status, disability, genetic information, pregnancy, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company.

Occupational Health and Safety: Turn Biotechnologies provides a workplace free from recognized hazards and complies with standards, rules and regulations issued under the OSH Act.