Turn Biotechnologies is seeking an excellent lipid liposomal and nano-formulations at PhD/MS level in our lipid 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.
Essential duties include but are not limited to:
Leading the design and execution of development projects, integrate 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 particle size, surface charge, DSC, TGA, HPLC, etc.
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.
Ideally, training, leading and directly managing staff as the company grows.
Functioning as Turn-Bio representative at Contract Research/Manufacturing Organizations.
Prior experience with lipid nano-particle formulation and scale-up.
Record of excellence in lipid-based formulation research with innovative contributions.
Desire to be hands-on.
Strong technical expertise with the ability to apply it to product development.
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
3-5+ years of supervisory experience desirable.
CMC/ Pharmaceutical Development
Strong experience in lipid formulations (liposome, lipid emulsions, 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.
BS/MS with 10+ years or PhD with 4-to-8 years of experience in formulation development and scale-up for ophthalmic and/or injectable dosage forms. At minimum, MS in technical field.
At least 3 years of supervisory experience desirable.
Excellent organizational, oral and written communication skills.
Ability to work independently and 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.
Experienced writing scientific reports.
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.