Formulation Science Director

4 weeks ago

Mountain View, California, United States Talnt Full time

About the Role

The Director of Formulation Science will lead a team focused on developing and optimizing advanced formulations, including lipid-based systems, nanoparticle technologies, and cosmetic/topical products. This role involves hands-on involvement in both R&D and scale-up processes, ensuring new formulations meet scientific and regulatory standards.

Responsibilities:

  • Lead the design and development of projects aligning with global development plans.
  • Oversee and implement advanced methodologies for formulation development, focusing on lipid-based and nanoparticle systems.
  • Design, prepare, and characterize formulations using techniques such as particle size analysis, surface charge measurements, DSC, TGA, and HPLC.
  • Develop and scale up new formulation technologies, including topical and cosmetic systems.
  • Set up and manage the lipid formulation laboratory, ensuring equipment maintenance and adherence to safety and regulatory standards.
  • Maintain detailed lab notebooks, records, and reports per regulatory and department guidelines.
  • Draft regulatory submissions and present project summaries for internal and external stakeholders.
  • Train, lead, and manage a growing team of scientists and technicians.
  • Represent the company in dealings with contract research/manufacturing organizations (CROs/CMOs).

Qualifications:

  • Proven expertise in lipid-based formulations and nanoparticle systems, with experience in both R&D and product scale-up.
  • Hands-on experience with cosmetic and topical formulation techniques, particularly in gels, creams, and serums.
  • Strong scientific background, particularly in pharmaceutical chemistry, with the ability to lead development from concept through to NDA submission.
  • Demonstrated ability to prepare and submit regulatory documentation.
  • Proven track record of outsourcing to CMOs/CROs and managing tech transfers.
  • Solid knowledge of GLP/GMP regulations and practices, with hands-on GMP experience being highly desirable.
  • At least 5 years of management experience, with the ability to train and lead teams.
  • Familiarity with nonclinical development requirements is an advantage.

Preferred Qualifications:

  • PhD in a relevant scientific discipline, with 10 years of experience in formulation development, particularly with ophthalmic or injectable dosage forms.
  • Strong experience with lipid formulations, including liposomes, lipid emulsions, micelles, and nanolipid systems.
  • Expertise in physiochemical characterization techniques, such as HPLC, DSC, TGA, and X-Ray Powder Diffraction.
  • Familiarity with biopharmaceutics principles, clinical PK data, and their application to formulation optimization.
  • Experience in Design of Experiments (DoE) and Quality by Design (QBD) methodologies.
  • Proficiency with analytical instrumentation and preparative chromatography, including LCMS.
  • Previous experience in pharmaceutical manufacturing and operations, with in-depth knowledge of CGMP and GLP principles.
  • Bonus
  • Equity
  • Relocation assistance
  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Remote Work: No

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