Director Of Formulation Science

1 month ago

Mountain View, United States Talnt Full time

About the Role

The Director of Formulation Science will be responsible for leading a team focused on the development and optimization of advanced formulations including lipidbased systems nanoparticle technologies and cosmetic/topical products. This role involves handson involvement in both R&D and scaleup processes ensuring that new formulations meet both scientific and regulatory standards. The ideal candidate will bring a strong background in pharmaceutical and cosmetic formulation exceptional leadership skills and a proven ability to drive projects from concept to regulatory submission. As a senior leader in the company this position offers an exciting opportunity to shape the future of cuttingedge formulation technologies.

Responsibilities:

  • Lead the design and of development projects aligning with global development plans.
  • Oversee and implement advanced methodologies for formulation development focusing on lipidbased and nanoparticle systems.
  • Design prepare and characterize formulations using techniques such as particle size analysis surface charge measurements DSC TGA and HPLC.
  • Develop and scaleup 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 lipidbased formulations and nanoparticle systems with experience in both R&D and product scaleup.
  • Handson 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 handson 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 XRay 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 indepth 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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