Director of Formulation Science

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Job description

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 lipid-based systems, nanoparticle technologies, and cosmetic/topical products. This role involves hands-on involvement in both R&D and scale-up 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 cutting-edge formulation technologies.

Responsibilities:

Lead the design and execution of development 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 non-clinical 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 nano-lipid systems.

Expertise in physio-chemical 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

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