Director of Formulation Science

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.