Director Of Formulation Science
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 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
Employment Type
Full Time
