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Formulation Scientist
4 months ago
Responsibilities
- Plan and execute formulation development activities for parenteral administration for nucleic acid therapeutics and gene-therapy products.
- Carry out process development activities for parenteral formulations.
- Perform formulation and process transfer activities from lab to the manufacturing floor.
- Develop liquid formulation technologies to enhance patient compliance such as pediatric formulations or injectable sustained delivery systems.
- Provide technical support to regulatory submissions of new and existing drugs and act as a spokesperson on development related aspects during FDA inspections.
Minimum Requirements
- Master's degree or PhD in pharmaceutical sciences, industrial pharmacy, or related field.
- 3 - 8 years of experience in pharmaceuticals development, formulations, or related roles.
- Proven experience in aseptic process development on injectable solutions and suspensions.
- Drug product development experience that spans from early through late phase is required.
- Good oral, written communications skills, and a strong command of the English language.
- Prior work experience with lipid nanoparticles or other encapsulation technologies for solution or suspension formulations.
Desired Qualifications
- Comprehensive understanding of the current trends in biomanufacturing for pharmaceuticals.
- Good knowledge in either mRNA, pDNA or viral-vector therapeutics.
FDA
HPLC
Treatment
Formulation
Application Development
Drug Delivery
Administration
Chemistry
Written Communications
Product Development
Regulatory Submissions
Laboratory
Manufacturing
Chemical Engineering
Skin Care
Technical Support