About Ascendia Pharmaceuticals:
Ascendia is a start-up specialty pharmaceutical company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates. Ascendia specializes in creating formulations for poorly-water soluble molecules using nano-particle technologies. Ascendia assesses the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability and solubility. Ascendia’s technologies include nano-emulsions, amorphous solid dispersions, nano-particles, injectable, and oral controlled release. Ascendia provides development and testing services – from discovery-stage molecules to life-cycle-management projects – creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up.
The mission of our company is to provide customized formulation solutions to “salvage” difficult compounds and to create advanced medicines to help patients “prevail” over theirdisease and enhance quality of life.
About the Position:
Ascendia Pharma is looking for formulation scientists for its Pharmaceutical R&D. This position will conduct activitiesrelated to formulation development under research and development settings. The successful candidate will be actively involved in developing formulation and manufacturing process and transferring these methods and processes to drug product manufacturers. The ability to work effectively in a collaborative, interdepartmental team environment is essential to this role with the expectation that this scientist will interact with all disciplines of drug development, including discovery, pre-clinical, clinical, preformulation, analytical R&D, and regulatory. A thorough understanding of pharmaceutical development process from discovery to commercialization is highly desirable.
- Design formulations and process for complex and challenging compounds.
- Actively involved in project management and product development strategies. Handle all technical, legal, and regulatory aspects of development projects.
- Participate in discovery and clinical development project team to inform and update the team on the status of all active projects
- Write and review CMC reports and documentation for regulatory filings.
- Keep current with regulatory guidelines, technical innovations, and new developments within pharmaceutical industry.
- The position requires a M.S. or Ph.D. degree in Pharmaceutics, Physical Pharmacy, Chemical Engineering, or Pharmaceutical sciences with relevant pharmaceutical experience. A candidate with a Bachelor degree in a relevant field and extensive industrial experience will be also considered.
- Industrial or academic experience in solid oral or parenteral dosage form development, process optimization and scale-up.
- Experience in Innovative approaches to solving formulations challenges and formulation technologies to improve solubility and bioavailability of poorly water soluble drug ispreferred.
- In-depth understanding of preformulation, formulation, biopharmaceutics principles required to get a drug from discovery through clinical development is desirable.
- Strong scientific expertise, demonstrated by published scientific articles in peer-reviewed journals, society participation, regulatory filings and patents. Proficient in using computer to write and review technical reports and scientific judgment in data evaluation.
- Excellent communication skills, problem solving, critical thinking, and organization skills. Ability to work in a fast-paced organization with diverse project teams and personnel.
- Knowledge in pharmaceutical product development, CMC regulatory requirements, project management; and capability to collaborate with colleagues.
- EEO/AA M/F/V/D