Analytical R&D: Scientist/Senior Scientist/Principal Scientist
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 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 their disease and enhance quality of life.
About the Position:
The qualified candidate will take an active leadership role in supporting drug development by applying a variety of analytical methodologies to support physical and chemical characterization of drug substances (including raw materials and intermediates) and drug product. Working knowledge of analytical (e.g., HPLC-UV, HPLC-MS, GC-MS, SEC, spectroscopy) and physical chemical techniques (e.g., particle size, dissolution) used for the characterization of pharmaceutical substances and products and extensive GMP experience are desired.
The individual will be responsible for organizing studies in support of analytical testing of pharmaceutical projects, and relevant experience with the following analytical methodologies: chromatography, dissolution, KF, particle size will be desirable. Job responsibilities may include analytical method development and validation; stability and release testing; testing to support pharmaceutical development efforts; direct interaction with project team members, including presentation of data; critical review of data; preparation of technical reports; and evaluation of new instrumentation or analytical techniques. The candidate must be able to interact effectively with peers and leaders as part of a multi-disciplinary team and work in a fast-paced environment. Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.
The position requires a BS, MS, or Ph.D. in Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, or Pharmaceutical Sciences with at least 1-5 years working experience in pharmaceutical industry.
Expertise in pharmaceutical product development, project management, CMC regulatory requirements, and capability to collaborate with colleagues.
Strong technical skill in analytical method development, validation, and QC testing under cGMP environment.
Experience with a wide-variety of software and information systems (e.g. Empower, ChemStation, or LIMS).
Experience in problem-solving skills and instrument trouble-shooting.
Good oral and written communication skills and the ability to write and review technical reports and scientific papers are desired.