FORMULATION SCIENTIST/SR FORMULATION SCIENTIST
We have a need for two superb problem solvers with more than 4 years of experience in parental pharmaceutical formulation development.
THIS POSITION WILL:
Direct and participate in formulation studies to assess new product feasibility. Develop formulations and manufacturing processes for pilot and commercial batches. Support in the preparation of pharmaceutical development reports for regulatory submission.
Train, guide, and lead direct report scientist(s). Participate in goal setting, performance evaluations and development planning discussions.
Interact with other departments to disseminate strategy and provide details for defined studies. Operate with a high degree of independence within Product Development; however, will need to ensure senior management is intimately informed if significant timelines or problems arise during drug development.
As a contributing member of the Team, you will help define and implement strategy direction of product development. Development of technical skills to be able to develop sterile dosage forms beyond the traditional liquid and lyo formulations.
Collaborate with Quality Control, Microbiology, Validation, Manufacturing, and Regulatory Affairs department to coordinate pilot and registration batches.
Conducted analytical method development, validation, method transfer, and stability studies for raw materials and finished drug products.
Performed physical testing of APIs, excipients, and finished products using UV-Vis Spectrophotometer, FTIR, and HPLC techniques.
CANDIDATES MUST POSSESS:
- Excellent oral and written communication skills
- Ability to write scientifically sound protocols and reports for all development activities
- Proficient knowledge about FDA, USP, EP and ICH Regulatory Guidelines
- Skills working on diverse and complex parental and ophthalmic formulations, analytical techniques, and ANDA/NDA regulatory submissions
- Candidate is required to work under cGMP conditions and possess excellent laboratory practices
- Must be pro-active and capable of working independently and/or in a Team environment
THE FOLLOWING EXPERIENCE IS REQUIRED:
- Design, characterize, formulate, and transfer existing drug products (liquid, lyo, emulsion and suspension) to scale-up manufacturing
- Perform feasibility studies, method development, and method validation for various analytical instruments (e.g. HPLC, UV, and Particle Sizer)
- Compound lab batches and design accelerated stability studies to determine optimal drug products shelf life
- Manufacturing comprehension (i.e. aseptic techniques, equipment specifications, product filter requirements, etc.)
- Generated monographs, specifications, compounding records, and various technical protocols/reports including CMC sections for FDA submissions of drug products
UTILIZATION OF THE FOLLOWING INSTRUMENTATION IS PREFERRED:
- HPLC (Agilent and/or Waters, using Chromeleon and/or Millennium software systems)
- Particle Size analyzer
- Coulometer (% Water determination)
- Microscope (compound and/or freeze drying