Scientist, Formulation Development

Job Description Scientist, Formulation Development JOB SUMMARY REPORTING RELATIONSHIPS This role reports to the V.P. RD Orals This role has no direct reports DUTIES & ESSENTIAL JOB FUNCTIONS · Formulator with previous industrial experience developing and filing generic drug dosage forms (orals/liquids) ·

• Ability to perform extensive Literature Search on assigned Projects. · Thorough understanding of the ANDA (and preferably NDA) filing process in line with QbD elements in generic product development ·
• Experience working with projects from bench-top stage to large scale manufacture of submission batches · Should have a sound knowledge of pharmaceutics, pharmacokinetics and process scale-up OTHER FUNCTIONS AND RESPONSIBILITIES Suggest improvements and efficiencies in the department.
• Assist in revising and maintaining SOPs, operating procedures and other documents. Suggest new equipment and or training for personnel. QUALIFICATIONS Formulation development and process development scientist with 3+ years of experience in the generic drug industry with ANDA filing experience. REQUIRED
• MS or PhD in Pharmaceutics or related field PREFERRED
• Experience in working with DEA controlled drug substances and relevant regulations.
• Experience in developing controlled-release product using Fluid Bed Processor (Wurster coating) technology. Quick Checklist

Qualifications

Candidates will need to have all of the requirements on the job description especially this part: Formulation development and process development scientist with 3 or more years of experience in the generic drug industry with ANDA filing experience. Must have ability to work in a team with excellent spoken and written communication skills Candidates would definitely need Formulation Development and Process Development background. Both are a must.

Additional Information All your information will be kept confidential according to EEO guidelines.