Sr. Scientist Formulation
Job Description
This is a Formulation Scientist role in Generic Pharma. This role is very hands-on
• Formulator with previous industrial experience developing generic Oral Solid Dosage Forms (including Oral Liquids preferred)
• Ability to perform extensive Literature Search on assigned Projects
• Ability to develop non-infringing formulations
• Familiar with adapting 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
• Plan, design and execute experiments for product development
• Analyze data and summarize in form of reports
• Review literature, reports, protocols etc.
• Discuss, prioritize and plan work with external functions such as ARD, TS & Manufacturing
• Provide feedback to senior management on project progress
• 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.
• Formulation and process development scientist with 3 - 5 years of experience in the generic drug industry
• Must have ability to work in a team with excellent spoken and written communication skills
• MS or PhD in Pharmaceutics
• Must have experience in developing oral solid dosage forms from Bench Scale all the way to large scale submission batch manufacture, at other generic Pharma companies
• Experience in working with DEA controlled drug substances and relevant regulations..
Skilled in Formulation Product Development
Generic Drug
ANDA submissions
Generic Drug Development