Key Functions:

• Responsible for development of oral solid dosage forms of Non-DEA and DEA substances, Literature Search, Pre-Formulation, Formulation Design and Development of stable, Bioequivalent and Manufacturable generic solid oral formulations.

Responsibilities:

• Candidate must be a good mentor and motivator.
• Develop robust formulationsand processes for immediate release and modified release tablet and capsuledosage forms.
• Evaluate patents anddevelop non-infringement strategies. Capable of developing Paragraph IVproducts.
• Scale-up and optimizationof manufacturing process; execution of pre-exhibit and exhibit batches; scaleup and technology transfer from R&D to production to meet timelines.
• Plan and contribute toproject-related scientific/technical activities (e.g., interpret results,critical assessment of data, draw relevant conclusions, and write reports).
• Author technical documentsincluding Product Development Report, Quality Overall Summary and otherrelevant documents for regulatory filing purpose.
• Interaction with APImanufacturers, CROs and CMOs as needed.
• Work proactively with othercross-functional groups to execute change controls associated withManufacturing and Packaging master records, SOPs and protocols.
• Create and review SOPs, aswell as review appropriate documentation and test results for accuracy andcompleteness and compliance with SOPs/GMP requirement.
• Coordinate with RA forfiling ANDAs and addressing deficiencies; provide relevant documents toRegulatory Affairs in a timely manner for ANDA filings and Supplements filing.
• Review of batch records,process characterization reports, validation reports and investigation reports.

Required Educational Qualification and Relevant Experience:

• Master’s with a minimum of10 years or a Ph.D. degree in Pharmacy with a minimum of 5 years of relevantexperience in oral solids product development in generic pharmaceuticalindustry. Generic R&D experience and successful track record of ANDsubmissions is a must. Experience with modified release dosage forms is aplus.  Candidates must be self motivated with excellent written and verbalcommunication skills. Good interpersonal and project management skills arecritical for this position.