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.
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