Scientific Manager - Formulations R&D

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 formulations and processes for immediate release and modified release tablet and capsule dosage forms.
• Evaluate patents and develop non-infringement strategies. Capable of developing Paragraph IV products.
• Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet timelines.
• Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports).
• Author technical documents including Product Development Report, Quality Overall Summary and other relevant documents for regulatory filing purpose.
• Interaction with API manufacturers, CROs and CMOs as needed.
• Work proactively with other cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs and protocols.
• Create and review SOPs, as well as review appropriate documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement.
• Coordinate with RA for filing ANDAs and addressing deficiencies; provide relevant documents to Regulatory 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 of 10 years or a Ph.D. degree in Pharmacy with a minimum of 5 years of relevant experience in oral solids product development in generic pharmaceutical industry. Generic R&D experience and successful track record of AND submissions is a must. Experience with modified release dosage forms is a plus.  Candidates must be self motivated with excellent written and verbal communication skills. Good interpersonal and project management skills are critical for this position.