Research and Development Formulation Manager

SUMMARY:

Manager, Formulation R&D is responsible for pharmaceutical product development and associated activities. This position is responsible for working with cross-functional departments such as Manufacturing, QA, QC, AR&D, Regulatory Affairs, and Portfolio Management. Manager provides required documentation to RA in a timely manner to support ANDA filings and supplement filings as needed. Job entails developing robust products and processes that are scalable, stable and bioequivalent to the Reference Product. This is a leadership position that requires the candidate to be conversant with current practices and trends within FDA and industry to meet compliance and keep up with technology. Candidate should develop and motivate staff to their full potential.

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.

MINIMUM QUALIFICATIONS:

Candidate must have a MS 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.