Formulation Development Executive (Senior specialist or Chief of department)

«ФАРМА ПЕРСОНАЛ»- спеціалізоване агентство

 Formulation Development Executive (Senior specialist or Chief of department)

 (LOCATION: TBILISI, GEO)

 FUNCTIONS: Responsible for development of oral solid dosage forms, literature search, pre-formulation, formulation design, and development of stable, bioequivalent and manufacturable generic solid oral formulations.

 RESPONSIBILITIES

• 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 Regulatory Affairs department 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. 
• Candidate must be a good mentor and motivator.

QUALIFICATIONS

• Candidate must have a minimum of 8 years in product development 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. 
• English language ability.

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