Friday, 20 April 2018

HEAD - Formulation Research & Development (injectables) at Hyderabad

Company name : etico lifesciences- Hyderabad
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Job Summary
  • Responsible for ideation, review of literature, Patent search, conceptualization, strategization, experimental designing and supervision of entire developmental activities for all Regulated markets.
  • Supervising the development of new product development (Parenterals) by complying GLP procedures and ICH guidelines.
  • Planning for scale-up and optimization of manufacturing process; pre-exhibit and exhibit batches; scale up and technology transfer from RD to production to meet established project goals and timelines.
  • Familiarity with QBD project management methodology, demonstrated ability to lead project teams and scientists.
  • Plan and contribute to project-related scientific/technical activities as per current FDA/EU requirement.
  • Writes protocols or propose specifications based on USP, ICH or other compendial or regulatory requirements.
  • Understanding and support to design Bio studies to justify bio equivalence between generic and R&D formulation where ever applicable.
  • Review of technical documents including product development report, quality overall summary and other relevant documents for regulatory filing purpose.
  • Review of LNBs, stability protocol, stability report, process validation protocol, process validation report, investigation reports, process characterization reports, process optimization protocol, process optimization reports and relevant departmental documents.
  • Review of SOPs, as well as review appropriate documentation, test results for accuracy, completeness and compliance with SOPs/GMP requirement.
  • Guiding and assigning the team to perform various lab batches, optimization batches, scale up batches and existing commercial batches for troubleshoots.
  • Selecting potential vendor for API and Excipients with respect to quality and cost effectiveness.
  • Interaction with CROs and CMOs as needed.
  • Coordinate with Regulatory affairs team for filing dossiers and addressing deficiencies; provide relevant documents to Regulatory Affairs in a timely manner for dossiers filings, amendments, supplements filing.
Salary: Best in the Industry
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category: R&D
Role: Formulation Scientist
Employment Type: Permanent Job, Full Time
Education-
UG: B.Pharma - Pharmacy
PG: M.Pharma - Pharmacy
Doctorate: Doctorate Not Required
Job Type: Full-time
Click here to apply online