- Department Research & Development (R&D)
- Posted on 11 May 2022
- Deadline 31 May 2022
DBL Group is one of the most successful diversified corporate houses in Bangladesh. DBL Pharmaceuticals Limited, a DBL Group concern, has established a state-of-the-art manufacturing unit to conform international standards including WHO cGMP, UK MHRA, and USFDA to cater local market and global market as well, for high-end branded Generics. DBL Pharmaceuticals Ltd. is looking for talented and aspiring individual as Head of Research & Development (R&D).
- To lead and manage the complete range of R&D activities, both formulation development and analytical development functions.
- Drive product development from concept to final launch, including technical and process details.
- Familiar with analytical methods and instrumentation used to characterize APIs, excipients, primary packaging material and drug products.
- Track, analyze, and control costs, schedule, quality, towards achieving customer satisfaction.
- Coordinate with DRA for filing (e.g ANDAs) and addressing deficiencies; provide relevant documents to Regulatory Affairs unit in a timely manner for filings and supplements filing.
- Assure technology transfer to and from manufacturing site(s), following transfer norms, scale up batch production and handover.
- Plan and execute BE batch production for next level studies as relevant.
- Review of batch records, process characterization reports, validation reports and investigation reports.
- Create and review procedures, as well as review appropriate documentation and test results for accuracy and completeness and in compliance with SOPs/GMP requirements.
- Motivate, develop, and train scientists to reach desired product development goals meeting quality standards.
- Minimum M. Pharm from any reputed University.
- Must have a minimum of 15 years’ relevant experience
- Strong leadership and management abilities
- Generic Drug product R&D experience and successful track record of robust product launching.
- Extensive working knowledge of GxP practices, ICH guidelines, and other regulatory standards (e.g EMEA/USFDA).
- Good interpersonal and project management skills are critical for this position.
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