Head of Research & Development (R&D)

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).

Job Responsibilities:

1. To lead and manage the complete range of R&D activities, both formulation development and analytical development functions.
2. Drive product development from concept to final launch, including technical and process details.
3. Familiar with analytical methods and instrumentation used to characterize APIs, excipients, primary packaging material and drug products.
4. Track, analyze, and control costs, schedule, quality, towards achieving customer satisfaction.
5. 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.
6. Assure technology transfer to and from manufacturing site(s), following transfer norms, scale up batch production and handover.
7. Plan and execute BE batch production for next level studies as relevant.
8. Review of batch records, process characterization reports, validation reports and investigation reports.
9. Create and review procedures, as well as review appropriate documentation and test results for accuracy and completeness and in compliance with SOPs/GMP requirements.
10. Motivate, develop, and train scientists to reach desired product development goals meeting quality standards.

Educational Requirements:

• Minimum M. Pharm from any reputed University.

Experience Requirements:

• Must have a minimum of 15 years’ relevant experience

Additional Requirements:

• 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.