Assistant Manager/ Manager - Product Development (R & D)

Job Context

Astra Biopharmaceuticals Ltd. is looking for a competent, dynamic and experienced professional for the position of Manager – Product Development to lead pharmaceutical formulation development, scale-up, technology transfer and related R&D activities.

Job Location: Factory (Gouripur, Ashulia, Savar, Dhaka)

Job Responsibilities

• Lead and manage pharmaceutical product development projects from product concept to commercialization.
• Perform stability study sample management (receiving/withdrawal). Compile stability study sample analysis report on regular basis and convey it to Head of Plant.
• Responsible to generate all documents of PD department like product specification, raw material specification, Recipe and Annexure, DGDA dossier to submit in regularity office.
• Develop, optimize and validate pharmaceutical formulations as per project requirements.
• Conduct pre-formulation and formulation development studies.
• Coordinate product development activities with QA, QC, Production, Regulatory Affairs, Engineering and Supply Chain departments.
• Prepare, review and maintain product development protocols, reports, specifications, BMRs/BPRs and other technical documents.
• Review and evaluate raw materials, active pharmaceutical ingredients (API), excipients and packaging materials for product development.
• Investigate formulation and process-related problems and recommend appropriate corrective actions.
• Ensure compliance with cGMP, company SOPs and applicable regulatory requirements.
• Prepare periodic project status reports and present development progress to management.