Title: Assistant Manager/ Manager – Product Development (R & D)
Company Name: Astra Biopharmaceuticals Ltd.
Vacancy: --
Age: At least 32 years
Job Location: Dhaka (Savar)
Salary: --
Experience:
M.Pharm from a reputed and recognized university.
Candidates having specialization in Pharmaceutics / Pharmaceutical Sciences will get preference.
Strong knowledge of pharmaceutical formulation and product development processes.
Good knowledge of cGMP, GLP, ICH guidelines and pharmaceutical regulatory requirements.
Strong leadership, analytical and problem-solving skills.
Excellent project management and team management capability.
Good documentation and report-writing skills.
Experience
8 to 10 years of relevant experience in Pharmaceutical Product Development / R&D.
Candidates with experience in formulation development, scale-up and technology transfer will be preferred.
Experience in a managerial/team-lead position will be an added advantage.
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.
Attractive salary package based on qualification and experience.
Festival Bonus.
Annual increment as per company policy.
Other benefits as per company policy.