Jenphar Bangladesh Limited is looking for Officer/Sr. Officer-Product Development (Formulation)

Job Context

• Jenphar Bangladesh Limited, an affiliate of Radiant Pharmaceuticals Limited started its journey on 13th July 2020. Jenphar has its legacy from Julphar Bangladesh Ltd. which was a subsidiary of Julphar UAE, one of the largest pharmaceutical manufacturers in the Middle East and Africa. The State-of-the art manufacturing facilities of Jenphar Bangladesh Limited has been engineered in order to comply international regulatory requirements like WHO-GMP, US-FDA & Australian-TGA guidelines.

Job Description / Responsibility

• Initiate new product (Oncology) and existing product development as per SOP.
• Conduct preformulation studies for new drug products with reference.
• Perform process optimization and validation batches during production.
• Prepare recipes and submit to Regulatory Affairs by compiling all data.
• Compile and submit annexures to Regulatory Affairs.
• Compile and submit DTL (Drug Master File) with samples to Regulatory Affairs.
• Prepare BOM/BMR/BPR/Validation protocol for scale-up batches.
• Conduct stability studies as per protocol and monitor products during the study.
• Develop packing material specifications based on the Product brief.
• Prepare protocols for process validation and compile validation reports.
• Fine-tune existing products as per proposal.
• Keep SAP-related data updated, including Master Data, BOM, Process order, Reservation, PR, GRN.
• Prepare SOPs and conduct training.
• Monitor PD RM & PM store (API, Excipient, PM) for requisition, preservation, and disposal.
• Coordinate with engineering for change parts requisition, maintenance, and calibration.
• Supervise PV batches and new source development as needed.
• Maintain and update the Process Validation database, PVP, PVR.

Educational Requirements

• Master of Pharmacy (M.Pharm)

Experience Requirements

• 3 to 5 year(s)

Additional Requirements

• Formulation Development
• Process Validation

Job Location

Gazipur (Sreepur)