Beacon Pharmaceuticals Ltd.

Assistant Manager, R&D (Formulation)

General Info
  • Published on: Apr 30, 2022
  • Deadline: May 20, 2022
  • Source: Bdjobs.com
  • Vacancy: Unspecified
Job Details
  • Job Nature: Full-Time
  • Job Location: Beacon pharmaceuticals Plant, Bhaluka, Mymensingh
  • Salary: Attractive salary package will be given to deserving candidates
  • Job Context: To support and strengthen the existing team we are looking for smart, ambitious, energetic, intelligent and committed individuals for the position.
  • Job Description:
    • To ensure Product Development as per Regulatory Guidelines & QbD approach
    • To supervise Formulation development according to quality by design (QbD) concept including Product development plan, Pre-formulation study, Risk assessment of drug substance & drug product
    • To supervise Prototype, Pilot, R&D scale up Batch, PO, PV batch & ensure stability study as per regulatory guidelines
    • To supervise lab batch manufacturing of new & reformulated products for formulation & process optimization purposes, product/process improvement with aim to ensure quality product
    • To organize the submission of the relevant documents like recipe, stability data, annexure to the Drug administration
    • To develop new formulation comparing with innovator formulation in vivo & in vitro.
    • To organize & planning all formulation activities of R&D
    • To perform the development activities of new & reformulation of existing products as cost saving as well as improvement (problem solving) scheme in terms of stability & productivity
    • To perform pilot batch manufacturing for stability study purpose as per ICH Guidelines
    • Review Finished Products Specification, MFR, PV Protocol, Hold Time Study Protocol, Cleaning Validation, technology transfer of new products and regulatory documents
    • Review Packaging Material Specification compared with originator brand products, stability and production feasibility
    • Supervise to perform packaging material proof check, analysis- Artwork and PMS checking & analysis of Primary and Secondary Packaging Materials according to developed products
    • Review Raw materials & packaging materials requisition for lab and pilot batches as per product proposal and brief and for commercial batch manufacturing purposes as per sale forecast
    • Any other duties assigned by the reporting Superior
Job Requirements
  • Educational Requirements: M. Pharm from any reputed university.
  • Experience Requirements: 5 to 6 year(s)
  • Additional Requirements:
    • Should have well knowledge of Innovator, RLD, Reference product characterization & comparative study of drug product
    • Should have well knowledge of parenteral, Lyophilization etc. products
    • 5 to 6 years of working experience in Formulation development in a reputed pharmaceuticals company
Apply Procedure
  • Apply Instructions: Photograph must be enclosed with the resume.
  • Apply Link: Apply Online