Assistant Manager, R&D (Formulation)
Job Description
Title: Assistant Manager, R&D (Formulation)
Company Name: BEACON Pharmaceuticals Ltd.
Vacancy: Not specific
Job Location: Mymensingh
Employment Status: Full-time
Educational Requirements:
∎ M. Pharm from any reputed university
Experience Requirements:
∎ 5 to 6 year(s)
Job Context:
∎ To support and strengthen our existing team we are looking for smart, ambitious, energetic, intelligent and committed individuals for the position:
∎ Job Location: Beacon pharmaceuticals Plant, Bhaluka, Mymensingh
Job Responsibilities:
∎ 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
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
Salary:
∎ Attractive salary package will be given to deserving candidates
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 20 May 2022
Company Information:
∎ 30 Apr 2022
∎ BEACON Pharmaceuticals Ltd.
∎ Business : BEACON Pharmaceuticals Limited is a vision-driven company and designed to conform to the world standards like FDA-USA, MHRA-UK, TGA-Australia and cGMP-WHO and has set up the only dedicated oncology plant in Bangladesh with isolator technology to manufacture anticancer drugs. We are truly a professional organization and believe in the strength of people who can make the difference.
Category: Medical/Pharma
: Interested candidates are requested to
