Head of R&D
Job Description
Title: Head of R&D
Company Name: BEACON Pharmaceuticals Ltd.
Vacancy: Not specific
Job Location: Mymensingh
Employment Status: Full-time
Educational Requirements:
∎ M.Pharm/M.Sc in Chemistry from any reputed University at home or abroad.
Experience Requirements:
∎ At least 20 year(s)
Job Responsibilities:
∎ Leading the R&D team to achieve the business objective of the organization by providing necessary guidance to develop generic drugs for domestic and regulated markets.
∎ Supervising the R&D team by organizing workflow and tasks to maximize operational efficiency of both formulation and analytical lab and rearranging the resource based on the requirements to meet organizational objectives.
∎ Working in close coordination with Higher Management, Marketing, and Business
∎ Development teams for the selection of product portfolio and timeline settings.
∎ Facilitating and ensuring formulation development encompassing the QbD principles like DoE, and FMEA in (Solid & liquid orals) In-house and In-licensing projects.
∎ Evaluating the proposal of new project feasibility in accordance with existing equipment & facility in the scope of R&D & production facility.
∎ Developing a Quality Target Product Profile based on knowledge gained from literature search and Reference Product characterization as per the given product development timelines.
∎ Supervising clinical affairs, development quality assurance, and Technology transfer department. Drive product development from concept to final launch.
∎ Coordinating the Analytical department for the generation, compilation, evaluation, and interpretation of analytical data during product development.
∎ Providing technical expertise and interface on all project activities like licensing, pre-formulation studies, strategy design, formulation development, bio-equivalence study, manufacturing process development, technology transfer, and validation.
∎ Supervising the buildup of the regulatory dossier for submission, addressing regulatory queries, and supporting the commercial launch.
∎ Participating in process improvement activities to reduce development timelines, improve production efficiency and improve the quality of submissions.
∎ Anticipating the market demand, planning, and developing products to meet consumer needs and remain competitive in the marketplace
∎ Review of project-related documents, protocols, reports, and records.
Additional Requirements:
∎ Minimum 20 years of experience in a similar work field.
∎ Expertise in developing formulations and scaling up for the following class of
∎ drugs:
∎ Potent (Oncology, Immunosuppressant, Steroids) low-dose small molecules
∎ Non-potent (IR, DR, ER, Pellets, MUPS, liquids, derma, and other technologies)
∎ Large molecules: Scale up (Proteins and Peptides)
∎ Fermentation-based API dosage form development
∎ Insightful knowledge of USP, NF, BP, IP, cGMP, cGLP, SOPs, ICH guidelines, FDA regulations, ANDA, NDA, 505(b)2, OTC monographs,
Salary: Negotiable
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 23 Oct 2022
Company Information:
∎ 18 Oct 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
: ONLY NON-SMOKERS CAN APPLY
