Job Description
Title: Head of R&D
Company Name: Beacon Pharmaceuticals PLC
Vacancy: --
Location: Mymensingh (Bhaluka)
Salary: Negotiable
Experience:
∎ At least 20 years
Published: 27 Jan 2025
Education:
∎ Masters
∎ M.Pharm/ M.Sc in Chemistry from any reputed University at home or abroad.
Requirements:
Additional Requirements:
∎ 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,
∎ 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,
∎ Minimum 20 years of experience in a similar work field.
Responsibilities & Context:
∎ 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.
∎ BEACON is one of the fastest growing pharmaceutical companies of Bangladesh. After the success in local market, Beacon is the most popular Bangladeshi company in global market for its high-tech oncology & hepatitis products.
∎ BEACON Pharmaceuticals PLC is a vision-driven company and designed to conform to the Global standards like US FDA, UK MHRA, TGA Australia, WHO cGMP and has set up the dedicated oncology plant in Bangladesh with isolator technology to manufacture anticancer drugs. To support and strengthen our existing team we are looking for smart, ambitious, energetic, intelligent and committed individuals for the mentioned position.
∎ Job Description:
∎ 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.
Skills & Expertise:
Employment Status: Full Time
Job Location: Mymensingh (Bhaluka)
Company Information:
∎ Beacon Pharmaceuticals PLC
∎ 9/B/2, Toyenbee Circular Road, Motijheel, Dhaka
Address::
∎ 9/B/2, Toyenbee Circular Road, Motijheel, Dhaka
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 6 Feb 2025
Category: Others
