Job Description
Title: Senior Officer/ Assistant Manager - R & D (Analytical/Formulation)
Company Name: Dider Pharma Limited
Vacancy: Not specific
Job Location: Bogura
Employment Status: Full-time
Educational Requirements:
∎ Master of Pharmacy (M.Pharm)
∎ The candidate should be an M.Pharm / B.Pharm with a thesis in relevant R&D work.
Experience Requirements:
∎ 5 to 7 year(s)
∎ The applicants should have experience in the following area(s):
Pharmaceuticals, Pharmacist
Job Responsibilities:
∎ To Execute Analytical Method Development activities of drug products under
∎ development, based on QbD principles and regulatory requirements.
∎ Execution of Analytical Method validation activities for drug products as per the
∎ regulatory requirements.
∎ Execute routine Analytical Research activities of drug products.
∎ Establishing In-house systems and procedures to ensure cGLP practices &
∎ regulatory requirements for analytical activities at in-house R & D Facilities.
∎ Profile Description & Ability:
∎ Strong conceptual, analytical development and validation skills.
∎ Good communication (verbal, writing) and presentation skills.
∎ Must have ability to work under pressure, meet deadlines, and work on multiple
∎ projects simultaneously.
∎ Must be a team player and be able to interact with staff at all levels of the
∎ company and with external parties as well.
∎ Must have ability to work independently.
∎ Adequate Job knowledge and exposure to different Analytical methods and
∎ instrumentations.
∎ Adequate Job knowledge and exposure to QbD, DoE and statistical
∎ interpretation etc.,
∎ Trouble shooting related to Testing methods, Stability studies, test results and
∎ designing of additional
∎ experimentations as necessary
∎ Execution & coordination for Analytical method transfer activities of drug
∎ products.
∎ Calibration of the Analytical instruments as per the master calibration schedule.
∎ Technical assessment & Analysis of drug substances (API) for projects execution.
∎ Review & clearance of technical documents leading to dossier batches
∎ executions and registrations.
∎ Preparation and review of Specifications, Method of analysis procedures and
∎ Analytical development
∎ reports.
∎ Preparation and review of analytical protocols and reports (Analytical method
∎ validation, Method
∎ feasibility, Analytical method transfer, etc.).
∎ Technical assessments of projects (Screening, pipeline and development projects
∎ stages) & Literature
∎ search).
∎ Preparation of analytical technical documents for dossier / Technology transfer
∎ executions / Regulatory
∎ submissions of projects.
∎ Assisting and resolving technical queries raised during Technology transfer
∎ activities & regulatory .
∎ submissions.
∎ Assisting in establishment of In-house Infrastructure (Analytical equipment's
∎ Qualifications and preparation of SOP's).
∎ Assessment & coordination on regulatory deficiencies.
∎ Assisting with analytical requirements in finalization of project costings.
Additional Requirements:
∎ Age 25 to 35 years
∎ Both males and females are allowed to apply
∎ Candidates who are applying for the senior officer post should have working experience as officer at least 03 years.
∎ Candidates who are applying for the Assistant Manager post should have working experience as senior officer at least 03 years.
Salary: Negotiable
Compensation & Other Benefits:
∎ Salary Review: Yearly
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 6 Jan 2024
Company Information:
∎ 7 Dec 2023
∎ Dider Pharma Limited
∎ Address : Kukrul, Darial Road, Hazradighi, Bogura
Category: Medical/Pharma
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