Title: Sr. Manager/ Assistant General Manager, R&D
Company Name: The IBN SINA Pharmaceutical Industry PLC
Vacancy: --
Age: Na
Job Location: Gazipur
Salary: Negotiable
Experience:
Published: 2026-02-09
Application Deadline: 2026-02-19
Education:
Requirements:
Skills Required:
Additional Requirements:
Responsibilities & Context:
Establishment, implementation and maintenance of analytical development systems in alignment with EU GMP & PIC/S.
Development, optimization and lifecycle management of analytical methods for APIs intermediates and finished products.
Planning, execution and approval of analytical method validation, verification and robustness studies.
Analytical support for technology transfer, process validation and commercial manufacturing.
Scientific evaluation & investigation support for OOS, OOT, deviation and root cause analysis.
Ensuring compliance with data integrity principles (ALCO+) in analytical development activities.
Preparation, review and approval of AR&D protocols, reports, specification and related documentation.
Collaboration with QA,QC Regulatory Affairs, and MS&T for regulatory submission and responses.
Ensuring appropriate training, qualification and GMP awareness of AR&D personnel.
Support to internal audits, self-inspection, and regulatory inspections related to analytical development activities.
As per company rules.