Executive – Analytical Research & Development (R&D) | Method Development & Validation
Location: Bangalore, Karnataka, India
Company: Apotex
Employment Type: Full-Time
Job Overview
Apotex is seeking a highly skilled Executive – Analytical Research & Development (R&D) to support method development, validation, and analytical lifecycle management within a GMP-regulated pharmaceutical environment. This role is critical in ensuring the development and validation of robust analytical methods aligned with global regulatory standards. The ideal candidate will contribute to regulatory submissions, method transfers, and continuous improvement of analytical processes.
Key Responsibilities
Analytical Method Development & Validation
Execute analytical method development and optimization for pharmaceutical products
Perform method validation and verification for in-house, compendial, and transferred methods
Support Method Life Cycle Management (MLCM) and Supplier Driven Changes (SDC) activities
Conduct cleaning method validation and analytical studies as per regulatory guidelines
Method Transfer & Documentation
Prepare and review method validation, verification, and transfer protocols and reports
Execute method transfer activities, including analysis and reporting
Ensure accurate and compliant documentation aligned with regulatory expectations
Regulatory Support & Compliance
Perform analytical studies to support regulatory submissions and queries
Ensure all laboratory activities comply with cGLP, GMP, and global quality standards
Maintain adherence to safety, environmental, and compliance policies
Quality Control & Laboratory Operations
Support Quality Control laboratory activities, ensuring proper documentation and system implementation
Perform multi-parameter analysis using HPLC and other analytical instruments
Collaborate with cross-functional teams to meet project timelines and deliverables
Collaboration & Continuous Improvement
Work effectively within teams to achieve project goals and timelines
Demonstrate organizational values including collaboration, accountability, and innovation
Participate in process improvements and quality system enhancements
Required Qualifications
Master’s degree (MSc) in Chemistry/Analytical Chemistry or Bachelor’s degree in Pharmacy (B.Pharm) or equivalent
Strong knowledge of analytical method development and validation techniques
Proficiency in Microsoft Office tools (Word, Excel)
Hands-on experience with HPLC and analytical instrumentation
Understanding of GMP, cGLP, and regulatory compliance standards
Experience Required
3 to 6 years of experience in Analytical R&D within a GMP-regulated pharmaceutical industry
Proven experience in method development, validation, and transfer activities
Experience supporting regulatory submissions and analytical investigations
Key Skills
Analytical Method Development & Validation
HPLC & Instrumental Analysis
GMP & cGLP Compliance
Method Transfer & Documentation
Regulatory Submissions Support
Data Analysis & Problem-Solving
Attention to Detail & Time Management
Why Join Apotex?
Work with a globally recognized pharmaceutical company committed to innovation and accessibility
Exposure to advanced analytical technologies and regulatory environments
Inclusive and collaborative workplace culture
Opportunities for professional growth and development
About Apotex
Apotex is a Canadian-based global pharmaceutical company dedicated to improving access to affordable and innovative medicines worldwide. With a diverse portfolio including generics, biosimilars, and branded products, Apotex operates across multiple regions including North America, Asia, and Latin America, delivering high-quality healthcare solutions globally.
How to Apply
Interested candidates can apply through Apotex’s official careers portal or submit their updated resume via ThePharmaDaily.com to explore opportunities in analytical research and pharmaceutical development.
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