Pharmaceutical Sciences Job at Apotex
Are you aiming for a high-impact pharmaceutical sciences job in a global pharma company? This is an exciting opportunity for life science graduates to join Apotex as a Research Scientist in Analytical Development. If you have a passion for drug development, analytical techniques, and regulatory science, this role offers a strong platform to grow in pharmaceutical R&D.
About Apotex
Apotex Inc. is a Canadian-based global health company focused on improving access to affordable and innovative medicines. With a diverse portfolio including generics, biosimilars, and branded pharmaceuticals, the company operates worldwide with headquarters in Toronto and a strong presence across the Americas and India.
Job Details:
- Job Title: Research Scientist – Analytical Development
- Location: Bangalore, Karnataka, India (560099)
- Company: Apotex Inc.
Role Overview
The Research Scientist – Analytical Development is responsible for planning and executing analytical method development and validation for pharmaceutical products. The role involves comprehensive testing of APIs and finished dosage forms, ensuring compliance with regulatory, quality, and safety standards.
Key Responsibilities
- Plan and execute analytical method development and validation for new products
- Perform testing of APIs and finished dosage forms in compliance with regulatory standards
- Review laboratory data, instrument logs, and analytical reports
- Initiate and track Change Control Requests (CCR) through QMS systems
- Prepare Transfer of Analytical Procedures (TAP) protocols and reports for site transfers
- Manage procurement of samples and impurities for analytical studies
- Maintain and archive regulatory documentation including SOPs, protocols, and reports
- Develop stability-indicating analytical methods for drug substances and products
- Ensure compliance with cGLP, cGMP, and departmental quality systems
- Prepare and execute validation protocols and generate reports
- Perform analytical testing including assay, related substances, dissolution, and wet chemistry
- Conduct testing for API release and dosage submissions
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results
- Raise and manage change controls for analytical activities via QMS
- Prepare SOPs related to general, operational, and calibration procedures
- Support technology transfer and collaborative validation activities
- Troubleshoot complex analytical and stability-related issues
- Maintain laboratory instruments and ensure proper functioning
- Participate in training programs and maintain compliance with company policies
- Collaborate with cross-functional teams to ensure timely project delivery
- Adhere to safety, regulatory, and quality compliance standards
Educational Qualification
Graduate or Postgraduate degree in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or related field
Experience
- B.Sc. with 5 years OR M.Sc. with 3–4 years of experience in a pharmaceutical R&D laboratory
- Experience in chromatographic method development and validation
Required Knowledge & Skills
- Expertise in analytical instruments such as HPLC, GC, spectrophotometer, and dissolution apparatus
- Strong knowledge of HPLC method development and validation
- Understanding of cGMP, regulatory guidelines, and quality systems
- Experience in preparing and reviewing SOPs, protocols, and analytical reports
- Knowledge of wet chemistry and analytical bench techniques
- Familiarity with LIMS (preferred)
- Troubleshooting skills for analytical instruments and methods
- Proficiency in computer-based systems and data acquisition tools
- Strong written and verbal communication skills
Core Competencies
- Attention to detail and accuracy
- Strong analytical and problem-solving abilities
- Team collaboration and communication
- Ability to manage multiple projects and timelines
- Commitment to quality, compliance, and continuous improvement
Work Environment
- Pharmaceutical R&D laboratory setting
- Compliance-driven and quality-focused environment
- Collaborative team structure with cross-functional interactions
