About Apotex Inc
Apotex Inc. Apotex is indeed a well-known Canadian pharmaceutical company that is dedicated to producing high-quality and affordable medicines for patients globally. With nearly 8,000 employees working in various aspects of the pharmaceutical industry, including manufacturing, research and development (R&D), and commercial operations, Apotex plays a significant role in the healthcare sector.
The company’s extensive global presence is noteworthy, with exports to over 100 countries and operations in more than 45 countries. Apotex has a strong presence in key regions, including Canada, the United States, Mexico, and India, which allows them to serve a diverse range of markets and provide access to their medicines on a wide scale. This global reach and commitment to affordable healthcare make Apotex an important player in the pharmaceutical industry.
Post: Lead Research Scientist, Analytical R&D
Job Description
Job Summary
- Method Development and Validation: Develop and validate analytical methods in compliance with relevant standards, SOPs, and GMP requirements.
- Sample Testing: Evaluate R&D samples for API supplier selection, specification development, and new product development.
- Scientific Support: Provide scientific support to Product Evaluation, Formulation, and Process Development.
- Complex Projects: Handle complex tasks and high-priority special projects.
- Problem Solving: Resolve day-to-day operational issues effectively.
- Collaboration: Collaborate with multidisciplinary teams to address complex product development challenges.
- Project Leadership: Lead assigned projects independently or as part of a team, ensuring timely completion.
- Data Review: Review laboratory data, instrument logbooks, and reports as necessary.
Job Responsibilities
- Project Planning: Prepare project plans and timelines, reporting to the Manager.
- Method Development: Develop stability-indicative analytical methods for drug substances and finished products.
- Problem Resolution: Identify and address analytical method issues.
- Quality Systems: Implement cGLP and departmental quality systems in Analytical Development.
- Validation: Lead analytical method validation activities, ensuring compliance with SOPs and guidelines.
- Verification: Verify and publish analytical methods and maintain validation documents.
- Testing: Conduct a range of analytical tests for drug substances, PE/PO samples, and API releasing.
- Investigations: Perform lab investigations for OOS and OOT results.
- Technology Transfer: Initiate, execute, and complete technology transfer and collaborative validation activities.
- Compliance: Ensure adherence to cGLP procedures and quality systems.
- Troubleshooting: Independently troubleshoot complex stability issues.
- Training: Participate in mandatory training to fulfill job responsibilities.
- Housekeeping: Assist with departmental housekeeping and other assigned duties.
- Collaboration: Foster strong relationships within Analytical R&D for on-time project delivery.
- cGMP Knowledge: Continuously upgrade knowledge of cGMP.
- Regulatory Compliance: Adhere to all established regulatory, compliance, safety, and quality requirements.
- Teamwork: Collaborate effectively with team members to achieve objectives.
- Values: Demonstrate organizational values: Collaboration, Courage, Perseverance, and Passion.
- Compliance: Adhere to all compliance programs, including ethical, quality, safety, and HR policies.
- Other Duties: Perform relevant assigned duties.
Candidate Profile
- Qualifications Required at Apotex Inc: Graduate/Postgraduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
- Instrumentation Knowledge: Proficiency with instruments such as HPLC, GC, UV, IR spectrophotometer, dissolution apparatus, and wet chemistry techniques.
- Method Expertise: Strong knowledge in HPLC method development and validation.
- Documentation: Ability to prepare and review various documents, including SOPs, formats, protocols, reports, and analytical data.
- Regulatory Understanding: Thorough understanding of regulatory guidelines and cGMP activities.
- Troubleshooting: Proficiency in instrument troubleshooting and analysis.
- Analytical Skills: Familiarity with wet chemistry, analytical bench techniques, software, and data acquisition systems.
- LIMS Knowledge: Working knowledge of Laboratory Information Management Systems is a plus.
- Communication: Good written and verbal English communication skills.
- Experience: Minimum 7-10 years of experience in method development and validation in the pharmaceutical industry.
- Analytical Chemistry: Extensive knowledge and experience in analytical chemistry.
Additional Information
- Experience Required at Apotex Inc: 7-10 years
- Qualification Required at Apotex Inc: M.Pharm, B.Pharm, M.Sc
- Location: Bangalore, KA
- Industry Type: Pharma/ Healthcare/ Clinical Research
- Functional Area: Analytical R&D
- End Date: 30th November, 2023
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