Opportunity as Lead Research Scientist @ Apotex Inc- Apply before 30th November, 2023

Apotex Inc

Website Apotex Inc

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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To apply for this job please visit careers.apotex.com.