Job Description
Role Overview:
You will be responsible for developing and validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids. This role involves using medium to complex analytical techniques and applying the assay for the analysis of drugs and metabolites in biological fluids.
Key Responsibilities:
- Follow established Apotex Research Pvt. Ltd. Bioequivalence Centres Standard Operating Procedures and adhere to regulatory guidelines such as DCGI, CDSCO, TPD, USFDA, TGA, ICH, GLP, and EMEA.
- Collaborate with the project lead for Bioanalytical method development, validation, and Routine batch sample analysis.
- Prepare project-specific solutions and sample preparations.
- Document all work and results as required.
- Verify and save acquired results in Chromatography Data acquisition systems.
- Conduct Laboratory Investigations when necessary.
- Operate general laboratory equipment and instrumentation systems.
- Maintain lab work area cleanliness.
- Work in a safe manner and collaborate as a team member.
- Demonstrate behaviors that reflect organizational values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence to all compliance programs, including Global Business Ethics, Compliance Program, Global Quality policies, Safety and Environment policies, and HR policies.
- Perform any other relevant duties as assigned.
Qualifications Required:
- Education: Minimum Bachelor's Degree in Pharmacy or Master's Degree in Science.
- Knowledge, Skills, and Abilities: Good understanding of GLP requirements, proficient in MS Office, strong communication skills, flexibility to work, drive projects related to Bioanalytical effectively.
- Experience: Minimum 2-4 years of experience in Bioanalytical.
About Apotex Inc.:
Apotex is a Canadian-based global health company that focuses on improving access to affordable innovative medicines and health products worldwide. With a diverse portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products, Apotex is a key player in the pharmaceutical industry. Headquartered in Toronto, Apotex has regional offices in the United States, Mexico, and India, making it the largest Canadian-based pharmaceutical company and a preferred health partner for the Americas in pharmaceutical licensing and product acquisitions. Apotex is committed to creating a welcoming and accessible work environment where everyone is valued, respected, and supported to succeed. Accommodations are available for applicants with disabilities during the recruitment process to ensure equal opportunities for all candidates. Role Overview:
You will be responsible for developing and validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids. This role involves using medium to complex analytical techniques and applying the assay for the analysis of drugs and metabolites in biological fluids.
Key Responsibilities:
- Follow established Apotex Research Pvt. Ltd. Bioequivalence Centres Standard Operating Procedures and adhere to regulatory guidelines such as DCGI, CDSCO, TPD, USFDA, TGA, ICH, GLP, and EMEA.
- Collaborate with the project lead for Bioanalytical method development, validation, and Routine batch sample analysis.
- Prepare project-specific solutions and sample preparations.
- Document all work and results as required.
- Verify and save acquired results in Chromatography Data acquisition systems.
- Conduct Laboratory Investigations when necessary.
- Operate general laboratory equipment and instrumentation systems.
- Maintain lab work area cleanliness.
- Work in a safe manner and collaborate as a team member.
- Demonstrate behaviors that reflect organizational values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence to all compliance programs, including Global Business Ethics, Compliance Program, Global Quality policies, Safety and Environment policies, and HR policies.
- Perform any other relevant duties as assigned.
Qualifications Required:
- Education: Minimum Bachelor's Degree in Pharmacy or Master's Degree in Science.
- Knowledge, Skills, and Abilities: Good understanding of GLP requirements, proficient in MS Office, strong communication skills, flexibility to work, drive projects related to Bioanalytical effectively.
- Experience: Minimum 2-4 years of experience in Bioanalytical.
About Apotex Inc.:
Apotex is a Canadian-based global health company that focuses on improving access to affordable innovative medicines and health products worldwide. With a diverse portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products, Apotex is a key player in the pharmaceutical industry. Headquartered in Toronto, Apotex has regional offices in the United States, Mexico, and India, making it the largest Canadian-based pharmaceutical company and a preferred health partner for the Americas in pharmaceutical licensing and product ac
About APOTEX
APOTEX
apotex.com
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