Lead Research Scientist Bioanalytical Analysis Support
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Job Summary
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
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- Under supervision of reporting manager responsible for developing validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applies assay for the analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques. Responsible for interpreting data and completing the required reports and documentation
- Conducts duties following established Apotex Research Pvt. Ltd. Bioequivalence Centres Standard Operating Procedures and in a consistent manner with current regulatory ( DCGI- CDSCOTPD USFDA TGA ICH GLP EMEA) guidelines / established practices / expectations.
- To work with the assigned project lead for Bioanalytical method development Bioanalyitcal Method validation and Routine batch sample analysis (RBSA).
- Involves in preparation of project specific solutions and sample preparation.
- Documents all the work and results of all assignments as required.
- Verifies and saves acquired results in Chromatography Data acquisition systems.
- Creates sample sequences in Watson LIMS.
- Performs Incurred sample reanalysis (ISR) selection when required.
- Performs Laboratory Investigation and as required involves in Laboratory Investigation Report (LIR) preparation.
- Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems.
- Assists in the preparation of Bioanalytical reports.
- Performs raw data compilation assists in project wrap-up and archiving after completion of final reports.
- Involves in troubleshooting of analytical instruments and addresses procedural concerns if necessary in consultation with reporting Manager
- Sets-up and ensures calibration of analytical systems and maintains instrument systems in good working order.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration Courage Perseverance and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program Global Quality policies and procedures Safety and Environment policies and HR policies.
- All other relevant duties as assigned.
- Education
- Minimum Bachelor Degree holder in Pharmacy or Masters Degree in Science.
- Knowledge Skills and Abilities
- Good knowledge of GLP requirements.
- Good skills in MS Office.
- Good in Communication skills.
- Flexible to work
- Strives to drive projects related to Bioanalytical effectively.
- Experience
- Minimum 7-9 years of experience in Bioanalytical.
- Minimum 7-9 years of experience in Bioanalytical.
At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.
Required Experience:
IC
About Company
Apotex is the largest Canadian-owned pharmaceutical company providing patients around the globe with quality, affordable medicines. We are an innovative global research and technology leader in generic pharmaceuticals that serves customers and partners in the U.S. market, as well as 1 ... View more
