Pharmaceutical Senior HPLC, GC/MS, and ICP-MS Analyst (Level III)

at  Shields Pharma Inc

ABOUT SHIELDS PHARMA INC.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.
We offer Laboratory R&D and QC testing services as well as production and formulation of certain psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and problematic substance.
Shields Pharma Inc. is an equal opportunity employer committed to diversity and inclusion for everyone. We are continuously looking for smart-minded, skilled, qualified, experienced, independent, reliable, and detail-oriented candidates to join our successful team.
Our people are at the heart of everything we do.

You can count on;

• Safety as our first core value,
• Integrity,
• Accountability, and
• Continuous Training and skill development.

Position Title: Pharmaceutical Senior HPLC, GC/MS, and ICP-MS Analyst (Level III)
Reports To: Chief Scientific Officer and Laboratory Manager

JOB DESCRIPTION:

The Senior HPLC, GC/MS, and ICP-MS Analysshallsupport both R&D and Quality Control analytical activities at Shields Pharma laboratory.
The Senior Analystis responsible for conducting method development and validation, method transfer, assay and impurity analysis by utilizing HPLC, LC/MS, GC-Headspace, GC/MS, and ICP-MS, projects according to the schedule established by following the procedures and adhering to Good Manufacturing Practices (GMP), GXP, and good laboratory practices.
The successful candidate will be working in a very fast paced environment, performing both R&D and QC analysis of assigned raw materials, in-process, and final products as per established methods, current pharmacopoeias (e.g. USP, BP, EP, etc.), and the client’s methods and specifications within standard time-lines, and under minimal guidance/supervision.
This position relies heavily on comprehensive wet chemistry and strong chromatographic skills and competencies.

Duties shall include but are not limited to the following:

• Perform all works in accordance with all established company policies, protocols and procedures, and governing regulatory, GMP compliance, and safety guidelines.
• Perform assay and impurities method development, method validation, method transfer, cleaning validation, and stability testing.
• Maintain accurate documentation including lab reports, records of procedures, results, and data analysis in accordance with Good Documentation Practices (GDP) guidelines
• Provide scientific advice and training to junior analysts on laboratory instrumentation and methods.
• Perform peer review of analytical reports and data when requested.
• Document and report results in accordance with GMP and GLP
• Conduct Laboratory Investigation (OOS, OOT, Deviation, etc.).
• Provide technical support to other analysts when required
• Collaborate with cross-functional teams to support R&D projects.
• Ensure all general lab supplies (chemicals/non-chemicals) are available at all time.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all analytical documentation including lab reports, records of procedures, results, and data analysis are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
• Provide oversight of external vendors who are delegated responsibilities when requested.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all generated documentation including lab reports, records of procedures, results, and data analysis are accurate and correct.

Job Requirements: (Work Status, Qualification, Knowledge, and Experience)

• Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.
• Must be living in Canada, preferably in Toronto area
• Minimum M.Sc. (min. 3 yrs. industry experience), or B.Sc. (min. 5 yrs. industry experience), preferably in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines.
• Must have worked minimum of 3 years (depending on the qualification) in pharmaceutical laboratory discipline.
• Must demonstrate solid technical knowledge and extensive expertise on operation, Qualification, trouble-shooting, and maintenance of sophisticated laboratory instrumentation and equipment including, LC/MS, UPLC, HPLC, GC-Headspace, GC/MS, and ICP-MS
• Must demonstrate expertise in analytical; method development, method validation, investigational studies, method transfer, stability studies, and preparation and execution of protocols, etc.
• Should be well versed in understanding of USP, BP, EP, and JP, methods and specifications.
• Must have in-depth knowledge and competency in cGMP/GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), GXP, FDA CFR 211, ICH, and ALCOLA+ regulation and quality system guidelines.
• Should be able to conduct laboratory investigation and other quality attributes (e.g. SOP development, Change Control, Deviation, Root Cause investigation and analysis, CAPA, TAR, etc.)
• Proficiency to MS office (Excel, Word, PowerPoint)
• Track record of multi-tasking, being detail-oriented, trouble-shooting/problem solving abilities, working in a fast-paced environment with minimal instruction on routine work and moderate instruction on new assignments.
• Be punctual, team player, fast learner, and have strong Interpersonal and communication skills,

• Perform all works in accordance with all established company policies, protocols and procedures, and governing regulatory, GMP compliance, and safety guidelines.
• Perform assay and impurities method development, method validation, method transfer, cleaning validation, and stability testing.
• Maintain accurate documentation including lab reports, records of procedures, results, and data analysis in accordance with Good Documentation Practices (GDP) guidelines
• Provide scientific advice and training to junior analysts on laboratory instrumentation and methods.
• Perform peer review of analytical reports and data when requested.
• Document and report results in accordance with GMP and GLP
• Conduct Laboratory Investigation (OOS, OOT, Deviation, etc.).
• Provide technical support to other analysts when required
• Collaborate with cross-functional teams to support R&D projects.
• Ensure all general lab supplies (chemicals/non-chemicals) are available at all time.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all analytical documentation including lab reports, records of procedures, results, and data analysis are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
• Provide oversight of external vendors who are delegated responsibilities when requested.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all generated documentation including lab reports, records of procedures, results, and data analysis are accurate and correct