Senior Laboratory Analyst Level Iii
2 weeks ago
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: Senior Laboratory Analyst Level III (LC-MS/MS & GC-MS/MS SME)Reports To: Head of Laboratory OperationAbout the Role:Shields Pharma is seeking a Senior Laboratory Analyst with proven expertise in LC-MS/MS and GC-MS/MS, particularly in the analysis of nitrosamine impurities. The ideal candidate will provide analytical support to both R&D and Quality Control (QC) teams, ensuring full compliance with applicable regulatory guidelines and quality standards.The Senior Analyst will be responsible for method development, validation, transfer, and assay and impurity analysis utilizing a range of analytical techniques including HPLC, LC/MS, GC-Headspace, GC/MS, and ICP-MS. This role requires adherence to established procedures, project timelines, and Good Manufacturing Practices (GMP), GxP, and Good Laboratory Practices (GLP).This is a hands-on analytical position, ideal for a candidate passionate about working in a fast-paced pharmaceutical laboratory environment someone who thrives on solving analytical challenges and delivering high-quality data in support of drug development and manufacturing.Key Responsibilities: Perform analysis of nitrosamine impurities using LC-MS/MS and GC-MS/MS methods in APIs, excipients, and finished products. Operate, troubleshoot, and maintain analytical instrumentation, including HPLC, UPLC, GC-Headspace, GC-MS, LC-MS/MS, and ICP-MS. Sound knowledge of Nitrosamine analysis by LC/MS-MS and GC/MS Execute all work in accordance with company policies, protocols, procedures, and applicable GMP, regulatory, and safety guidelines. Conduct method development, validation, transfer, cleaning validation, and stability studies. Ensure full compliance with GMP, GxP, GDP, and safety requirements. Maintain accurate and compliant laboratory records in accordance with Good Documentation Practices (GDP). Support and participate in OOS, OOT, and deviation investigations, and prepare associated documentation (SOPs, CAPAs, etc.). Provide training and scientific guidance to junior analysts. Collaborate cross-functionally with R&D and QC teams to ensure timely project execution. Participate in regulatory inspections (e.g., Health Canada, FDA) and client audits. Maintain laboratory supply inventories and oversee vendor-related activities as required. Review peer analytical reports and data for accuracy, completeness, and compliance.Qualifications & Experience:Work Authorization: Must be a Canadian Citizen or Permanent Resident with valid work permit.Location: Must reside in Canada, preferably Toronto or surrounding areas.Education: M.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences (minimum 3 years of direct Canadian pharmaceutical experience), or B.Sc. in a related discipline (minimum 4 years of direct Canadian pharmaceutical experience)Technical Skills & Knowledge: Proven hands-on experience with LC-MS/MS, GC-MS/MS, HPLC, and ICP-MS. Strong background in nitrosamines risk assessment and testing. Proficient in method development, validation, stability testing, and instrument qualification. Knowledgeable in USP, BP, EP, JP pharmacopeial methods and specifications. Strong understanding of cGMP, GDP, GXP, ICH, FDA CFR 211, and ALCOA+ principles.Other Competencies: Excellent problem-solving and troubleshooting abilities. Effective communication and interpersonal skills. Demonstrated ability to multi-task, work independently, and perform under pressure. Proficient in MS Office applications (Excel, Word, PowerPoint).How To Apply:Please reference Senior Laboratory Analyst Level III (LC-MS/MS & GC-MS/MS SME) in subject line and submit resume with cover letter to We welcome and encourage applications from all qualified applicants. We are committed to adhering to our company objectives and requirements outlined above. Kindly refrain from applying if you are not qualified.We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.No phone calls please.
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