Position Title: Senior Laboratory R&D and QC Analyst (Level III)

Reports To: Chief Scientific Officer and Laboratory Manager

Job Description:

The Senior Laboratory R&D and QC Analyst supports both R&D and Quality Control analytical activities at Shields Pharma laboratory.

The Senior Laboratory R&D and QC Analyst is responsible for conducting method development and validation, method transfer, assay and impurity analysis by utilizing HPLC, LC/MS, UPLC, GC-Headspace, GC/MS, ICP-MS, and Dissolution instrumentation 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
• Maintain professional relationship with Internal/External Customers
• 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.
• Ensure the laboratory is clean in an orderly manner 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 analysts 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).

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 5 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, ICP-MS, and dissolution.
• Must demonstrate expertise in analytical; method development, method validation, investigational studies, method transfer, stability studies, and preparation and execution of protocols,
• 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) is a must
• 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.

How To Apply:

Please reference “Senior Laboratory R&D and QC Analyst (Level III)” in subject line and submit resume with cover letter to mmassoudinia@shieldspharma.com

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.

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 it is our first core value,
• Integrity,
• Accountability, and
• Continuous Training and skill development.

We are currently looking for the following  individuals to join our growing team!

Position Title: Metrology Specialist (Full-time)

Reports To: Head of Operation & Laboratory Manager

Job Description:

This is a technical position involving qualification, calibration, preventative maintenance, and repairs of the of laboratory and facility instrumentation and equipment in accordance to Shields Pharma Inc. applicable SOPs and policies, GXP, ICH, GAMP, FDA CFR 211, ALCOLA+ , and other regulatory guidelines and requirements.

Duties and responsibilities include, but are not limited, to the following:

• Performing Shields Pharma instrument and equipment IQ, OQ, PQ qualification and Calibration activities.
• Performing preventive maintenance and troubleshooting of laboratory and facility equipment and instrumentation, and control systems.
• Following company’s written procedures
• Preparing technical SOPs.
• Executing Repairs and accurately documenting repair activities.
• Assessing instrument failures/breakdowns, systematically identifying problems, and restoring to operation
• Review and update calibration procedures based on field experience.
• Supporting, overseeing, and supervising contractors/services providers performing tasks within the company and ensuring the external contractor/s are adhering to the company safety requirements and cGMP standards.
• Identifying opportunities for improving Shields Pharma metrology programs.
• Preparing accurate and comprehensive qualification and calibration protocols and reports in accordance to the company policies, procedures, GDP, and cGMP.
• Completing calibration, PM, and repair documentation accurately and comprehensively including work orders and logbooks in accordance to Shields Pharma policies and procedures, ALCOLA+, FDA CFR 211, and others.
• Ensure equipment/instrument qualifications, calibrations, repairs and maintenance documentations are up-to-date and archived.  
• Create and/or revise calibration and operation procedure/s.
• Support Quality Assurance investigations of instrument failures/breakdowns.
• Perform any other tasks/duties as assigned by departmental management.

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

• Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.
• Must be living in Canada, preferably in Toronto area
• Minimum Science degree in Chemistry, Analytical Chemistry, Mechanical/electronic Engineering, or similar applied scientific disciplines.
• Minimum of 3 – 4 years of direct and hands-on experience working experience in equipment and instrumentation, qualification, calibration, PM, trouble shooting, and repairs  in pharmaceutical laboratory and production environment.
• Familiar with a variety of hand tools, electric meters, calibration standards to perform essential day-to-day duties.
• Experience working in a Pharmaceutical or similar regulated industry preferred.
• Must be skillful in authoring and executing calibrations, preventative maintenance, repair work where applicable, and other service-related work and documentation.
• Mustdemonstrate 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, ICP-MS, and dissolution.
• Basic understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters.
• Sound knowledge of Pharmaceutical regulation and guidelines including cGMP, ALCOLA+, FDA CFR 211, GAMP, and NIST as applied to equipment and instrument qualification, calibration and Preventative Maintenance.
• Be able to troubleshoot and repair complex systems and instruments
• Must be focused on problem at hand in a systematic manner and troubleshoot complex systems and instruments.
• Should be able to isolate problem, identify root cause/s, and resolve the issue in a systematic manner.
• Working knowledge of OSHA safe work practices.
• Must be comfortable working with Microsoft Office Applications, including Microsoft Word, and Excel
• Demonstrate  strong people and interpersonal skills including being a team player, problem solver, active listener, easy to work with, etc.
• Must demonstrate clear, concise, and effective communication and written skills when describing technical matters or issues.
• Must be detail-oriented being focused on each project and be able to complete tasks efficiently.
• Should be able to clearly and neatly describe technical issues and be able to document work performed accurately in a technical manner.

How To Apply:

Please reference “Metrology Specialist” in subject line and submit resume with cover letter to mmassoudinia@shieldspharma.com

The information collected to review your application will be processed by the human resources services.

We are committed to adhering to our company objectives and requirements outlined for each position.

We welcome and encourage all applicants for their interest. However, only those applicants that are qualified shall be contacted for interview.

No phone calls please.

Thank You

Kindly refrain from applying if you are not  fully qualified (i.e., work status in Canada, Qualification, Years of Experience, Industry knowledge, and related skills).