Careers – Shields Pharma Inc.

Career Opportunities

We currently have the following employment opportunities:

Senior Laboratory Analyst – Level III (LC-MS/MS & GC-MS/MS SME)

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 Operation

About 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 hr@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.

QC ANALYST (Level – 2)

ABOUT SHIELDS PHARMA INC.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

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: QC ANALYST (Level – 2) Full-time

REPORTS TO: Director of Laboratory Operation

POSITION SUMMARY:

The main responsibility of this position is to generate accurate results while following GMP requirements. Responsible for analyzing laboratory raw material, in-process, and finished products samples using various chemical and instrumental techniques, in accordance with compendial; USP, BP, EP, and JP methods and specifications and established in-house testing methods, while under minimum supervision.

The Quality Control Analyst is responsible to operating, maintaining, performing and basic troubleshooting of analytical instruments, including; Dissolution, HPLC, UPLC, LC/MS, GC, GC/MS, ICP-MS, etc.

ESSENTIAL FUNCTIONS

Perform raw material, in-process, finished product, and stability sample testing using instrumental analytical, wet chemicals, and physical analytical methods and techniques following the written procedure or compendial methods.
Prepare analytical equipment for experiments; Including reagents, standards, test solutions, and mobile phase as required by the test procedure.
Perform analytical method Transfer, Verification, 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
Ordering general lab supplies (chemicals/non-chemicals) when required.
Document analytical test results in lab notebooks; Ensure the data generated is accurate and meets the specifications, report results on the testing worksheets (finished products and raw materials) according to standard operating procedures in a timely manner, meeting specified deadlines.
Maintain laboratory lab-books, equipment logbooks, and trackers on daily basis in accordance with department policies and procedures.

Demonstrate sound knowledge of Pharmaceutical Compendial (i.e., USP, BP, EP, JP, etc.) General Chapters’ methods
Effectively manage the prioritization to meet multiple goals and timelines.
Demonstrate a strong understanding of cGMP, cGLP, Health Canada, FDA, ICH, and other regulatory guidelines
Be able train new or existing personnel as identified by QC management.
Notify any aberrant/OOS/OOT results to QC management and participate to investigate results following the SOP.
Conduct laboratory instruments qualification, calibration, and preventive maintenance when requested

POSITION 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. or B.Sc. degree in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines with at least of 4 years direct hands-on experience working in pharmaceutical disciplines.
Solid knowledge and expertise (including operation, Qualification, trouble-shooting, and maintenance) working with laboratory instrumentation such as Dissolution, HPLC, GC, ICP-MS, UV-VIS, FT-IR, TOC, TLC, KF, etc.
Familiarity to LC/MS/MS instrumentation and Nitrosamine impurity analysis would be an advantage
Possess extensive experience and in-depth technical knowledge in the method validation, and application of analytical methods used to support pharmaceutical product development and quality control. This includes a strong focus on assay determination, related substances (impurities) analysis, and residual solvents (organic volatile impurities) testing, aligned with ICH, USP, EP, and regulatory expectations.
Well versed in understanding USP, BP, EP, and JP, methods and specifications.
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.
Strong attention to detail
Strong problem solving and analytical skills including decision analysis and implementation
Computer Proficiency with MS office (Excel, Word, PowerPoint), Spreadsheets, etc.
Strong ability to function as a team member; ability to communicate effectively with team members and other plant personnel, both verbally and in writing
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.

HOW TO APPLY

Please reference “QC Analyst (Level – 2)” in subject line and submit resume with cover letter to hr@shieldspharma.com

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.

No phone calls please.

Mycologist

Job Title: Mycologist

Shields Pharma Inc.
Address: 60 Shields Court, Markham, Ontario, L3R 9T5

Job Type: full-time, permanent
Work Location: in person
Language of Work: English
Work Hours: 40 hours per week / 8 hours per day
Wage: $40 per hour
Vacation: 2 weeks
Health Benefits: Health care, dental, and vision

About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

Shields Pharma Inc. is an equal opportunity employer committed to diversity and inclusion for everyone. We are continuously looking for smart-minded, qualified, 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.

Job Description:

The Mycologist is responsible for conducting advanced research on fungal biology, with a primary focus on Psilocybe species. This role supports the development, optimization, and scaling of fungal cultivation methods, contributes to new product development, and ensures compliance with product quality and safety standards. The Mycologist will work collaboratively across research and operations teams to translate scientific findings into practical, commercial applications.

Conduct research into the structure, function, ecology, biotechnology and genetics of fungi, with an emphasis on Psilocybe species.
– Perform research into strain variation, phenotypic expression, and yield optimization across multiple Psilocybe species.
Conduct research on the effects of environmental factors, such as temperature, light, and humidity, on mushroom growth.
Conduct research into the structure and functioning of fungi tissues and mycelium.
– Prepare, maintain and characterize fungal cultures using agar media, slants, liquid cultures, and controlled bioreactors.
– Conduct experiments related to strain identification, selection, and genetic stability to develop improved cultivation or production methods, and maintain a genetic library of fungal strains
Investigate microbial contamination, pathogens, and deviations by performing environmental monitoring, colony-forming units (CFU) tracking, and contamination control assessments, and by developing corrective and preventive strategies.
Participate in feasibility studies related to commercialization of fungal-derived products or processes.
Apply biostatistical and data-driven analytics to cultivation outcomes to refine processes and improve predictability to develop new methods of optimal growth of fungi.
Develop, refine, and validate cultivation methods, workflows, and protocols related to fungal cultivation, environmental control, and product development.
Maintain laboratory quality systems and documentation in accordance with Good Documentation Practices (GDP), internal SOPs, and regulatory expectations, including recording experimental data, procedures, and analysis.
Ensure a sterile and compliant laboratory environment by performing equipment operation, sanitation, calibration, and safety checks aligned with standard laboratory practices.
Work collaboratively with the Operations team to align research outputs with production requirements, and provide technical support, training or supervisory guidance to laboratory technicians.
Conduct research to develop new product formulations derived from fungal biological materials.
Conduct data analysis, modelling, and preparation of internal research reports.

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

Bachelor’s degree in Microbiology, biology, Mycology, Biotechnology or similar applied scientific disciplines.
Minimum 1 year of experience in mycology, microbiology, or mushroom cultivation, preferably in a GMP-regulated environment.
Understanding of aseptic techniques sterile, and sanitation practices.
Working knowledge in microbiological and/or mycology laboratory techniques and instrumentation.
Effective written and verbal communication skills.
Proficiency with MS office (Excel, Word, PowerPoint).

How To Apply:

Please reference “Mycologist” in subject line and submit resume with cover letter to hr@shieldspharma.com.

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.

No phone calls please.

Senior Synthetic Organic Chemist

About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

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 Synthetic Organic Chemist

Reports To: Chief Scientific Officer (CSO)

The ideal candidate will have a diverse organic chemistry skillset with experience in small molecule and carbohydrate synthesis.

Skills and Experiences Required:

Demonstrate sound knowledge of synthetic organic chemistry transformations as well as methodologies such as liquid-liquid extractions, adsorptions, column chromatography, TLC, etc.
Knowledge of synthetic organic chemistry transformations as well as methodologies (i.e., liquid-liquid extractions, adsorptions, column chromatography, TLC, etc.).
Plan & execute R&D projects independently, by running a consistent background, patent and literature search and setting up a timelines and milestone plans.
Independently perform laboratory tests to produce reliable and precise data to support scientific investigations, publications and patents.
Design and execute experimental setups independently and follow strict methodologies to carry out analyses.
Demonstrated hands on laboratory experience preparing a diverse range of synthetic compounds.
Demonstrate skills in planning and execution of R&D experiments.
Ability to analyze and characterize organic chemistry molecules according to different techniques.
Thorough understanding of cGMP, quality, and regulatory requirements for drug substance and drug products manufacturing.
Be able to analyze and characterize organic chemistry molecules according to different techniques including; FT-IR, UV, HPLC, LC/MS, LC/MS/MS, GC, GC/MS, etc.
Familiarity with Health Canada, FDA, and ICH guidelines.
Ensure all documentation including lab reports, records of procedures, results, and data analysis are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
Ability to conduct multiple projects simultaneously and be detail oriented.
Strong computer skills including Microsoft Word, Microsoft Excel, Microsoft Outlook.
Excellent written and verbal communication skills, with the ability to present complex technical data clearly to both technical and non-technical audiences
Attention to detail.
Maintaining a safe and well-organized laboratory work area.

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. with min. 2 yrs. experience, or B.Sc. with min. 3 yrs. industry experience, preferably in Organic Synthesis and Pharmaceutical Analytical Chemistry.
Preference will be given with those with an emphasis in Organic Chemistry. Relevant experience may be considered in place of a higher degree.
Must have a strong knowledge of organic chemistry and hands-on experience in the synthesis of complex organic molecules.
Should be well versed in understanding 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.
Must demonstrate solid technical knowledge and extensive expertise on operation, qualification, trouble-shooting, and maintenance of sophisticated laboratory instrumentation and equipment including, LC/MS, LC/MS/MS, UPLC, HPLC, GC-Headspace, and GC/MS.
Experience with state of the art techniques and characterization of synthetic molecules.
Must be highly motivated and have a proven record of success in multiple projects
Proficiency to MS office (Excel, Word, PowerPoint) is a must
Must demonstrate ability to conduct independent research and have strong communication/teamwork skills in a dynamic environment.
Excellent written and verbal communication skills.
Be punctual, team player, fast learner, and have strong Interpersonal and communication skills.

How To Apply:

Please reference “Senior Synthetic Organic Chemist” in subject line and submit resume with cover letter to hr@shieldspharma.com

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.

No phone calls please.

QC Chemist (Level – 1)

ABOUT SHIELDS PHARMA INC.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

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: QC Chemist (Level – 1) Full-time

REPORTS TO: Director of Laboratory Operation

POSITION SUMMARY:

This is a lab-based position and will assist the QC Supervisor and Technical Department with various QC functions on daily basis for the successful and smooth functioning of the QC unit as a whole.

The Quality Control Chemist is responsible to perform all phases of chemical testing of raw material, in-process, and finished product control samples and performing analytical testing following the written procedure or compendial methods (i.e., USP, EP, BP, etc.) under supervision and instruction; Prepare analytical equipment for experiments, including reagents, standards, test solutions, and mobile phase as required by the test procedure. Receive, organize and distribute samples according to the procedures; document testing results appropriately ensuring the data meets the specifications. Operate, maintain, and perform basic troubleshooting of analytical instruments, including; Dissolution, HPLC, UV-VIS, TOC, KF, IR, Potentiometer, LOD, Titration, etc.

ESSENTIAL FUNCTIONS

Perform raw material, in-process, finished product, and stability sample testing using instrumental analytical, wet chemicals, and physical analytical methods and techniques following the written procedure or compendial methods; Prepare analytical equipment for experiments; Including reagents, standards, test solutions, and mobile phase as required by the test procedure.
Maintain accurate documentation including lab reports, records of procedures, results, and data analysis in accordance with Good Documentation Practices (GDP) guidelines
Ordering general lab supplies (chemicals/non-chemicals) when required.
Document testing results in lab notebooks; Ensure the data generated is accurate and meets the specifications, report results on the testing worksheets (finished products and raw materials) according to standard operating procedures in a timely manner, meeting specified deadlines.
Maintain laboratory lab-books, equipment logbooks, and trackers on daily basis in accordance with department policies and procedures.
Send out raw materials and finished products as per company policy and procedures.
Effectively manage the prioritization to meet multiple goals and timelines.
Conduct laboratory housecleaning and upkeep, maintain and promote a safe and orderly work area.
Participate in laboratory overall improvement, and other work/duties as assigned as well as other miscellaneous duties as required.
Adhere to established company procedures, cGMP, cGLP, Health Canada, FDA, ICH, and other regulatory regulations.
Provide guidance, and training new or existing personnel as identified by QC management.

POSITION 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 B.Sc. in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines with at least of 2 years hands-on experience working in pharmaceutical and/or allied industries.
Solid knowledge and expertise (including operation, Qualification, trouble-shooting, and maintenance) working with laboratory instrumentation such as Dissolution, HPLC, UV-VIS, TOC, KF, IR, Potentiometer, etc.
Well versed in understanding USP, BP, EP, and JP, methods and specifications.
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.
Strong attention to detail
Strong problem solving and analytical skills including decision analysis and implementation
Computer Proficiency with MS office (Excel, Word, PowerPoint), Spreadsheets, etc.
Strong ability to function as a team member; ability to communicate effectively with team members and other plant personnel, both verbally and in writing
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.

HOW TO APPLY

Please reference “QC Chemist (Level – 1)” in subject line and submit resume with cover letter to hr@shieldspharma.com

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.

No phone calls please.

Pharmaceutical Computerized Systems and IT Support Specialist

About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

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 Computerized Systems and IT Support Specialist (Full-time) – 2 Positions

Reports To: V.P. of Operation

Job Summary:

The Computerized Systems and IT Support Specialist supports all departments within Shields Pharma Inc. and is well-versed in current software and technological trends in traditional visual effects workflows, as well as next generation software, hardware and cloud services related to content creation and virtual production following internal procedures and Good Manufacturing Practices (GMP).

The Computerized Systems and IT Support Specialist will provide strategic and operational leadership for all IT systems supporting production, Quality Control laboratory, Pharmaceutical Science and Technology, and Research and Development (R&D) across Shields Pharma Inc. operation. This role is responsible for aligning technology capabilities with business needs, ensuring regulatory compliance, optimizing digital transformation initiatives, and driving innovation across end-to-end to processes.

Roles and Responsibilities (including, but are not limited to) :

Conduct implementation, enhancement and support of Agilent Open Lab CDS with ECM XT Server, Client and Instrument Configuration, Agilent Cary WinUV Server and Client, Agilent MassHunter Software for GC/MS and ICP/MS Systems, PerkinElmer FTIR Spectrum Software, Madgetech 4 secure software, and Microsoft Domain Network Server, Microsoft Dynamics 365 (D365), and other core platforms.
Performing preventive maintenance and troubleshooting of Shields Pharma computerized controlled systems
Maintain high system availability, performance, and data integrity across all supported platforms.
Support lifecycle management and validation of computerized systems in compliance with GxP and 21 CFR Part 11.
Ensure IT systems meet global regulatory requirements, including GxP, GMP, GLP, GDPR, and ALCOA+.
Analyze user requirements and design and develop Shields Pharma Inc. Network System Architecture (NSA) and specifications.
Collaborate with Quality and Compliance teams to ensure readiness for regulatory audits and inspections.
Oversee governance, risk management, cybersecurity and business continuity plans across supported functions.
Collaborate with all departments and functional teams to ensure IT goals and objectives are aligned.
Collaborate with Operations and Quality to develop key performance indicators (KPIs) for balanced scorecard reporting.
Ensure compliance with security requirements, including phishing awareness training, cybersecurity training as required, and onsite physical security (cameras).
Validate all laboratory and production equipment software, including maintenance of the Computerized System Master Validation Plan, risk assessment, compliance with 21CFR Part 11 and GMP standards.
Develop validation protocols where not provided by vendors and execute validation protocols.
Develop and implement policies and procedures throughout the software development life cycle to maximize the efficiency, effectiveness, and overall quality of software products and information systems.
Create SOPs pertaining to IT systems and write and review related technical documents and standard operating procedures.
Perform all work in compliance with GMP, company SOPs, policies and regulatory and safety standards.
Assess physical and technical security risks to data, software, and hardware
Develop policies, procedures, and contingency plans to minimize the effects of security breaches.
Manage all matters related to physical access to the facility and provide specific access to employees as defined by department heads.
Ensure the maintenance of IT infrastructure, Corporate Network performance, software and computer-related hardware.
Conduct computerized system backups and data recovery processes.
Manage SPI Corporate Network, including user administration, network security, etc.
Review and modify standard operating procedures (SOPs)
Develop and review deliverables of the Software Development Life Cycle (SDLC), such as validation plans, requirements, specifications, traceability matrices, test protocols (IQ, OQ and PQ), qualification reports.
Execute, and/or review qualification protocols to ensure compliance and adherence to applicable guidelines.
Perform a risk analysis and define the qualification process
Manage instrument software versions and releases.
Guide internal departments on how to use technology efficiently.
Work closely with department heads and HR to understand and forecast future technology needs, offer solutions, and deliver high levels of IT support.
Identify solutions to recurring IT issues and minimize technical limitations experienced by staff, allowing them to work without disruption.
Provide user data or any other requested data to the VP of Operations, including software/licensing needs.
Manage software licensing in collaboration with QA, QC and Finance.
Monitor and report IT budgets to assess technological performance.

Qualifications and Education Requirements:

Master’s or Bachelor’s degree in computer science or Information Systems (security, infrastructure, software) or related field
Minimum of 5 years of direct experience in the pharmaceutical information technology space.
Minimum of 3 years of direct and hands-on experience working experience in computerized systems qualification, calibration, PM, trouble shooting, in a pharmaceutical laboratory and production environment.
Familiar with a variety of hand tools, electric meters and calibration standards to perform essential day-to-day duties.
Strong knowledge and understanding of computer systems, software development and IT infrastructure.
In-depth understanding of validation principles, risk assessment, and compliance with pharmaceutical regulatory standards such as 21CFR Part 11, ALCOA+, GXP and GMP.
Experience in developing and executing validation protocols for laboratory and production equipment software.
Proficient in developing policies, procedures, and standard operating procedures (SOPs) for IT systems.
Familiarity with software development life cycle (SDLC) and quality assurance processes.
Excellent knowledge of data security principles, risk assessment, and the development of security policies and procedures.
Strong understanding of networking, network security and system architecture.
Experience in managing software qualifications, licensing and software versions.
Proven track record of improving efficiencies and reducing costs related to software and IT systems.
Familiarity with industry-standard software and systems such as Agilent Open Lab CDS, Agilent Cary WinUV, Agilent MassHunter Software for GC/MS and ICP/MS Systems, PerkinElmer FTIR Spectrum Software, Microsoft Domain Network, Microsoft SQL Server, Desktop Virtualization (VMWare), WAN, LAN, VLAN, TCP/IP, CDP, RIP, RIPv2, Access Control List (ACL), Network Address Translation (NAT), Port Address Translation (PAT), ATM, GPON, MPLS, Multicast, VPN, VOIP and IP CCTV System.
Strong analytical and problem-solving skills to identify and resolve recurring IT issues.
Excellent communication and interpersonal skills to collaborate with department heads, HR and senior management.
Familiarity with IT budgeting and financial reporting.
Knowledge of backup systems and data recovery processes.
Continuous learning mindset to stay updated with advancements in technology and industry best practices.
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.
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 “Pharmaceutical Computerized Systems and IT Support Specialist” in subject line and submit resume with cover letter to hr@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).

Senior QC Laboratory Analyst

About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

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.

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).
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 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.
Be punctual, team player, fast learner, and have strong Interpersonal and communication skills,

How To Apply:

Please reference “Senior QC Laboratory Analyst” in subject line and submit resume with cover letter to hr@shieldspharma.com

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.

No phone calls please.

QC Laboratory Technician

About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

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: QC Laboratory Technician, (Full-time)

Reports To: Laboratory Manager

Job Description:

The Laboratory Technician supports the R&D and Quality Control department and carries out physical activities at the laboratory according to the schedule established by following the procedures, and good Manufacturing Practices (GMP).

Responsibilities shall include, but are not limited to, the following:

Efficiently organizing and maintaining equipment clean,
Receiving, processing, and managing incoming samples, reference standards and reagents and chemicals within QC lab.
Restocking of all laboratory inventories including chemicals, reagents, glassware, consumables, etc.
Managing inventory databases for reagents, chemicals, reference standards, HPLC/GC Columns, etc.
Ordering general lab supplies (chemicals/non-chemicals)
Performing daily verification of balances and pH meters, and purified water TOC & Conductivity , etc.
Verifying and recording all laboratory data loggers (e.g. temperature, humidity, water TOC, etc.) on a daily basis.
Preparing laboratory reagent solutions.
Monitor lab Milli-Q water and send out water samples for testing
Performing, drying (LOD), Titration, filtration, etc. testing as required
Replacing the desiccator desiccants routinely.
Washing, cleaning and drying laboratory glassware
Preparing dissolution media when needed
Performing other related duties as assigned from time to time based on company needs.

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 College diploma in a scientific / technical area or bachelor’s degree in biology, Chemistry, or similar fields
Must have a minimum of 2-3 years of experience working in pharmaceutical laboratory environment/s.
Hands on experiences on UV, IR, TLC, wet chemistry, melting point, distillation, and dissolution equipment and instrumentation.
Sound knowledge and competency in cGMP/GMP, GXP, FDA CFR 211, and quality system standards.
Proficiency with MS office (Excel, Word, PowerPoint)
Track record of multi-tasking – ability to organize, manage, and maintain attention to detail in a fast-paced environment, with minimal instruction on routine work and moderate instruction on new assignments.
Punctual, Team player, fast learner, sound verbal and written communication skills,

How To Apply:

Please reference “Laboratory Technician” in subject line and submit resume with cover letter to hr@shieldspharma.com

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an 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).

Pharmaceutical QA Associate and Data Reviewer

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 psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and problematic substance abuse..

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
Continuous training and skill development

We are currently looking for a Pharmaceutical QA Associate and Data Reviewer to join our growing team!

Position Title: Pharmaceutical QA Associate and Data Reviewer (Full-time)

Reports To: Head of Quality & Compliance

Job Description:

The QA Associate and Data Reviewer is a technical expert in our QA department operation, responsible for planning and execution of Quality Assurance deliverables, while overseeing and evaluating the technical aspects of the work performed by the department.

You will use your expertise and skills to ensure the Quality and Compliance department performance and service meets the highest quality, regulatory and industry standards.

As a Senior Quality and Compliance Specialist you should have a sound knowledge of pharmaceutical cGMP, GxPs, GDP, ICH, FDA CFR 211, ALCOLA+, etc. guidelines and regulations.

This position relies heavily on a comprehensive understanding of laboratory operations, analytical methods and instrumentation including general wet chemistry and instrumentation such as LC/MS/MS, HPLC, GC-Headspace, GC/MS, ICP-MS and Dissolution. We are seeking a motivated individual with a pharmaceutical quality assurance background to play a critical role and provide quality oversight on processing of all internal & external GxP documentation. This position reports to the Head of Quality & Compliance department.

Duties shall include, but are not limited, to the following:

Ensuring the company processes, procedures and policies are complying with current Health Canada, US FDA, WHO, and European Good Manufacturing Practices (GMPs), GxPs, ICH, MHRA, ALCOLA+ guidelines and regulations.
Performing Quality Control (QC) and R&D technical, scientific, and compliance review of data and documentation generated by the laboratory including lab reports, records of procedures, results and data analysis.
Identifying deviations, OOS and OOT associated with analytical testing data as applicable.
Issuing QC review observations and working closely with the scientific staff to ensure data integrity.
Collecting metrics data used to monitor the QC reviews, and may identify process improvements
Assist in educating, guiding and influencing the laboratory staff in regard to best practices in GxP compliance.
Developing GMP documentation such as SOPs, forms, protocols, reports, etc.
Demonstrating sound knowledge of the operation of analytical and quality control activities.
Ensuring all data and documentation generated by the laboratory are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
Leading laboratory investigations from initiation to closure of investigation.
Preparing and approving analytical test results CoAs.
Leading, conducting and/or participating in deviations, laboratory OOS and OOT investigations, managing change controls, CAPA and customer complaints
Managing and delivering company’s training program.
Coordinating and participating in Shields Pharma Inc. inspection programs including; internal audits, client and supplier audits and regulatory inspections.
Providing inspection readiness support including front room and backroom activities.
Working with cross functional stakeholders to ensure follow-up of quality issues as requested.
Ensuring equipment/instrument qualifications, calibrations, repairs and maintenance documentations are reviewed, up-to-date, and archived.

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 B.Sc. degree in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines.
Minimum of 3 years of direct and hands-on experience working in pharmaceutical QA .
Sound knowledge of pharmaceutical analytical method development, method validation, investigational studies, method transfer, stability studies and preparation/execution of protocols, etc.
Well versed in understanding of USP, BP, EP, and JP methods and specifications.
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.
Be able to conduct laboratory investigation and other quality attributes (e.g. SOP development, Change Control, Deviation, Root Cause investigation and analysis, CAPA, etc.).
Experienced in creating, and reviewing SOPs, OOS, Change Control, etc. reports
Track record of multi-tasking, being detail-oriented, trouble-shooting/problem solving abilities, working with minimal instruction on routine work and moderate instruction on new assignments.
Strong problem-solving skills, with sound judgment and the ability to make decisions independently while balancing business needs, quality and compliance risks.
Strong organizational skills and the ability to manage multiple tasks and responsibilities in a dynamic work environment
Be able to work in a fast-paced environment with significant responsibilities and follow assignments through to completion to meet agreed timelines.
Be a team player, punctual and have strong communication skills.
Proficiency with MS office (Excel, Word, PowerPoint)

How To Apply:

Please reference “Pharmaceutical QA Associate and Data Reviewer” in subject line and submit resume with cover letter to hr@shieldspharma.com

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

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.

No phone calls please.

Senior Quality and Compliance Specialist

About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

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
Continuous training and skill development

We are currently looking for a Senior Quality & Compliance Specialist to join our growing team!

Position Title: Senior Quality and Compliance Specialist (Full-time)

Reports To: Head of Quality & Compliance department

Job Description:

The Senior Quality and Compliance Specialist is a technical expert in Quality Assurance, responsible for planning and execution of Quality Assurance deliverables, while overseeing and evaluating the technical aspects of the work performed by the department.

You will use your expertise and skills to ensure the Quality and Compliance department performance and service meets the highest quality, regulatory and industry standards.

As a Senior Quality and Compliance Specialist you should have a sound knowledge of pharmaceutical cGMP, GxPs, GDP, ICH, FDA CFR 211, ALCOLA+, etc. guidelines and regulations.

Duties shall include, but are not limited, to the following:

Ensuring the company processes, procedures and policies are complying with current Health Canada, US FDA, WHO, and European Good Manufacturing Practices (GMPs), GxPs, ICH, MHRA, ALCOLA+ guidelines and regulations.
Prioritizing and managing compliance projects.
Supporting the maintenance and improvement to quality systems and processes as needed.
Developing GMP documentation such as SOPs, forms, protocols, reports, etc.
Demonstrating sound knowledge of operation of analytical and quality control activities.
Reviewing all laboratory documentation including lab reports, records of procedures, results and data analysis ensuring that they are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
Reviewing laboratory methods, analytical data, calibration and validation reports/protocols.
Leading laboratory investigations from initiation to closure of investigation.
Preparing and approving analytical test results CoAs.
Leading, conducting and/or participating in deviations, laboratory OOS and OOT investigations, managing change controls, CAPA and customer complaints
Managing and delivering company’s training program.
Lead and coordinate Shields Pharma Inc. inspection programs including; internal audits, client and supplier audits and regulatory inspections.
Management of quality systems, batch document review and product release related to the manufacturing of final products.
Providing inspection readiness support including front room and backroom activities.
Working with cross functional stakeholders to ensure follow-up of quality issues.
Ensure equipment/instrument qualifications, calibrations, repairs and maintenance documentations are up-to-date and archived.

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 Science degree in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines.
Minimum of 4 years of direct and hands-on experience working in pharmaceutical QA environment.
Should demonstrate strong people management, Interpersonal and decision-making skills.
Sound knowledge of pharmaceutical analytical method development, method validation, investigational studies, method transfer, stability studies and preparation/execution of protocols, etc.
Well versed in understanding of USP, BP, EP, and JP methods and specifications.
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.
Be able to conduct laboratory investigation and other quality attributes (e.g. SOP development, Change Control, Deviation, Root Cause investigation and analysis, CAPA, etc.).
Experienced in creating, and reviewing batch records
Track record of multi-tasking, being detail-oriented, trouble-shooting/problem solving abilities, working with minimal instruction on routine work and moderate instruction on new assignments.
Strong problem-solving skills, with sound judgment and the ability to make decisions independently while balancing business needs, quality and compliance risks.
Strong organizational skills and the ability to manage multiple tasks and responsibilities in a dynamic work environment
Be able to work in a fast-paced environment with significant responsibilities and follow assignments through to completion to meet agreed timelines.
Be a team player, punctual and have strong communication skills.
Proficiency with MS office (Excel, Word, PowerPoint)

How To Apply:

Please reference “Senior Quality and Compliance Specialist” in subject line and submit resume with cover letter to hr@shieldspharma.com

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

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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