Senior QC Analyst

Psygen Labs Inc.

jobsincanada.one

December 12, 2022

PSYGEN LABS INC. (PLI) aspires to be a global leader in synthetic manufacture of psychedelic medicines. Our mission is to provide sustainable and equitable access to psychedelic APIs and drug products for clinical research and therapeutic applications.

Psychedelic drugs are experiencing a renaissance in the clinical treatment of a variety of conditions that have eluded widespread successful treatment. Psygen is actively developing technologies and commercial infrastructure for the manufacturing and distribution of psychedelic drugs. This is a unique opportunity to be part of a historical transformation in the mental health and addictions treatment sectors.

Psygen provides a progressive work environment, a competitive compensation and benefits package, and opportunities for personal growth.

QC Analytical Chemist – Summary

Reporting to the Director of Quality Assurance, the successful candidate will be responsible for providing QC support for the R&D and Production teams in a dedicated state-of-the-art 6000 sq ft facility. They will be responsible for the operation of the Quality Control lab, including equipment installation, maintenance, and qualification, analytical method development and validation, analysis of samples, and production of detailed analytical reports. The candidate will collaborate with the Quality Assurance Department to establish specifications for new products and prepare reports for contract development projects.

The QC Analytical Chemist is expected to have an excellent understanding of the applicable Quality and Regulatory GMP requirements to ensure that high-purity cGMP psychedelic APIs are produced to the highest quality standards.

Candidates with extensive hands-on experience with UPLC/HPLC-MS, method development and validation, and knowledge of Waters Empower software, are preferred.

Candidate must be willing to re-locate to Calgary, Alberta.

Responsibilities

  • Report directly to the Director of Quality Assurance, working closely to manage the QC department, and provide QC support to the R&D and Production departments.
  • Perform Installation Qualification/Operational Qualification and maintenance for all analytical laboratory instruments. Ensure calibration is performed as needed.
  • Perform analytical method development and validation. Prepare and execute analytical method validation protocols for all applicable product lines. Assist with the preparation of drug master files and Client CTA/IND filings.
  • Perform materials release (raw materials, intermediates, final products), process validation controls, and sample analysis (UPLC-MS, UV-Vis, melting point, FT-IR).
  • Examine and establish specifications for new drug substances and drug products, as well as for in-process intermediates.
  • Participate in the Water Sampling and Testing and Environmental Monitoring Program for the facility.
  • Plan, schedule, and prioritize laboratory activities to comply with timelines and meet deadlines.
  • · Maintain lab cleanliness and safety, follow cGMP guidelines, and compile records for certification and audit purposes.
  • Develop clear and concise SOPs, handle and organize GMP data, and contribute to project proposals, scientific reports, risk assessments, and other technical documents.
  • Consult with teammates on scientific subjects and active projects, provide feedback and recommendations about interdepartmental matters, and supervise junior team members as needed.
  • Coordinate with Quality Assurance, Production, and Marketing/Sales for batch releases, Out of Specification Investigations, Out of Trend Investigations, Stability Data, Impurity profiles of APIs/ Intermediates, and Market Complaint Reports.
  • Coordinate with the Materials Management department to ensure sufficient inventory of chemicals and supplies to perform planned lab activities.

Qualifications and Experience

  • BSc or MSc in analytical chemistry.
  • Demonstrated experience as analytical/QC chemist in the pharmaceutical industry (5+ years).
  • Extensive hands-on experience with analytical method development and validation, especially for UPLC/HPLC-MS analysis.
  • Proficiency in servicing and maintaining analytical instrumentation, including UPLC, MS, UV-Vis, melting point, FT-IR, and HPLC.
  • Ability to produce high-quality analytical data reports and experience in analytical data interpretation.
  • Extensive experience evaluating analytical methods for their relevance to the control strategy for drug substances.
  • Up to date with current trends in analytical chemistry for the pharmaceutical industry, as well as Health Canada regulations and GMP guidelines.
  • Experience with mentoring junior team members and confidence in laboratory management.
  • Demonstrated ability to design, plan, implement, and execute strategies.
  • Hands-on, resourceful, proactive, and highly detail oriented.
  • Team player who excels in a dynamic environment with challenging timelines.
  • Excellent verbal and written communicator with strong organizational and time management skills.
  • Curiosity driven with the motivation and ability to troubleshoot challenging processes and solve complex technical problems.
  • Committed to continuously improving and updating technical and scientific skills and knowledge.
  • Ability to work independently with minimal oversight.
  • Ability to multi-task and adapt to changing priorities in a team-oriented entrepreneurial environment.

At Psygen, we ensure the highest standards of integrity and principles of quality, diversity, equity, and ethical practice.

We kindly thank all those who submit their resumes. Only those selected for further consideration will be contacted.

Job Type: Full-time

Salary: $65,000.00-$90,000.00 per year

Benefits:

  • Casual dress
  • Company events
  • Extended health care
  • Life insurance
  • Paid time off
  • Stock options

Flexible Language Requirement:

  • French not required

Schedule:

  • 8 hour shift

Ability to commute/relocate:

  • Calgary, AB: reliably commute or plan to relocate before starting work (required)

Application question(s):

  • Do you have experience with UHPLC-MS, GC-MS, UV, IR, DSC, and NMR analysis and interpretation of analytical results?
  • Do you have experience working in a GMP environment?
  • Do you have experience with analytical method development and validation?

Education:

  • Bachelor’s Degree (required)

Work Location: One location

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