Process Development Chemist

PSYGEN LABS INC.

Designation: Process Development Chemist

Psygen is seeking a highly skilled and motivated Process Development Chemist to join our dynamic team. The Process Development Chemist will be responsible for developing chemical processes for the manufacturing of GMP psychedelic APIs. The selected candidate will be involved in all the stages of process development, from route scouting/optimization to commercial manufacturing, ensuring the safe and efficient production of high-quality drug substances. The successful candidate will play a pivotal role in the research and development of new drugs, as well as the continuous improvement of existing manufacturing processes.

The Process Development Chemist will report directly to the Director of Laboratory Operations and work within the Psygen Operations Team to ensure that objectives and milestones are completed for any process development and manufacturing projects.

Key responsibilities:

• Develop and optimize multi-step synthetic processes for the production of GMP-grade psychedelic APIs, ensuring compliance with regulatory standards.
• Evaluate and implement scale-up procedures to transfer laboratory-scale processes to larger production equipment and facilities (kilo scale), ensuring process consistency and efficiency.
• Design and execute experiments to identify critical process parameters and establish control limits via prior knowledge, risk assessments, scientific experimentation, mechanistic models, and multivariate statistical analysis (Design of Experiments).
• Participate in all the stages of process validation and contribute to large-scale manufacturing operations performed under GMP.
• Understand the concepts and principles of Quality by Design to integrate quality into the process development and manufacturing phases of a product.
• Collaborate with QC and QA teams to determine critical material attributes of raw materials and critical quality attributes of APIs and maintain quality standards throughout the manufacturing process.
• Analyze and interpret experimental data and make data-driven decisions to improve process efficiency, yield, and safety.
• Ensure that all processes adhere to safety guidelines, environmental regulations, industry standards, and GMP.
• Maintain detailed records of experiments, results, and observations in compliance with Good

Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

• Work closely with cross-functional teams, including QC, QA, Procurement, and Sales, to achieve project goals and timelines.
• Provide regular updates to the direct supervisor, advise on future research directions, and assist in developing project strategy for manufacturing of drug substances to support clinical studies and commercialization.
• Stay updated on industry trends, technological advancements, and emerging methodologies in pharmaceutical process chemistry to implement innovative solutions.
• Ensure workplace safety within the laboratory environment and compliance with all published SOPs and protocols.
• Draft clear and concise process development reports, standard operating procedures, risk assessments, master batch records, and all required documents for internal records and auditing purposes.
• Perform routine maintenance of laboratory equipment as per schedule.

Qualifications and Experience:

• Proficiency with laboratory techniques and ability to work confidently and independently in a synthetic lab.
• Knowledge of the principles and practises of synthetic organic chemistry (e.g., reaction mechanism, retrosynthetic analysis, synthetic route planning, etc.) and ability to develop and execute complex multi-step syntheses.
• Experience in scaling up synthetic routes, focusing on developing safe, cost-effective, and environmentally friendly processes.
• Familiarity with purification techniques at scale, such as automated flash column chromatography, recrystallization, distillation.
• Proficiency in analytical techniques and analytical data interpretation, such as HPLC, LCMS, NMR.
• Experience in the operation, maintenance, and calibration of production lab equipment.
• Confidence using laboratory software including ELN, LIMS, ERP.
• Interest and/or experience in novel technologies for the improvement of process efficiency (e.g., flow chemistry, electrosynthesis, process automation).
• Proven experience with drafting and reviewing project proposals and writing scientific reports.
• Capability to work well in a team on collaborative projects.
• Ability to supervise, instruct, train, and mentor assistants and chemists in the use of lab equipment and implementation of laboratory processes.
• Strict adherence to the regulations as set out by OCS and Health Canada, as per the QA’s interpretations.
• Adaptability according to evolving priorities.
• Minimum level of education: MSc/PhD in Organic Chemistry, or related field.
• Proven experience in pharmaceutical process chemistry (minimum 5 years), with a strong background in chemical synthesis and process development.
• Experience working in a fast-paced environment associated with a startup company.
• Critical thinking and problem-solving skills.
• Excellent communication and teamwork abilities.
• Strong organizational and planning skills.
• Creativity and curiosity, with an investigative and analytical mind.
• Attention to detail and a commitment to maintaining high-quality standards.
• Knowledge of regulatory regimes, including cGMP, FDA, and ICH.
• Eligible for A/QPIC status to work with controlled substances.

Job Type: Full-time

Pay: $75,000.00-$90,000.00 per year

Benefits:

• Casual dress
• Dental care
• Extended health care
• Life insurance
• Paid time off
• Stock options
• Vision care
• Wellness program

Flexible Language Requirement:

• French not required

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Calgary, AB T2A 7X1: reliably commute or plan to relocate before starting work (required)

Application question(s):

• How many years of work experience do you have with cGMP manufacturing?
• How many years of work experience do you have with Pharmaceutical Process Development & Scale-Up for Active Pharmaceutical Ingredients?

Education:

• Master's Degree (required)

Work Location: In person