PSYGEN LABS INC.
Process Chemist – Production Lab Lead
Overview
Psygen is seeking a highly skilled and motivated Process Chemist – Production Lab Lead to join our dynamic team. The successful candidate will be responsible for the execution, scale-up, and continuous improvement of GMP manufacturing processes for Active Pharmaceutical Ingredients (APIs).
The selected candidate will be involved in all stages of process implementation from technology transfer and scale-up through to commercial manufacturing, ensuring the safe, efficient, and consistent production of high-quality drug substances. This individual will play a pivotal role in leading production laboratory operations, supporting manufacturing campaigns, and driving ongoing process improvements.
The Process Chemist – Production Lab Lead will report directly to the Chief Science Officer and work within the Psygen Operations Team to ensure that objectives and milestones are achieved for manufacturing and process-related projects.
Key Responsibilities
· Execute and oversee GMP manufacturing campaigns for APIs
· Lead transfer of processes from development into production
· Evaluate and implement scale-up procedures
· Supervise production chemists and technicians
· Ensure readiness of materials, equipment, and documentation
· Set up and qualify large-scale manufacturing equipment (IOQ/PQ)
· Draft, review, and execute batch records (MBRs/PBRs)
· Troubleshoot process deviations and manufacturing issues
· Lead investigations, root cause analysis, and CAPAs
· Collaborate with QA and QC for batch release readiness
· Monitor and improve yield, cycle time, and efficiency
· Identify and mitigate scale-dependent risks
· Support process validation and continued verification
· Apply Quality by Design (QbD) principles
· Maintain GMP and GLP compliant records
· Draft SOPs, batch records, and reports
· Ensure adherence to safety and regulatory requirements
· Collaborate with QA, QC, and Materials Management
The ideal candidate must demonstrate:
· Strong proficiency in synthetic organic chemistry, from gram- to kilo-scale
· Ability to execute and troubleshoot multi-step processes at scale
· Experience in scale-up and technology transfer
· Strong understanding of process chemistry and process controls
· Proficiency with jacketed reactors setup and use is a required asset
· Ability to lead production activities and supervise staff
· Experience with deviation investigations and CAPAs
· Strong knowledge of GMP, GLP, and regulatory expectations
· Proficiency with HPLC, LCMS, and NMR
· Experience with production equipment and lab systems (ELN, LIMS, ERP)
· Strong organization, attention to detail, and adaptability
The Ideal Applicant Will Have:
· MSc or PhD in Organic Chemistry
· 5+ years of experience in pharmaceutical process chemistry with GMP exposure
· Experience transferring processes into kilo-scale manufacturing
· Experience supervising laboratory staff
· Strong problem-solving and critical thinking skills
· Excellent communication and teamwork abilities
· Experience in a startup or scale-up environment
· Knowledge of cGMP, ICH, and FDA regulations
· Eligibility for A/QPIC status in Canada
Job Type: Full-time
Pay: $90,000.00-$110,000.00 per year
Benefits:
- Casual dress
- Dental care
- Extended health care
- Life insurance
- Paid time off
- Stock options
- Vision care
- Wellness program
Flexible language requirement:
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
