About Us
Biolyse Pharma is a pharmaceutical company specializing in the development and manufacturing of sterile injectable drug products. We are committed to delivering high-quality medicines that meet global regulatory standards while ensuring patient safety.
Position Overview
We are seeking a detail-oriented and motivated Analytical Chemist to join our Quality Control team. The successful candidate will be responsible for performing analytical testing and method validation in support of sterile injectable drug substances and products, ensuring compliance with Health Canada, USP, EP, and ICH regulatory requirements.
Key Responsibilities
- Conduct routine and non-routine analytical testing of raw materials, intermediates, and finished injectable drug products.
- Develop, validate, and transfer analytical methods to support product development and commercial manufacturing.
- Execute stability studies, impurity profiling, and release testing for sterile injectable products.
- Review and interpret analytical data, prepare technical reports, and document all activities in accordance with GMP and data integrity requirements.
- Support investigations, deviations, CAPAs, and OOS/OOT laboratory events.
- Ensure proper calibration, qualification, and maintenance of analytical instruments.
- Collaborate with cross-functional teams (QC Microbiology, QA, Production, R&D) to support manufacturing and regulatory submissions.
Qualifications
- Bachelor’s degree or higher in Analytical Chemistry, Pharmaceutical Sciences, or related field.
- Minimum 2–5 years of relevant laboratory experience in the pharmaceutical industry (sterile injectables experience preferred).
- Hands-on experience with analytical techniques such as HPLC, GC, UV, and FTIR is required.
- Knowledge of GMP, GLP, ICH, and pharmacopeial guidelines (USP, EP, JP).
- Excellent organizational, troubleshooting, and problem-solving skills.
- Ability to work independently and in a collaborative team environment.
What We Offer
- Opportunity to work in a sterile pharmaceutical facility.
- Training and professional development opportunities.
- A collaborative environment focused on innovation, quality, and compliance.
Job Types: Full-time, Permanent
Pay: $19.00-$22.00 per hour
Expected hours: 40 per week
Work Location: In person
