Biolyse Pharma Corporation is seeking a motivated and detail-oriented R&D Chemist to join our growing pharmaceutical development team. The successful candidate will play a key role in the development of new pharmaceutical products from early formulation stages through analytical evaluation, validation, regulatory submission support, and commercial readiness.
Key Responsibilities
- Participate in the research and development of new pharmaceutical formulations and manufacturing processes.
- Conduct laboratory-scale formulation trials and process optimization studies.
- Evaluate raw materials, excipients, active pharmaceutical ingredients (APIs), and packaging components for suitability and compatibility.
- Support scale-up activities from laboratory development to commercial manufacturing.
- Work closely with the Regulatory Affairs department to prepare technical documentation required for submissions to government regulatory agencies, including Health Canada and international authorities.
- Assist in the preparation and review of:
- Product development reports
- Stability summaries
- Validation protocols and reports
- Analytical method documentation
- Specifications and test methods
- Chemistry and Manufacturing (CMC) documentation
- Support responses to regulatory questions and technical requests during product review processes.
- Perform analytical testing using techniques such as:
- HPLC / UPLC
- GC
- UV-Vis Spectroscopy
- FTIR
- Dissolution and assay testing
- pH, osmolality, conductivity, and related laboratory analyses
- Develop, optimize, troubleshoot, and validate analytical methods in accordance with ICH, USP, and regulatory guidelines.
- Review analytical data for accuracy, integrity, and compliance with GMP requirements.
- Maintain complete and accurate laboratory records in accordance with ALCOA+ data integrity principles.
- Design and execute validation studies, including:
- Analytical method validation
- Cleaning validation support
- Hold-time studies
- Stability studies
- Process validation support
- Analyze trends and interpret validation and stability data to support product shelf life and manufacturing controls.
- Prepare comprehensive validation reports and technical summaries.
- Source and evaluate suppliers for APIs, excipients, laboratory materials, filters, packaging components, and specialized equipment.
- Communicate with vendors to obtain technical documentation, certificates, specifications, and sample materials.
- Assess material compatibility, quality standards, and regulatory compliance of proposed suppliers.
- Support qualification activities for new materials and suppliers.
Qualifications
- Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or related scientific discipline.
- Experience in pharmaceutical, biotechnology, or regulated laboratory environments preferred.
- Strong understanding of GMP requirements, analytical techniques, and validation principles.
- Experience with sterile injectable products is considered a strong asset.
- Knowledge of ICH, USP, Health Canada, FDA, or EU regulatory requirements is an asset.
- Strong technical writing and documentation skills.
- Excellent problem-solving, organizational, and communication abilities.
- Ability to work independently and collaboratively in a fast-paced environment.
Pay: $20.00-$22.00 per hour
Work Location: In person
