St. Catharines, On Directeur principal, cmc/sr. director, cmc Jobs – 1 Openings This Week

R&D Chemist
Biolyse Pharma Corp —St. Catharines, ON
- $20–$22 an hour
- Full-time
- Laboratory experience
- Master's degree
- Bachelor's
Quick apply

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R&D Chemist

Biolyse Pharma Corp -
St. Catharines, ON

Quick apply

Job details

Permanent | Full-time
$20–$22 an hour

Qualifications

Biochemistry
Laboratory experience
Master's degree
Bachelor's
APIs
Chemistry

Full job description

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

Quick apply

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R&D Chemist

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