Job Description

Role Overview & Core Duties

Design, develop, and refine oral drug products such as tablets, hard capsules, and liquid dosage forms from early concept through commercialization.
Conduct scientific evaluations of active ingredients, excipients, comparator products, and intellectual property considerations to inform formulation strategy.
Apply Quality by Design (QbD) methodologies to improve formulation performance, process reliability, and lifecycle robustness.
Drive scale-up activities, feasibility assessments, pilot and exhibit batch manufacturing, and registration-stage production, ensuring high-quality technical documentation is prepared and maintained.
Work cross-functionally with analytical development, supply chain, regulatory affairs, warehousing, and technology transfer teams to ensure project timelines and objectives are met.
Ensure compliance with GMP requirements, internal SOPs, and EHS standards; provide technical leadership during regulatory inspections and quality audits.
Approve and review batch records, support internal audit initiatives, and contribute to continuous improvement programs, including Lean or Six Sigma-based projects.
Maintain accurate development files, coordinate raw-material procurement requests, and manage formulation and process documentation.
Provide technical guidance to external partners and CROs, and support assessments of new equipment, process optimizations, and innovative technologies.

Technical Skills & Expertise

Hands-on experience in either solid oral dosage form development or pharmaceutical liquid formulations.
Strong working knowledge of GMP expectations, QbD concepts, and regulatory submission practices across Canadian, U.S., and European markets.
Demonstrated experience in technology transfer, scientific report writing, and audit readiness.
Practical understanding of pharmaceutical manufacturing operations, equipment, and industry best practices.

Education & Experience Requirements

Bachelor's degree in a scientific discipline such as Chemistry, Pharmaceutical Sciences, or Pharmacy (or an equivalent technical qualification), with 3-5 years of relevant experience within the pharmaceutical manufacturing or product development environment.

Job Type: Full-time

Work Location: In person