Formulation Scientist
6 days ago
Key Responsibilities
- Develop a range of oral dosage forms, including tablets, capsules, and liquid formulations.
- Perform foundational research on APIs, excipients, reference products, and relevant patent landscapes.
- Use Quality-by-Design principles to optimize formulation strategies and enhance process robustness.
- Lead activities related to scale-up, feasibility studies, proof-of-concept batches, and registration manufacturing; prepare clear, comprehensive technical and regulatory documentation.
- Collaborate with analytical teams, warehouse operations, regulatory affairs, and tech-transfer personnel to keep projects aligned and on schedule.
- Ensure strict adherence to GMP standards, internal procedures, and safety protocols; act as a technical expert during audits and inspections.
- Review and authorize batch manufacturing records; contribute to internal audit programs and continuous-improvement initiatives such as Lean Six Sigma.
- Maintain organized development records, manage raw-material requests, and oversee technical documentation.
- Offer scientific oversight to CRO partners and support evaluations of new equipment, process enhancements, and emerging technologies.
Skills & Competencies
- Proven experience working with either solid oral dosage development or liquid product formulation.
- Strong understanding of GMP, QbD frameworks, regulatory submission requirements across Canada/US/EU, and proficiency in literature and patent searches.
- Experience with tech transfer, scientific documentation, and preparation for audits.
- Solid grasp of manufacturing equipment, production processes, and established pharmaceutical industry standards.
Qualifications
- Bachelor's degree in Science, Pharmacy, or an equivalent discipline (or comparable technical diploma), accompanied by at least 3–5 years of relevant pharmaceutical industry experience.
Job Type: Full-time
Work Location: In person
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