Director, CMC
A
AllucentBiopharmaceutical
CanadaFull-TimeDirector
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- >10 years’ post-degree
- Required Skills
- SharePointMicrosoft ExcelPowerPoint
Requirements
- B.S., R.Ph., M.S., Ph.D., or equivalent degree in a scientific area
- Equivalent combination of relevant experience in drug, biologic, or device development
- Advanced scientific and regulatory knowledge of drug, biologic, or device development
- Experience in pre-approval products; large biologics experience required
- Line management experience required
- Prior CRO experience preferred
- Critical thinking and analytical skills
- Financial acumen
- Influencing and leading teams
- Risk assessment
- Strong written and verbal communication skills in English
- Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
- Quality focus
- Strong emotional intelligence, customer focused leadership and decision-making skills
- Innovative, creative, and practical thinking including problem-solving skills
- >10 years’ post-degree of directly relevant experience in drug, biologic, or device development
Responsibilities
- Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects.
- Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
- Prepare product development plans from early development through Phase 4.
- Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.
- Perform other scientist related duties, as needed.
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