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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in manufacturing leadership within a cGMP biopharmaceutical environment, ensuring compliance with regulatory standards and effective training of personnel. Proficient in quality management systems, equipment maintenance, and operational troubleshooting.
Highest-signal resume keywords
Manufacturing LeadershipCGMP ComplianceAseptic Processing KnowledgeQuality Management SystemsBilingualism in French and English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Manufacturing LeadershipCGMP KnowledgeAseptic ProcessingTroubleshootingEquipment MaintenanceProcess ControlBatch Record ReviewSOP AdherenceAutomated Control SystemsStatistical Analysis
Soft Skills
Communication SkillsOrganizational SkillsDocumentation SkillsProblem-Solving SkillsTeam Development
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Project
Industry Keywords
CGMPFDA RegulationsOSHA StandardsEPA RegulationsBiopharmaceutical ManufacturingAseptic OperationsGood Documentation PracticesQuality ControlValidationProcess Scale-Up
Tech Stack
Tools & technologiesReact
About the role
Key responsibilities & impact- Lead and direct daily manufacturing shift activities in the Filling area
- Assign tasks and follow up on progress throughout the shift
- Ensure quality and preventive-maintenance notifications are issued and investigated promptly
- Ensure manufacturing schedules, products, and materials are delivered
- Train, develop, and monitor Filling personnel on process, safety, cGMP, regulatory, and GXP requirements
- Identify development gaps and implement plans and targets
- Review safety cases and implement corrective actions
- Ensure compliance with site procedures, health and safety protocols, and federal health authority regulations
- Adhere to Good Documentation Practices
- Coordinate and draft reviews of batch records and SOPs
- Execute quality management system assignments, including CAPA and change control, to close on time
- Ensure equipment operates properly and coordinate repairs, modifications, emergency work, and preventive maintenance
- Resolve operational and equipment issues and make recommendations
- Coordinate manufacturing activities with Quality Control, Materials Management, Quality Assurance, Validation, and other departments
Requirements
What you’ll need- CEGEP or technical degree mandatory
- Bachelor's degree in Science, Engineering, or related field preferred
- 1 to 3 years of manufacturing leadership/supervisor experience in a cGMP biopharmaceutical environment
- Previous experience in biologics protein filling manufacturing is an asset
- Good understanding of operating principles of process equipment
- Strong knowledge of technical and scientific principles associated with aseptic processing
- Knowledge of automated control systems
- Knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations
- Knowledge of aseptic operations, statistics, equipment design, process control, process scale-up, aseptic pharmaceutical processes, and equipment validation
- Ability to troubleshoot and maintain manufacturing systems, equipment, and processes
- Ability to dress aseptically for cleanroom operations
- Ability to react quickly to understand and solve problems
- Excellent communication, documentation, organizational, and troubleshooting skills
- Ability to accurately read, understand, and follow company SOPs and guidelines
- Proficiency in Microsoft Word, Excel, PowerPoint, and Project
- Bilingualism in spoken and written French and English