Scientific leader guiding liquid pharmaceutical manufacturing at Apotex, a Canadian health-products company. Leading technical teams, validation, technology transfer, troubleshooting, and process improvement.
Responsibilities
Provide technical leadership for commercial liquid dosage form manufacturing processes
Lead resolution of complex formulation, process, equipment, and product performance challenges
Serve as technical authority for high-risk manufacturing issues, major deviations, product quality events, and regulatory observations
Provide technical guidance during commercial manufacturing, process validation, technology transfer, and product launch activities
Review and approve technical investigations, scientific assessments, change controls, and process-related recommendations
Lead process optimization, remediation, supplier-driven changes, alternate source qualifications, and product lifecycle management initiatives
Identify opportunities to improve process capability, product robustness, manufacturing efficiency, and operational performance
Apply scientific and statistical methodologies to evaluate process performance, identify risks, and drive sustainable improvements
Evaluate emerging technologies and industry best practices
Partner with Operations, Quality, Validation, Regulatory Affairs, Procurement, Planning, Supply Chain, and R&D
Lead cross-functional teams executing complex technical projects and strategic manufacturing initiatives
Assess and mitigate technical risks involving processes, raw materials, equipment, and product changes
Act as technical representative during regulatory inspections, customer audits, and corporate reviews
Conduct performance conversations and monthly one-on-ones with employees
Develop and coach employees, hire and onboard talent, and ensure compliance with company policies and programs
Requirements
Bachelor's Degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering, or a related scientific discipline
Advanced knowledge of pharmaceutical liquid dosage form manufacturing processes, formulation science, process validation, technology transfer, and lifecycle management
Strong understanding of cGMP requirements, regulatory expectations, quality systems, risk management, and change control processes
Demonstrated expertise in troubleshooting complex manufacturing, formulation, process, and equipment-related issues
Strong analytical, root cause analysis, risk assessment, and decision-making skills
Ability to lead complex technical initiatives and influence cross-functional stakeholders across multiple functions and sites
Strong project management, prioritization, and organizational skills
Excellent verbal, written, and presentation communication skills
Proven ability to develop, coach, and lead technical professionals while fostering a high-performance culture
Strong stakeholder management skills
Proficiency in Microsoft Office applications and data analysis tools
Ability to exercise sound judgment and make effective decisions in a fast-paced, highly regulated manufacturing environment
Minimum 10-12 years of progressive pharmaceutical industry experience supporting liquid dosage form development, manufacturing, technical services, process support, validation, and technology transfer
Demonstrated experience leading complex technical investigations, manufacturing improvement initiatives, and cross-functional projects
Minimum 3-5 years of leadership experience managing technical professionals, scientists, engineers, or project teams
Experience with regulatory inspections, customer audits, and implementation of corrective and preventive actions
Proven ability to lead strategic initiatives and influence technical and business decisions with significant quality, compliance, operational, or supply impact
Benefits
Bonus programs based on position in the organization
Comprehensive benefits
Pension plan
Learning and development opportunities
Accommodation for applicants with disabilities during recruitment
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