Sr. Scientific Leader , Liquid Manufacturing

Manufacturing Technical Services - Technical Support Services (MTS-TSS) is responsible for supporting the commercial manufacture of pharmaceutical liquid dosage forms through technical troubleshooting remediation technology transfer process optimization validation support continuous improvement initiatives and lifecycle management activities.

The Manager Liquid Manufacturing Technical Support Services provides scientific and operational leadership for commercial liquid manufacturing processes across Apotex manufacturing sites. The role is accountable for leading a team of technical professionals responsible for resolving complex manufacturing formulation equipment and process-related challenges while ensuring products are manufactured safely compliantly and efficiently.

Working closely with Operations Quality Validation Regulatory Affairs Procurement Planning Supply Chain and R&D the incumbent leads high-impact technical initiatives supports critical business and regulatory objectives and drives continuous improvement of manufacturing processes. The role provides both strategic technical direction and people leadership to ensure the successful execution of technical support activities technology transfers process improvements validation programs and product lifecycle management initiatives.

• Provide technical leadership for commercial liquid dosage form manufacturing processes.
• Lead the resolution of complex formulation process equipment and product performance challenges to support quality compliance and supply continuity.
• Serve as the technical authority for high-risk manufacturing issues major deviations product quality events and regulatory observations.
• Provide expert 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 technical initiatives supporting process optimization remediation activities supplier-driven changes alternate source qualifications and product lifecycle management.
• 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 and recommend opportunities for implementation.
• Partner with Operations Quality Validation Regulatory Affairs Procurement Planning Supply Chain and R&D to support business objectives and manufacturing success.
• Lead cross-functional teams in the execution of complex technical projects and strategic manufacturing initiatives.
• Assess and mitigate technical risks associated with manufacturing processes raw materials equipment and product changes.
• Act as a technical representative during regulatory inspections customer audits and corporate reviews.
• Participate and lead performance conversations with employees including monthly one on ones to connect on performance; check in on employees progress toward achieving Objectives offer support and remove barriers; and communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open honest two way communication to build trust-based relationships with employees business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values Integrity Teamwork Courage and Innovation.
• Utilize your networks to attract and hire talent in a comprehensive differentiated and consistent manner essential to our continued growth; then onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned.

• Education
  • Bachelors Degree in Chemistry Pharmacy Pharmaceutical Technology Chemical Engineering or a related scientific discipline.
  • Advanced degree (. Ph.D. or equivalent) is considered an asset.

• Knowledge Skills and Abilities
  • 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 with the ability to build effective working relationships across Operations Quality Regulatory Affairs Validation Supply Chain Procurement and R&D.
  • 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.
    
    
• Experience
  • 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 supporting commercial pharmaceutical manufacturing operations and product lifecycle management activities.
  • 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.