Job Summary

This position is responsible for new product launch activities for assigned projects or product categories by leading the Product Development North America - New Product Launch (PDN - NPL) team and serving as a technical resource to support the launch of Apotex’s new product pipeline.

The incumbent will lead process development, scale-up and process validation activities for immediate release and modified release solid oral dosage forms manufactured by various manufacturing processes including dry granulation, wet granulation, hot melt extrusion, pelletization, etc.

This role will guide the team to perform technical risk assessment and design process optimization trials using DOE, where applicable, to understand and correlate the interactions between scale dependent CPP and CQAs to ensure a Right FirstTime approach into process validation.

Job Responsibilities

• Provide strategic direction and technical leadership in the development and management of product scale-up activities, optimization processes and validation strategies.
• Lead the PDNA NPL Team in development and deployment of quality management systems to detect, investigate, and resolve all issues to ensure projects are planned and executed in timely manner
• Partners with stakeholders across multiple functions and levels, to effectively communicate and manage project scope, resource allocation, key deliverables, costs, risks and emerging issues.
• Provides strategic oversight of multiple concurrent initiatives and workstreams to support timely development, Regulatory approval, and commercialization of Apotex’s product pipeline for local and international markets.
• Accountability for ongoing evaluation of PDNA New Product Launch processes, procedures and technology with recommendations for change, to ensure alignment with Apotex strategic objectives, while ensuring compliance with Regulatory requirements.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s 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 – Collaboration, Courage, Perseverance and Passion.
• 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.

Job Requirements

• Education
  • University degree in Pharmacy, Pharmaceutics, Industrial Pharmacy, Pharmaceutical Technology, Chemical Engineering
• Knowledge, Skills and Abilities
  • Sound knowledge of QBD, ICH, FDA, TPD and other regulatory guidance documents; in depth understanding of all pertinent SOPs, GMP, GLP and GDP.
  • Working knowldge of various manufacturing processes, including dry granulation, wet granulation, hot melt extrusion, pelletization, etc.
  • Excellent written and verbal English communication skills.
  • Computer literacy: word processing, chemistry drawing, literature search and data generation software.
  • Excellent organizational skills and report writing skills.
• Experience
  • Minimum of 12 years working experience in the pharmaceutical industry.
  • Minimum of 10 years’ experience leading teams with accountability for process development, scale-up and process validation of immediate release and modified release solid oral dosage forms.

• • Extensive experience with various manufacturing processes including, dry granulation, wet granulation, hot melt extrusion, pelletization, etc.
  • Previous experience engaging, influencing and interacting with team members at all levels of the organization.