Senior Manager, R&D Analytical Product Life Cycle Management

Job Summary

Responsible for providing strategic direction to the staff and activities of AD-PLCM/MLCM laboratories at Signet and Etobicoke. Organizes and coordinates product development process in the team-based environment, provides guidance to scientists/chemists, implements team-oriented approach from the earlier stages to completion of the project. Evaluates technical data and decides on course of action during PLCM/MLCM process. Responsible for the quality of newly developed analytical methods as well as their validation to support the regulatory submissions of new API sources, and revision and validation of legacy methods to meet current global regulatory standards.

Job Responsibilities

• Demonstrates corporate values in the performance of the work and interactions with others.

• Works closely with other units of AR&D QC, provides expert advice to other members of the team.
• Liaises across the organization at all levels to provide an in-depth level of expertise.
• Investigates, encourages and uses unconventional/unique problem solving techniques to perform trouble-shooting on highly complex issues with respect to the stability of drug substances and drug products, chromatographic methodology etc.
• Oversees the resolution of more complex issues related to projects.
• Oversees the resolution of all departmental issues with internal customers.
• Contributes to the development of departmental contingency and emergency response plans.
• Performs all work in accordance with all established regulatory, compliance and safety 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
  • Advanced degree, preferably Ph.D. in a scientific discipline especially Organic Chemistry, Analytical Chemistry or Pharmaceutical Sciences
• Knowledge, Skills and Abilities
  • Advanced knowledge and understanding of the principles of solid-state chemistry, pharmaceutical solid dosage forms, in-vivo permeability, and biopharmaceutical issues.
  • Demonstrated technical proficiency, scientific creativity, teamwork, and independent thought process.
  • Excellent written and verbal communication skills.
  • Leadership and supervisory skills demonstrated in previous supervisory/management roles.
  • Good understanding of pharmaceutical regulatory requirements regarding R&D international regulatory expertise is an asset.
• Experience
  • Not less than 5 years, preferably more, of pharmaceutical industry experience with demonstrated achievements in pharmaceutical R&D with focus on analytical research.