Associate Director Co-Development Launch

Date: Jan 19, 2023

Location: North York, ON, CA, M9L 2W6

Company: Apotex

 

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

Job Summary

 

The Associate Director- Co-Development, Launch will be the Technical Lead for the execution of a portfolio of projects, to be launched and commercialized at Third Party Sites on behalf of Apotex. The portfolio will include solid, liquid, injectable and inhalation dosage forms for Global Markets. In this role, the incumbent will lead the technical launch and commercialization strategy for these projects and will be expected to develop close working relationships with the internal formulation and process teams as wells as long term relationships with the Third-Party Co-Development Partners.   Additionally, the incumbent will work with Global Project Management, Regulatory Affairs, Business Development, Launch Management,  External Supply Operation, and Quality functional area management to deliver projects and achieve milestones according to plan.

Job Responsibilities

 

  • Provide strategic guidance to Co-Development partners for launch, through review of data and information and monitoring technical progress of the projects in line with the project goals.
  • Pro-active management of several projects ranging in complexity from API sourcing to development to launch including Tech Transfer to/from Third party to appropriate Apotex or CMO sites.
  • An active team member for the on-going evaluation and improvement of the Co-Development Process.
  • Works with Co-Development partners to ensure proper timelines and financial terms are secured and met.
  • Uses appropriate interpersonal skills to influence the decision-making process of Co-Development Partners and cross-functional teams across the business.
  • Ensures Apotex Co-Development Team is working effectively to develop efficient and effective goals, project plans, and schedules.
  • Effectively manages the execution of projects through: risk identification and mitigation, issue resolution; appropriate time and capacity management; and, cost management.
  • Ensures that all project activities are supported by proper documentation per regulatory submission requirements.
  • Performs all other tasks and duties as assigned.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • All other relevant duties as assigned.

 

Job Requirements

 

  • Ph.D degree in chemistry, biology, pharmaceutical or health sciences with a minimum of 7 years progressive experience in the pharmaceutical industry, M.S with a minimum of 10 years of progressive experience in the pharmaceutical industry or B.S. degree with a minimum of 15 years of progressive experience in the pharmaceutical industry
  • Excellent communication, presentation and interpersonal skills.
  • Excellent conflict management skills
  • Demonstrated experience “to win” in a strong matrix, fast paced environment
  • Demonstrated experience in supervising, influencing and coordinating the complex activities and interaction of staff, including non-direct reports.
  • Demonstrated experience developing leadership skills of direct reports.
  • Strong organisational skills; ability to work independently and manage priorities
  • Proven Leadership skills
  • Demonstrated knowledge of the generic product development process
  • Knowledge of Canadian, US and EU regulatory guidelines an asset
  • Knowledge of sterile (injectable and ophthalmic) development and submission a must
  • Experience in complex injectables (nanoparticulates, microspheres, liposomes, etc.) and inhalation products an asset

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process.  If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.