Job Description

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

In this role, the incumbent\xe2\x80\x99s responsibility is to manage the API life cycle projects with impacts beyond individual sites or products, in alignment with commercial strategies, GRD project targets and the product portfolio within APG and third party API suppliers. Initiatives include those that support leveraging cost evaluation for internally developed API and provide strategic view on cost competitiveness for the developing process within APG and recommend transition to external API suppliers when necessary.

Job Responsibilities

• Ensure that project milestone tracker is initiated, maintained and adhered to, for successful and timely execution of drug substance projects that have been assigned for internal (APG sites) development.

• For internally developed APIs, during the NPD phase of the product lifecycle, PL will monitor and report progress of project periodically.

• Working in conjunction with GAPI Supply Chain Management, the PL will track and ensure that internal or external suppliers of API are supporting product launch plans.

• For internally developed APIs, PL will monitor and report periodically on the forecasted unit price with a view to having internal processes that are cost competitive with the market pricing for those APIs.

• This role will also provide material quality attribute impact assessment to support the management of Supplier Driven Changes to raw materials (APIs and excipients) throughout the GMP lifecycle of raw materials at Apotex and new source qualifications program.

• Facilitate and drive API OOS/OOT investigations as required. Work closely with Apotex stakeholders to identify root causes and suggest CAPA plans.
• Facilitate with cross functional teams and ensure that prioritization of proposed PLCM projects is understood by all involved and that projects are completed in a timely manner.
• Participate in Global API meetings to assess cross-functional impact of changes and define implementation plans and strategies as required.
• Execute projects based on Global API priorities established by the Global API management team.
• Identify needs and implement improvements for Global API processes and participate in the regular review and revision of existing SOPs to ensure accuracy and compliance.
• Preparation of reports and presentations for senior management review.
• Engage effectively with the Global API Sourcing Hubs in communicating with various suppliers to get submission documents, resolve technical problems, including regulatory compliance for both NPD and PLCM sources.

• Represent GAPI as requested by Apotex internal groups regarding issues pertaining to API, so that these problems can be efficiently addressed with the supplier.

• Lead by example, demonstrating the values of Collaboration, Courage, Perseverance and Passion to positively influence the shift towards a Quality Culture.
• Perform all duties and responsibilities in accordance with established GMP/cGMP operating procedures and safety standards.
• Perform additional duties as required.

Job Requirements

• Education
  • B.Sc. or B. Eng. in Chemistry, Pharmaceutical or Health Sciences required.
  • Knowledge, Skills and Abilities
  • Must possess knowledge of the technical, quality, and regulatory issues related to the API life cycle management (DMF review, regulatory updates, operations and cost evaluations) and qualifying of a drug substance.
  • Must possess the ability to provide explanations or solutions to a variety of problems of moderate scope and complexity.
  • Ability to read and interpret complex technical documents (DMF, Specifications, test methods..etc). Ability to write detailed business correspondence.
  • Excellent communication and interpersonal skills.
  • Strong organizational skills; ability to work independently and manage priorities
  • Strong leadership skills.
• Knowledge of and experience with the MS-Office suite of products.

• Experience
  • 3 - 5 years of relevant experience in a pharmaceutical industry preferred.

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.