Loading...
 

Active Pharmaceutical Ingredients (API) Manager

Date: Jan 8, 2022

Location: North York, ON, CA, M9L 1T9

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

 

In this role, the incumbent’s responsibility is to manage the API (drug substance) life cycle management which mainly includes Supplier Driven changes (SDC) management and New source qualifications. Also work directly with the appropriate functional groups within Apotex, internal API manufacturing sites and external manufacturers on technical, quality, and regulatory issues for new product development (NPD) and Commercial products related to active pharmaceutical ingredients (APIs) and excipients.

Job Responsibilities

 

  • Working with the SDC Project Leaders and Coordinators as well as the cross-functional team, efficiently manage the intake, assessment, and processing of SDCs for Apotex sites.
  • Participate in cross-functional team meetings for raw material alternate source evaluation and qualification in accord with the priorities and targets of the Apotex Odyssey Lite program and report regularly on the status of these projects to Global API leadership.
  • Conduct comparative data review on new and alternate API suppliers for input to decisions on source selection. As well, communicate with suppliers directly and via the Global API Hubs on facility, equipment and capacity to ascertain the processing capability of suppliers.
  • For selected projects, work closely with Apotex’s groups (AO, TO, RA, etc.) and manufacturers for all quality related investigations (OOS/OOT, etc.) and trend analysis to identified risk on failure.
  • Liaises with the API sourcing hubs and API evaluation sites on testing of evaluation samples provided by various API suppliers.
  • 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 or participate in initiatives for the improvement of internal processes that affect API supplier qualification or API release (e.g. SOP, sharing of data, methods and specification development, OOS investigation processes etc).
  • Leads with a global cultural mindset to ensure compliance of team members (direct reports) with the Global Business Ethics and Compliance Program, Global Quality procedures, Safety & Environment and HR policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment).
  • Recruits, trains, develops and performance manages their direct reports, including regular one-on-one meetings, probationary and mid-year performance discussions.
  • Ensuring all Job Descriptions for reports are periodically reviewed, signed and stored per our global processes
  • Providing coaching, feedback and recognition based on the expected behaviours and performance, updating development plans and ensuring that all are properly trained and qualified according to our Global Training and Employee Qualification Enterprise Policy.
  • Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion.
  • All other duties as assigned.
     

Job Requirements

 

  • BSc. or B. Eng. in Chemistry, Pharmaceutical or Health Sciences required.
  • 15 years of experience in the pharmaceutical industry; experience with API manufacturing and project management is preferred.
  • Minimum 5 years of Supervisory experience required.
  • Possesses knowledge of the technical, quality, and regulatory issues related to the qualifying of a drug substance.
  • Possesses the ability to provide explanations or solutions to a variety of problems of moderate scope and complexity.
  • Ability to interpret complex technical documents and write detailed business correspondence.
  • Excellent communication and interpersonal skills.
  • Strong leadership and organizational skills; ability to work independently and manage priorities
  • Knowledge of and experience with the MS-Office suite of products.

COVID-19 VACCINATION POLICY: In accordance with Apotex Inc. (“Apotex”) policy, as of November 15, 2021, all individuals entering a Canadian site (including but not limited to employees, visitors, contractors and agency workers) must be fully vaccinated against COVID-19 in accordance with the current government requirements.  Further, all employees must maintain all future booster vaccines as approved and recommended by Health Canada.  Accommodation from these requirements for reasons pursuant to the Ontario Human Rights Code, or any other applicable law (most commonly for medical and/or religious reasons) will be reviewed and considered by Apotex.

 

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.