Executive - API Technical

Job Summary

In this role, the incumbent will liaise and work directly with the appropriate functional groups within the Apotex group of companies and external raw material manufacturers on technical, quality, and regulatory matters for New Product Development (NPD), Product Life-Cycle Management (PLCM), and Commercial Projects related to active pharmaceutical ingredients (APIs) and excipients. Responsible to provide a high level of expertise with regards to drug master file (DMF) review, DMF deficiencies, DMF changes, also known as supplier driven changes, raw material out-of-specification (OOS)/out-of-trend (OOT) events resolution between Apotex and its suppliers.

This involves:

• Driving the technical aspects of raw material sourcing projects in the region or problem-event resolution by defining, planning, monitoring and reporting project progress/performance against timelines and deliverables.
• Updating the Sourcing Hub Leader, Global API Technical Managers and other stakeholders on project progress.
• Focusing on the end goals of delivering API technical assessments and problem resolutions with suppliers in the sourcing region.

Job Responsibilities

• Ensure that Apotex achieves the most rapid approval on drug product submission dossiers, the incumbent with be the lead reviewer for sourcing region originated DMFs (open-part and closed-part, when available)
• Ensure that the supplier DMFs conform to the most current requirements of the filing jurisdiction, for example, ICH guidelines (Q3, Q11, M7 etc.), with special attention to the most recent regulator mandated filing requirements
• DMF review must extract and disseminate relevant information needed to assist formulation development, setting of appropriate drug substance specification, and shipping and storage of materials
• Contribute to and manage response plans with manufacturers and Apotex internal groups for DMF deficiency responses, so as to not disrupt application approval timelines or the material supply chain.
• Manage the coordination of NPD and PLCM projects and process/manufacturing site changes between the sourcing region suppliers and GAPI Site Technical teams (and when required, directly with Apotex Analytical Development, Regulatory Affairs, and Formulation Development) to ensure a seamless submission process
• Coordinate the data (OOS investigation, rejection, OOT investigation, CAPA, etc) and information flow between suppliers and GAPI Site Technical teams and/or quality assurance teams for all quality and technical initiatives (Nitrosamine, Allergen, Forced degradation, Stability data, etc) quality related investigations surrounding active ingredients and excipients from the regional hub’s portfolio.
• Working with suppliers, investigate and resolve technical, quality, and regulatory issues related to active ingredients and excipients for NPD, PLCM and Commercial drug products with regard to OOS events, Certificate of Analysis (CofA) discrepancies, documentation for impurities and active standards, manufacturing process changes or site relocations, DMF deficiencies, DMF changes, and specification changes, method alignment
• Coordinate specifications revisions (monograph updates or new project status), as well as industry initiatives, between Apotex and raw material suppliers
• Assist the Global API manufacturer selection process for NPD and PLCM projects through cross-functional communication with the technical teams at the GAPI regional hubs and GAPI site teams
• Contribute information content to GAPI supply databases as required. Maintain the Apotex SharePoint database for DMF and DMF annual updates for the regional hub portfolio
• Perform all other tasks and duties as may, from time to time, be assigned (for example, Confidentiality Disclosure Agreements with suppliers)
• All other duties as assigned.

Job Requirements

• Education:
  • Graduate/ Post Graduate in Science/ Commerce, Economist (Business Administration) or Scientist (Chemistry, Chemical engineering, Pharmacology etc.)
• Knowledge, Skills and Abilities
  • Must possess knowledge of the technical, quality compliance, and regulatory requirements related to the sourcing of APIs.
  • Must possess the ability to provide solutions to a variety of problems of moderate scope and complexity.
  • Ability to read and interpret complex technical documents. Ability to write detailed business correspondence.
  • Ability to work with managers or directors and communicate ambiguous concepts.
  • Excellent communication and interpersonal skills.
  • Strong organizational skills; ability to work independently and manage priorities.
  • Demonstrated knowledge of the generic API new product development process
  • Ability to travel to supplier sites or industry trade conventions when required.
  • Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS Outlook and MS-Excel. Willingness to learn and become proficient with new business software applications as they are introduced to the organization.
• Experience:
  • 8 - 10 years of experience in the pharmaceutical industry.