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Technologist, Manufacturing Technical Services

Date: Jan 13, 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

Technical Support Services is responsible for identifying, proposing and implementing modifications to existing commercial products in order to improve their quality and/or efficiency of manufacture.  Technical Support Services works closely with Procurement, Planning, Manufacturing, Quality and R&D in order to ensure that products are restored in a timely manner to routine manufacture in a safe, compliant and efficient state.  Technical Support Services also evaluates changes to, or new sources of Active Pharmaceutical Ingredients (APIs) and excipients for use in the manufacture of existing commercial pharmaceutical products.
 

Job Responsibilities

• Collects information and evaluates issues with, or changes to, the manufacture of existing and new commercial products. Proposes investigation and remediation plans to Scientific Leader.
• Evaluates proposed changes to API sources as well as new sources of APIs for existing commercial products.  Writes evaluations, using appropriate formats as required, including recommendations for further actions in conjunction with the Scientific Leader.
• Develops detailed investigation and remediation plans then drafts protocols which govern their execution in conjunction with Scientific Leader.
• Performs risk assessments at appropriate stages through the investigation, evaluation and remediation process.  Incorporates the results into protocols and reports as appropriate.
• Prepares or marks up documentation necessary in order to execute trial, optimization or demonstration batches.
• Organizes, coordinates and supervises the execution of trial, optimization or demonstration batches.
• Operates under the guidance of Scientific Leader or Project Manager.
• Writes reports on evaluations or investigations into process issues and on the outcomes of investigational trials.
Communication
• Communicates and builds relationships with various stakeholders including Managers and Directors.  Presents solutions and solicits feedback from Senior Management groups.
• Responsible for writing protocols and reports in support of projects.
Interpersonal Skills
•  Works collaboratively with others in the same department and with direct stakeholders to achieve agreed objectives. Escalates issues as necessary.
Technical Capability
•  Utilizes a good level of operational knowledge of solid dose products and their manufacturing processes to add value to investigations, evaluations and recommendations.
• Understands the correct operation of Production equipment and adequately identifies and diagnoses complex operational issues.
• Demonstrates working understanding of regulatory guidance requirements discusses them with Regulatory Affairs.  Accurately incorporates regulatory requirements governing proposed changes into written documents.
• Collects and appropriately formats data. Utilize standard statistical tools for analysing process data from investigational trials and commercial manufacture.
• Understands and interprets standard laboratory test results in the context of their projects.
Compliance and Due Diligence
• Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities;
• Works as a member of a team to achieve all outcomes;
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion and
• All other relevant duties as assigned.
 

Job Requirements

• Education
o College / University degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering or related science.
• Knowledge, Skills and Abilities
o Knowledge of the operational principles of pharmaceutical manufacturing equipment and processes.
o Good verbal English communication skill sufficient to present ideas and proposals in small peer group settings.
o Good document and report writing skills, capable of conveying information and proposals logically, clearly and unambiguously.
o Good computer skills for Microsoft Office (Word, Excel, PowerPoint, Outlook and JMP). 
o Capable of interrogating/finding data in Apotex standard computer systems (SAP, LIMS, Validator, AQRS/QMS).  Qualified to make standard entries in SAP and QMS systems.
o Capable of completing project assignments with minimal supervision and good time management, escalating for clarification or decisions as necessary.
o Good knowledge of GMP principles and practices, as applied through company procedures.
• Experience
o Minimum of 2 years relevant working experience in the pharmaceutical or related industry, ideally with experience in solid dose development or manufacture.

 

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.