Apotex Inc. TO Technical Support Services Scientific Leader in Etobicoke, Ontario

About Apotex:

Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!

We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds. We’d love to hear how you could contribute to the team!

Job Summary:

Responsible and accountable for competently supervising subordinates in accordance with the Ontario Occupational Health and Safety Act, Apotex Health and Safety policies and Safe Work Procedures (SWPs). Provide all required training, equipment, tools and follow procedures in accordance with the Safety Charter, attend departmental audits and follow up on corrective actions within prescribed timelines.

Responsible for the supervision of and providing assistance with technical support projects for the improvement of new and current product formulations and processes, launch and demonstration batches, to ensure the manufacture of high quality products, and the use of efficient manufacturing processes at all Apotex sites.

Job Responsibilities:

  • Investigates formulation and process deficiencies for current products being manufactured in order to determine the causes and to recommend and implement solutions for improvement.

  • Develops, recommends and provides technical support to experimental trials in order to evaluate changes in formulations, raw materials, and manufacturing processes.

  • Perform complex problem solving and decision making tasks on floor. Provide solutions and suggestions for technical problems encountered by team members.

  • Initiate and conduct the investigation for all out of specification results and product manufacturing chronic issues. Utilizes advance problem solving techniques and tools to identify root causes and determine course of action.

  • Provides technical support to QA for investigation, Regulatory affairs with product submission documentation for all major process changes.

  • Anticipates how multiple activities come together and orchestrate to accomplish a common goal and consistently achieves deliverables.

  • Monitors and supervises the full-scale manufacture of products, as required, to provide technical support and/or technology transfer to the manufacturing departments.

  • Writes investigational reports, project summaries, project updates, and provides recommendations, as required.

  • Responsible for training, providing guidance to and overseeing Technician and Technologist in Technical Support Services regarding the performance of their activities. Assists Manager in performance reviews.

  • Screens and evaluates data (e.g. Dissolution, assay, and content uniformity) on trials, and makes recommendations for stability batches and out of specification results on validation batches.

  • Identifies new techniques, processes and technologies and make recommendations to the next level.

  • Possesses a detailed understanding of the theoretical principles for major manufacturing processes, as applied by the equipment used in the manufacturing process.

  • Designs, issues and evaluates trials to develop robust manufacturing processes.

  • Tests the ruggedness of the formulae by conducting suitable trials to vary the excipient within SUPAC guidelines.

  • Evaluate data using statistical tools for the validity of results for implementation.

  • Responsible for the preparation of documentation and obtains the necessary approvals to support Change Control Forms to change the Master Formulae of Production, SAP Recipes and Certificates of Analysis.

  • Communicates directly, assertive and diplomatic with all levels of the organization and with internal / external contacts.

  • Responsible for investigation and root cause determination of Quality Notifications and review of draft Master Formulae issued by Technical Support Services.

  • Provides support for Medical information department about customer queries.

  • Responsible and accountable for troubleshooting and resolving challenges during the manufacture of pharmaceutical solid dosage forms at all Apotex sites.

  • Applies strong analytical and proactive problem solving skills and involves others.

  • Anticipates problems and interruptions and develops contingency plans to accurately scope out length of task / project.

  • Use advanced techniques to identify root causes of issues with proposed formulation and processes, and plan a course of action for further investigation and corrective action as required.

  • Uses advanced problem-solving techniques to assess equipment and processes for optimal use, and to arrive at best practices for projects under development.

  • Investigates complex issues, and implements new or unconventional research techniques when conventional techniques fail.

  • Responsible and accountable for decisions made to eliminate problems in Production.

  • Accountable for all changes in deadlines, project deliverables and other areas when making decisions.

  • Reviews scientific literature, attends appropriate training, seminars and presentations to maintain expertise in formulation development, manufacturing equipment and processes, raw materials, pharmaceutical technologies, and related areas.

  • Takes a lead role in offering value added services and innovative solutions and seeks out and implements tools to help the team achieve expectations and goals.

  • Provides professional expertise and performs consultations on issues regarding process optimization to other members of Technical Support Services department and other departments.

  • Establish the work plan and assign work activities to team members, following up to ensure its completion in compliance with regulations.

  • Review or approves the documents (MMD, Trial protocol, Trial reports, validation protocols/ reports, CCP’s et al.) to ensure the compliance with SOPs, cGMP, GDP and Technical Manuals.

  • Recruit, train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:

  • Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually,

  • Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties,

  • Providing coaching, feedback and recognition,

  • Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment).

  • Works as a member of a team to achieve all outcomes.

  • Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.

  • Performs all work in accordance with all established regulatory and compliance and safety requirements.

  • All other duties as assigned.

Job Requirements:

  • College/University degree in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical Engineering or related science

  • Minimum of eight years successful working experience in the pharmaceutical industry with related experience in formulations development of solid dosage forms, scale up and/or technology transfer.

  • Extensive knowledge and experience in pharmaceutical processes and equipment

  • Strong verbal and written English communication skills

  • Excellent organization, troubleshooting and report writing skills

  • Intermediate to Advanced level of computer skills in Microsoft Office (Word, Excel, PowerPoint and Outlook)

  • Well-developed interpersonal and team skills

  • Multi-tasking and project management skills

  • Ability to work independently and make responsible and accountable decisions

  • Capable of issuing and investigation of Quality Notifications and CCFs in SAP (Master Formulae, SAP Recipes and Certificates of Analyses)

  • Thorough understanding and knowledge of cGMPs, GLP, SODs, SWPs, USP, BP, EP SUPAC, FDA and HPFBI guidelines.

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.

System ID: 2016-4920

Job Type: Full Time

Career Level: Experienced

Years of Experience: 8