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Manufacturing Technical Services Manager

Date: Jan 8, 2021

Location: Richmond Hill, ON, CA, L4C5H2

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

 

The Manufacturing Technical Services Manager is responsible for  the overall leadership and oversight of Production Investigations, Complaints and the execution of Manufacturing Technical Services (MTS) strategies. The successful candidate will be responsible for ensuring  all production investigations (complaints, deviations, incidents ) are investigated and documented in a manner which ensures compliance with all applicable GMP’s. In addition, this role supports the technology transfer of new products from R&D into commercial operations, post launch process performance monitoring and optimization continuous improvement. The role ensures alignment with business strategies and meeting industry compliance requirements and  builds collaborative cross functional relationships with R&D, Manufacturing, Commercial, Quality, Supply Chain, New Product Launch, Procurement, Regulatory Affairs, Human Resources and Finance.

Job Responsibilities

 

  • Ensures all deviations and complaints are properly investigated leading to root cause & corrective action determination.  Oversees generation of metrics for deviations, incidents, identifies trends & develops action plans to mitigate risks.
  • Ensure the department is a “compliant” state with regards to safety & cGMP requirements.
  • Supports process development & optimization, product & equipment characterization to ensure robust process capability. Develops ,recommends & implements changes to SOPs.
  • Support the Technology Transfer for new products to ensure that they are successfully scaled-up to meet commercial process & throughput requirements, launched & transferred to the production facility
  • Ensure process robustness & validation status of products is monitored through process qualification & throughout the lifecycle of the products
  • Supports post-commercial product including Product Life Cycle Management (PLCM), API or excipient source changes, production support related to troubleshooting on the shop floor, process capabilities, product remediation, changes to process & technical process issues.
  • Demonstrates strong decision-making skills, utilizing all available resources to be proactive in implementing the proper approach.
  • Ensure the decision making process for MTS projects includes appropriate technical & regulatory due diligence to ensure that projects are executed based on priority & in a coordinated program.
  • Ensure that harmonized & compliant policies & practices are in place pertaining to investigations (SWAT, OOS, OOT, Customer complaints & all other batch related investigations)
  • Develops, justify & manages budget & be accountable for variances. Develops & recommends long term plans.
  • Establish a strong technical & efficient team proficient in various unit operations, process troubleshooting & optimization,& investigative skills
  • Build a strong working team with the Manufacturing & Quality functions to lead continuous improvements.
  • Responds to complex queries from internal & external customers providing technical expertise relative to their area, & ensuring that advice provided is in compliance with SOP’s & external standards
  • Participate & lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support & remove barriers; &, communicate & revisit performance expectations to reinforce & encourage high performance culture & a safe working environment for all employees.
  • Utilize open, honest, two way communication to build trust-based relationships with employees, business partners & direct leader while continuously improving leadership capabilities by personally seeking feedback & development.
  • Create a culture which values trust & provides the opportunity for Employee development & growth in pursuit of our purpose & demonstrating our core Values – Collaboration, Courage, Perseverance & Passion.
  • Utilize your networks to attract & hire talent in a comprehensive, differentiated & consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values & commitments made to candidates during the hiring process.
  • Ensure adherence of team members (direct reports) with all compliance programs & company policies & procedures.
  • All other duties as assigned.
     

Job Requirements

 

  • A Bachelor of Science Degree, , Pharmacy, Pharma Technology, Engineering, Chemistry or related science.
  • Minimum 8 years’ experience with proven capital and technical leadership capabilities.
  • Experience in the pharmaceutical industry is required for this role; working knowledge of liquid dosage processes would be a definite asset.
  • Experience with knowledge transfer, scale up and validation.
  • Strong experience with process improvement.
  • Understanding and knowledge of regulatory guideline.
  • Strong organizational skills and communication skills.

 

 

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.