Scientific Leader, Pkg Dev-GRD-LDPF R

Apotex
Posted

Post Expires

Type

Executive / senior industry position

Scientific Leader, Pkg Dev-GRD-LDPF R

Company: Apotex

 

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

 

Job Summary

The Scientific Leader, Packaging Development is responsible for all the activities leading to the development of primary and secondary packaging components for a large variety of liquid dosage forms for new products at Richmond Hill. The Scientific Leader, Packaging Development also provides technical supports and solutions for issues related with packaging for commercial products

 

  1. Evaluate primary packaging components for all new products under liquid dosage portfolio
  2. Provide justification and select the most suitable primary packaging for new products based on the packaging evaluation data and consideration of other associated factors
  3. Work with related departments to develop secondary packaging for new products
  4. Liaise with packaging vendors to resolve any technical issues and ensure the project timeline on track
  5. Design and execute the primary and secondary packaging studies
  6. Verify the primary package capacities such as minimum fill and headspace
  7. Conduct technical communications with package vendors such as review and     approval of the drawings
  8. Develop the process parameters and physical specifications for new primary and secondary packaging components
  9. Ensure label and primary packaging information are accurate for NPD products in Technical Transfer Template(TTT)
  10. Provide packaging information to Regulatory Affairs Department for submissions and answer related deficiency questions from various agencies
  11.  Assess commercial line feasibility for new primary packaging
  12. Support Production Engineering and Validation Departments for packaging line trials, commissioning studies and PQ’s on commercial equipment
  13. Create and maintain test methods and SOPs relating to primary packaging development
  14. Coordinate packaging change communications with Marketing, Operations, Validation, QA and RA departments
  15. Provide Technical trainings and is responsible for packaging testing and evaluation reports
  16. Liaise with graphic group for post approved drug product label changes
  17. Recruit, train, develop and manage effectively the ongoing performance of direct report
  18. 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).
  19. Work as a member of a team to achieve all outcomes.
  20. Perform all work in support of Apotex Corporate Values of Pride, Accountability, Integrity and Diligence; demonstrates strong and visible support of our values.
  21. Ensure perform all work in accordance with the established regulatory and compliance and safety requirements
  22.  Perform all other duties as assigned

 

  • Over 5 years of packaging working experience in a pharmaceutical research and development environment.
  • Excellent hand-on working experience and scientific sounded knowledge of packaging configurations and materials.
  • Strong verbal and written communication skills.
  • Ability to make responsible and accountable decisions.
  • Excellent organization and report writing skills.
  • Experience using computers, preferably in Microsoft Office (Word, Excel, Access, PowerPoint and Outlook).
  • Well-developed interpersonal and team skills.
  • Knowledge of GMP, GLP, Safety, FDA and TPD guidelines.
  • Multi-tasking and project management 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.

 

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More Information

Posted

Post Expires

Type

Executive / senior industry position

Richmond%20Hill%2C%20Canada

Richmond Hill , Canada