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Reporting to the VP, R&D and Technical Operations and as a member of the management committee, the Pharmaceutical Development Director manages the operational portion of all activities and resources (financial, material, human) of the R&D, Technology Transfer (TT) and Specifications (Specs) divisions of the Technical Operations Department. He facilitates communication between R&D, TT and Specs as well as with other Confab departments. He assures communication with the client on all issues related to these departments. He has under is responsability ten employees.
- Assess the feasibility of new projects;
- Provide costs for R&D portion of bids, development and TT projects in collaboration with stakeholders;
- Monitor general progress of formulation projects, as well as technology transfer and management of spécifications;
- Ensure sustainability of R&D Projects Plan and approve documents related to current projects, as required;
- Take responsibility for resolving operational and technical issues that compromise progress or billing of R&D and TT projects;
- Identify and manage the necessary resources (personnel/skills, equipment and material) required to achieve corporate and division objectives;
- Develop the department's budget and monitor expenditures and project cost-effectiveness through the R&D and TT P&L;
- Identify and monitor key performance indicators (KPI);
- Ensure regulatory compliance for R&D and TT activities;
- Participate in various regulatory and client audits;
Master’s degree or Ph.D. in Pharmacy, Engineering, Chemistry or other relevant science;
8-10 years’ experience in pharmaceutical development (formulation and process) in a pharmaceutical company;
Minimum 5 years' experience in a management position (human, material and financial resources) ;
Good knowledge of the development steps required for the submission and approval of regulatory files to the FDA, EMA and Health Canada.
Excellent knowledge of regulations related to good manufacturing practices (GMP) and site transfers.
Inspiring and motivating leadership skills, initiative, power to influence, ability to work independently, organizational skills and sense of responsibility.
Sense of urgency, ability to manage several projects at the same time, ability to handle tight deadlines.
Confab Laboratories is part of Mylan Pharmaceuticals ULC, one of the largest pharmaceutical companies in the world with over 35,000 employees across 165 countries.
Confab specializes in the development and manufacturing of non-sterile pharmaceutical drugs (CDMO). The plant, located on the south shore of Montreal, is growing with major expansion investments underway to support an increasing volume of R&D projects as well as pioneering new dosage forms.
The company complies with both Canadian and US regulatory requirements. To know more about Confab Laboratories please visit the website at http://www.confab.com/
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