Project Manager, Technical Transfers

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Position Summary

The Project Manager, Technical transfers is responsible for managing technical transfers of manufacturing process and analytical methods between sites. He is also responsible for technical service projects as troubleshooting of manufacturing operations and development of analytical methods. He manage technical services activities related to troubleshooting of manufacturing process, analytical methods development / validation, authoring of study reports, review of validation protocols and reports, risk assessment, product life cycle management.

Although this position can be filled remotely, a minimum of one day per week in the office is required

Reports To

Director, Research & Development

Specific Responsibilities- Coordinates and liaises of internal and external teams to ensure flowless communication: acts as the central point of communication for the Tech transfers and the Tech Services projects.- Monitors compliance with deliverables, timelines, and budgets.- Organizes project meetings, issues agenda and minutes, follows up on action items with the stakeholders.- Collects info to build project plan: including owner info, duration, lag time, budget, risks, and prerequisite tasks- Monitors progress of the Tech Transfers and Technical Services projects with Gantt Charts (elaboration, revisions)- Manage contract elaboration: review technology transfer service agreements, assist with Master Supply Agreements, communicate with Contract Manufacturing Organization (CMO), legal department and external laboratories.- Presents reports on project status including scorecards (budget, timelines, risk assessment and solutions to mitigate those risks).- Work with Supply Department for scheduling of the validation batches related to Tech Transfers, shipment of the validation batches/samples to CMO/labs, freight estimates, drop-shipment, price estimates, raw materials and packaging components- Troubleshooting manufacturing process and analytical methods in providing technical feedback and recommendations related to solid, liquid, semi-solid and sterile dosage form- Revision of technical documentation: study protocol/report, process validation protocol/report, analytical method validation protocol/report- Provides scientific rationales, study reports, risk assessment, FMEA- Dynamic and enthusiastic- Initiative and follow through- Excellent interpersonal skills- Team oriented- Analytical skills- Multitasking and ability to prioritize- Problems solving- Well organized- Negotiation skills- Ability to communicate with stakeholders for all levels of management- Well-refined people skills- Able to work under time constraints/ pressures- Willing to travel occasionally to CMOs within Canada

Required- Bachelor’s degree in Sciences (Chemistry or pharmaceutical sciences preferred) or a relevant discipline- 2-4 years of experience in pharmaceutical industry in project management- Experience in troubleshooting in Technical Services and/or R&D pharmaceuticals projects (Finished products, API, packaging)- Project Management skills in Tech Transfers and in Technical Services of pharmaceutical products- Good knowledges on Microsoft Project 2016, MS Server 2016, Coupa, SAP, Minitab and Onepager pro.- Excellent knowledge of written and spoken English and French allowing for a fine review of documents and clear presentations

Asset- Experience in Tech transfers between manufacturing sites of solid, liquid and semi-solid dosage forms- Experience in pharmaceutical project management of tech transfers between sites and in technical services projects- PMP certified- Lean Six Sigma

Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.