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Manufacturing Science and Technology Specialist

3 months ago

Calgary, Canada Providence Therapeutics Holdings Inc Full time

At Providence Therapeutics, we Ignite the Cure Within. We are a clinical stage Canadian mRNA company focusing on getting the best quality vaccines to the places that need it most. These include infectious disease, animal health, gene editing, and oncology. We are on the leading edge of vaccine development and are on the hunt for people with an adventurous mindset to join us. We want to make a difference and help heal the World.

We have an immediate opening for a Manufacturing Science and Technology (MSAT) Specialist. This position is based in Calgary, Alberta.

How we plan to keep you busy:
  1. Implement our lipid, drug substance, and drug product MSAT strategy.
  2. Serve as Providence representative in day-to-day communications, with our CMOs/CDMOs as it relates to the manufacture of our lipids, DS, and DP batches, objectives, and function as Person in Plant as necessary.
  3. Lead the tech transfer, scale-up, and process improvements of lipids, mRNA-drug substance, and drug product.
  4. Offer leadership to core project team(s) by building and motivating.
  5. Lead/oversee the generation of technical documents including Master Production Records, SOPs, development reports, manufacturing instructions, and investigation reports.
  6. Work with the Quality unit to investigate and document deviations in a timely manner, as appropriate.
  7. Aid in the development and maintenance of key project performance indicators for CMO/CDMO specified metrics, ensuring that the KPIs are within the scope of the project contract.
  8. Prepare and deliver presentations describing project progress and technical issues.
  9. Assist with compiling and authoring CMC sections of regulatory submissions.
  10. Manage the manufacturing activities, equipment status, and clinical supply production at CMOs.
  11. Coordinate the generation of technical documents including Master Production Records, SOPs, development reports, manufacturing instructions, and investigation reports.
  12. Prepare and deliver presentations describing project progress and technical issues.
  13. Champion continuous improvement initiatives throughout the organization.
  14. Take the initiative to establish effective collaborations across clinical development, regulatory, CMC development, manufacturing, and supply chain team.
What will help you get here:
  1. Bachelor’s degree in a scientific discipline is required, an advanced degree is preferred.
  2. 4+ years experience in pharmaceutical CMC experience, including technology transfer and management of contract vendors.
  3. Proven ability to work effectively in a team environment within a diverse organization and have a high level of independence for planning and executing project requirements.
  4. Ability to work on complex problems in which the analysis of situations or data requires an in-depth evaluation of a range of factors.
  5. A demonstrated desire to embody the Providence core values (Initiative, Connection, Integrity, Accountability, and Innovation).
What it’s like to work with us:

At Providence Therapeutics, you’ll be working with a clinical Canadian Bio-Tech company that is innovating in the fast-growing mRNA space. We are focused on helping and healing people around the world. We are looking for culture builders and visionaries to help us make our COVID-19 and Cancer programs a reality. You truly have an opportunity to have a positive impact on individuals’ lives.

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