Director, Manufacturing Sciences

January 14 2019
Industries Pharmaceutical, Biotechnology
Categories Engineering, Pharma, Biotech, Sciences, R&D, Biological - Life Sciences - Genetics, Pharmaceutical, Scientific and Regulatory affairs, Chemistry, Project management, Laboratory, Research and development
Laval, QC

At Prometic, over 450 people work at saving lives, one role at a time. Located at the heart of the Cité de la Biotech in Laval, our Prometic Bioproduction Inc. division is blooming as we are currently developing a treatment for orphan diseases affecting children, made of plasma-derived proteins. Our treatment will allow these children to have a new pathway to hope.

To contribute to this revolutionary and innovative project, we are looking for a Director, Manufacturing Sciences, who will be responsible for providing strong leadership, scientific knowledge and technical expertise for all aspects of process scale-up, process monitoring, and process troubleshooting as well as supporting technology transfer of drug products ranging from small scale up to commercial manufacturing.

The Director, Manufacturing Sciences will be responsible for:

  • Inspiring and managing a team of 8 professionals dedicated to the development of new protein products and processes, including leading risk assessments in support of new product implementation and providing direction and significant technical input for initiatives to establish multi-product manufacturing capability;
  • Providing technical leadership and direction for process monitoring and statistical analysis of commercial manufacturing operations. Reviewing and ensuring the reliability of technical data related to formulation, process, analysis, and stability monitoring for new products and processes to be included in IND, NDA, and ANDA eCTD submissions;
  • Managing and providing guidance for technical transfer and continuous improvement projects throughout the product lifecycle using technological innovation and alignment with regulatory and commercial manufacturing requirements;
  • Providing significant technical depth to support troubleshooting efforts and lead high-level deviation investigations in conjunction with Process Development, Manufacturing, and Quality;
  • Providing technical input to Process Development for defining the critical process parameters of new processes and to Validation in developing process validation protocols;

 

You are the right person for this role because:

  • You hold a PhD in science (biotechnology, biochemistry or related fields);
  • Biopharma has no secrets for you since you have a minimum of fifteen (15) years of experience in protein purification, process implementation, process development and optimization, scaling activities and products transfer within the industry;
  • You have developed several manufacturing sciences experts through your ten (10) years' experience in a managerial role;
  • You have a thorough knowledge and understanding of Canadian (Health Canada), American (FDA) and European (EMEA) regulations, as well as experience with cGMP and ICH regulations and guidelines following your participation in product launches;
  • You can communicate in French.

Prometic offers you:

  • A fantastic team who strives at doing things in the best possible way;
  • A casual environment;
  • A « start-up » culture that values autonomy, innovation and collaboration;
  • A competitive salary and benefit package, which includes participation in shareholding program;
  • A unique opportunity to change lives through your commitment and contribution.

Send us your resume right away to: **@********.com with the reference PBP-MS-DIRMS.

The usual fine lines:

Prometic is an equal opportunity employer.  For more information about Prometic, visit our website  www.prometic.com.

Apply now!

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