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Job Detail

Senior Manufacturing Sciences Specialist

Job Summary

Location

Laval QC

Posting date

Industries

  • Pharmaceutical, Biotechnology

Categories

  • Engineering
  • Facilities and maintenance
  • Information Technology
  • Operations (manufacturing, packaging)
  • Production and planning management
  • Quality assurance and control - Validation

Prometic Bioproduction inc. ("PBP") undertakes the development and manufacture of high-value plasma-derived therapeutic novel and biosimilars for Prometic's current and future clients in a state of the art facility.

 

Prometic Bioproduction Inc is experimenting a substantial growth. In order to support operations expansion, the Senior Manufacturing Sciences Specialist will be responsible for providing support to the Manufacturing Science Manager for all activities related to plasma-derived protein manufacturing process: technology transfer, scale up to the manufacturing scale and process validation. More precisely, the incumbent will develop projects using solid scientific and processing expertise for new and established protein purification processes. Solid documentation practice and communication skills will serve at creating necessary protocols, reports, Department SOPs and batch records for processing of drug substance and drug product.

The incumbent will be asked to conduct Risk assessment, determination of critical process parameters, definition of control strategy, process scale-up, trouble-shooting activities, overview and/or participation to protocol execution, investigations, and to participate to the preparation of regulatory submission sections.

 

The mandate of the Senior Manufacturing Sciences Specialist will include:

 

  • Lead technology transfer, process scale up projects and facility fit for manufacturing processes of bulk drug substances and drug products.
  • Assess risks for the quality of current products and products in development.
  • Develop and participate to engineering runs preparation, execution and performance reports.
  • Act as a person-in-the-plant to overview outsourced manufacturing activities.
  • Lead process validation based on FDA guidance for protein purification processes and fill finish process of injectable drugs.
  • Represent the department as a subject matter expert in protein purification and related analytics during investigations.
  • Other related duties/responsibilities as required or assigned by the manager.

 

The selected candidate must hold a Master of Science in Chemistry, Biochemistry, Biology or in a related field with a minimum of ten (10) years knowledge and working experience with all aspects of manufacturing sciences related to protein purification and formulation. Relevant R&D experience with biologics or biotechnology derived products.   Experience in developing manufacturing process for biologics.  Experience with Quality Risk Management and Associated tools (FMEA, HACCP).  Solid comprehension and use of analytical assays to guide protein-based process development.  Knowledge and understanding of Canadian, US FDA, European and ICH regulations and guideline on Quality.  Excellent knowledge of English (oral and written) and French (oral).  Ability to operate both independently and in cross-functional teams including qualified professionals of other departments.

Other requirements:  Computer and software skills (Excel, Word, Outlook or equivalent). Knowledge of basic statistics tools and knowledge in design of experiment (DOE).

Prometic offers a competitive compensation, a flexible work schedule and a casual working environment.

To apply, please send a cover letter and copy of your resume to hr with the following reference: PBP-MS-1701. Prometic is an equal opportunity employer. Only chosen candidates will be contacted for an interview.  For more information about Prometic, visit our website www.Prometic.com.