Specialist Technology Transfer

March 26 2019
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs, Operations (manufacturing, packaging), Research and development
Montreal, QC

What Omega offers you!

  • A nice team
  • Group Insurance
  • Group RRSP with contribution from employer
  • Public transportation and train nearby

Main functions:

  • Support the Manager in technology transfer activities including manufacturing and packaging of batches from internal or external customers;
  • Attend the writing of the production and packaging files;
  • Participate in the optimization and / or adaptation of manufacturing processes during technological transfers including the conduct of tests at the pilot laboratory or production scale;
  • Support the Manager for the production of feasibility and characterization batches when introducing new products in production in partnership with the various groups involved;
  • Support production and evaluate impact when determining / changing pilot and commercial lot sizes.
  • Participation / support to the writing of:
  • Method transfer reports / validations;
  • Annual reviews;
  • Change controls;
  • Carry out and document the investigations in partnership with the groups involved;
  • Contribute to problem solving during technology transfer activities; Provide monthly reports (KPIs).

Required skills :

  • Bachelor's degree in chemistry, chemical engineering or related field
  • 3 to 5 years of experience in manufacturing, formulation, process development and analytical laboratory;
  • Practical experience with the operation of pharmaceutical production equipment (weighing, blending, bagging, wafer setting and bottling);
  • Experience writing change controls, protocols and reports, and implementing related action plans;
  • Experience in creating and approving manufacturing and packaging records.
  • Bilingualism (French, English) both oral and written;
  • Organization, meticulousness, sense of observation, able to work under pressure and in a team;
  • Customer-oriented and flexible;
  • Knowledge of current pharmaceutical standards (GMP / GMP's, FDA and HPFB);
  • Knowledge of USP / EP / BP / JP pharmacopoeia;
  • Knowledge of regulatory requirements (FDA, Health Canada) related to records
Apply now!

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