Product Development Associate

The Product Development Associate provides hands-on support to packaging, validation and formulation specialists in accomplishment of product development projects.

Responsibilities:

  • Provide on-the-floor oversight of the manufacturing and packaging processes, as necessary
  • Participate in the drafting of forms, procedures, manufacturing and packaging batch records, protocols and reports necessary for the proper functioning of the PDS department
  • Participate in the technical assessment of new projects, working in close collaboration with internal and external collaborators
  • Participate in problem solving and investigations for PDS batches and cleaning activities
  • Participate in the creations, execution and closure of change controls and CAPA
  • Perform swabbing for the equipment cleaning assessment and cleaning validation
  • Write protocols and reports
  • Coordinate the analytical works with chemistry and microbiological laboratories
  • Manufacture lab-scale batches
  • Document activities and data in a timely manner, ensuring pertinent information can be retrieved within a reasonable period of time
  • Ensure that all lab-scale batches work is performed in compliance with GMP, SOP, and regulatory standards
  • Operate, maintain and control de conformity of laboratory equipment
  • Provide support to project manager with documentations, assistance with weekly planning and occasional follow up with clients
  • Coordinate and support the inventory (raw material, API and packaging components) of product development batches

Skills and experience required:

  • DEC or Bachelor’s degree in Science (Chemistry, or related technical/scientific field), from an accredited Canadian organism
  • Minimum of one (1) year of experience in a cGMP pharmaceutical environment
  • Some practical experience in semi-solid dosage forms and/or process development and/or cleaning assessment
  • Good working knowledge of GMP, GLP, Safety and FDA guidelines
  • Very organized and detail oriented, with a strong focus on accurateness
  • Good interpersonal and communication skills (both in English and French; written and spoken)
  • Strong problem solving, technical writing
  • Proficient in Process Safety concepts and methodology
  • Able to lead and assist in training others
  • Able to be flexible and adapting to process schedules

Application for the position of  Product Development Associate

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