Product Development Associate

3 weeks ago

Montréal QC, Canada Groupe PARIMA Inc Full time

Groupe PARIMA is aContract Development and Manufacturing Organization (CDMO), established in 1994. For over 25 years, we have developed an expertise in the development and manufacturing of non-sterile liquids, suspensions and semi-solid drug products.

Product Development Associate

The product development associate provides hands-on support to product development activities associated with product development projects and commercial products.

Responsibilities:

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

Skills and experience required:

  • DEC or Bachelor’s degree in Science (Chemistry, or related technical/scientific field), from a Canadian University, or an equivalent scientific diploma recognized by a Canadian University or an accredited Canadian organism.
  • Minimum of three (3) year of experience in a cGMP pharmaceutical environment.
  • Some practical experience in semi-solid dosage forms and/or process development and/or cleaning assessment,
  • Experience in formulation (Asset)
  • Dynamic and multitasking ability
  • 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.

What we offer:

  • Recognition program & social activities
  • Personal days
  • Employee assistance program & online medical service
  • Accessible by public transit or free parking
  • Referral program

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