specialists in process development and technology transfer (Int.)

DESCRIPTION DU POSTE

FOP CONSULTANTS is looking for specialists in process development and technology transfer at the intermediate level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to develop and optimize processes using QbD and DoE principles, to plan and coordinate technology transfer and scale-up and to document process knowledge and ensure successful batches in collaboration with production, quality and regulatory affairs.

KEY RESPONSIBILITIES

• Develop and optimize manufacturing processes at laboratory and pilot scale.
• Apply quality by design (QbD) principles and design of experiments (DoE).
• Plan and coordinate technology transfer between sites or to a contract manufacturer.
• Carry out scale-up and engineering, trial and demonstration batches.
• Draft development reports, transfer packages and manufacturing documents.
• Assess risks and resolve technical process issues.
• Collaborate with R&D, production, validation, quality and regulatory affairs

CANDIDATE PROFILE

• Bachelor's or master's degree in engineering (chemical engineering), sciences (chemistry, pharmaceuticals), or any other related discipline.
• Five (05) to ten (10) years of industry experience.
• Three (03) to seven (07) years of experience as a Specialist in Process Development and Technology Transfer.
• Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
• Tools and systems: MS Office suite, AutoCAD, Aspen Plus, SAP, MS Project.
• Hold one of the following certifications: Six Sigma Green Belt.
• The following are considered assets: membership in the Ordre des ingénieurs du Québec (OIQ), PMP, Six Sigma Black Belt, Lean Manufacturing.
• Experience in Canadian public or private organizations.
• Language: French and English