Scientist, Process Development

Description du poste

The Process Development Scientist’s role is to lead new complex protein production industrialization efforts developing upstream processes that are transferable to a CDMOs contracted to produce clinical trial material. The incumbent will develop and optimize upstream processes for biotherapeutics molecules manufacturing, expressed in mammalian CHO cell lines. The role will require an active contribution setting up and operating the mammalian CHO cell production platform of the company.

The Process Development Scientist will also be involved in technology transfer and scale-up to CDMOs, as well as the oversight during GMP batch manufacturing campaigns. Other responsibilities are to use best scientific / industrial / regulatory practices in all given projects and integrate the process development effort with the analytical team.

This is a full-time maternity leave replacement position for 15 months that reports to the Director of Process Development and is based in Montreal, QC, Canada.

Duties and Responsibilities :

• Participate in manufacturability assessments for new protein candidates
• Organize the preparation of stable pool to express 35Pharma recombinant proteins
• Perform transfection, stable pools and transitory cell culture for production of recombinant proteins
• Perform early-stage upstream process development / optimization in shake flasks and Bioreactor (e.g. : Wave Bioreactor)
• Design, develop and optimize upstream manufacturing processes, including CHO cell line development, using a quality by design (QbD) approach
• Plan and design experiments and write study protocols
• Responsible for executing protocols, data analysis and report writing
• Responsible for maintenance and operation of cell culture laboratory equipment
• Coordinate sample testing with the Analytical team
• Participate in the technology transfer and scale-up to contract manufacturing organizations
• Participate in process improvements projects (e.g. process robustness, control and cost of goods (COGs)).
• Review manufacturing documentation as required and assist in the writing of regulatory submissions
• Provide technical / scientific support during GMP manufacturing campaigns, including investigations of non-conformities

Qualifications :

• Master of Science (M.Sc.) in biochemistry, biotechnology or equivalent with 3 years of relevant experience.
• Practical Experience with either upstream processes (mammalian cell culture), or the preparation of industrial grade cellular clones.
• Experience with industrial downstream process development is an asset
• Experience with scale-down model, design of experiments (DOE) and statistical software is an asset
• Knowledge of Good Manufacturing Practices in a regulated environment
• Knowledge of industrial expression systems, upstream and downstream processes technologies
• Ability to work in cross-functional teams and in a fast-paced environment
• Experienced in problem solving and troubleshooting
• Excellent verbal and written communication skills

35Pharma is an equal opportunities employer and welcomes applications from all qualified candidates.

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