Job Description

The Manufacturing Sciences Manager’s role is to guide process development and analytical development strategies using a risk-based approach and develop product manufacturing control strategies. The manager will exert a leadership role in organizing the quality by design (QbD) platform necessary for the preparation of process qualification and during commercial stage, continuous process verification.

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The manager will also provide support during process and analytical technological transfer and changes, as well as during process scale-up at the manufacturing sites.

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Based on process and analytical validation guidance and regulatory requirements, the incumbent will prepare and/or review the related regulatory filings section.

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Other responsibilities include usage of best scientific/industrial practices in the development and/or use of new processes to ensure scalable process are transferred to CMO, oversight of GMP manufacturing activities, as well as outsourcing to contract development laboratories.

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Finally, this position will have administrative responsibilities of developing the necessary resources required to perform delegated assignments.

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This is a full-time position reporting to the Vice-President of Manufacturing.

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Responsibilities:

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• Develop and manage a manufacturing science platform for process and analytics for biological products using a quality by design approach.
• Ensure that a risk assessment is performed to support the decision-making process.
• Directly participate to technology transfer and process scale up to recipient contractors’ facilities.
• Develop process qualification strategy and lead execution.
• Lead and execute the preparation of comparability protocols.
• Ensure timely continuous process verification.
• Participate to regulatory filings.
• Ensure adequate work distribution and execution within defined timelines, whether internally or using outsourced resources.
• Develop a team of professionals and scientists participating in manufacturing sciences using Quality by Design and validation activities according to cGMP.
• Act as a subject matter expert and use scientific knowledge and industry best practices in use for process validation.
• When required, provide oversight during manufacturing activities.

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Qualifications:

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• Master’s (M.Sc.) degree in pure or applied sciences or equivalent
• At least 10 years of experience in the biopharmaceutical industry, especially in development and validation of biologics manufacturing processes
• At least 5 years of experience of team and project management
• Experienced in Risk Assessment (i.e.: FMEA)
• Advanced experience in upstream, or downstream processing, and fill/finish for biologicals in a GMP manufacturing environment
• Strong experience and knowledge of the Good Manufacturing Practices (GMP) in a regulated environment (pharmaceutical)
• Solid experience in process validation (as per FDA 2011 guidance)
• Experienced with technology transfer and scale up
• Capable of planning, organizing, and prioritizing work in a fast-paced environment
• Experience using statistical tools
• Experience in problem solving and negotiations skills will be an asset.

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Contact:

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Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma Posting MSM0930” in the subject line – we are looking forward to hearing from you!