Your new company

This role will support development projects and manufacturing operations and be responsible for leading or supporting Process Development, Technical Transfer, Process Validation, Manufacturing investigations, Life Cycle Management and Health Authority Inspections.

Your new role

• Supporting early and late phase Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.
• Supporting early and late phase product development activities through generation of protocols/reports, execution of laboratory scale studies and participation in Lean Early Development initiatives as required.
• Supporting “process fit to plant” during early and late stages of development to provide guidance to both development and manufacturing teams.
• Supporting “man in plant” by providing support during manufacturing campaigns for new products or during process validation campaigns.
• Providing expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations.
• Partnering with Project Teams to provide input, review and approval support for BLA submissions.
• Participating in cross-functional project teams.

What you'll need to succeed

• A minimum of a Bachelor's degree in Biology, Pharmacy or related scientific field is required; an advanced degree is preferred.
• 2+ years’ experience within a regulated biologics or pharma industry
• Biological process development or commercial manufacturing experience, either cell culture and/or purification.
• Excellent communication skills, both oral and written.
• Capable of planning and executing experiments or steps with some supervision.
• Ability to work well in a team environment, strong collaboration skills and flexibility.
• Excellent interpersonal skills with the ability to adapt to rapid changes in project priorities and requirements.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

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