* Supports early and late phase Technical Transfer activities through generation and execution of protocols/reports, technical writing, participation in manufacturing operations and NPI initiatives.
* Supports "process fit to plant" to provide guidance to both development and manufacturing teams.
* Leads "man in plant" by providing support during manufacturing campaigns for new products or during process validation campaigns.
* Provides expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations.
* Partner with Project Teams to provide input, review and approval support for BLA submissions
* Participate in cross-functional project teams.
* Assist in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
* Execute experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
* Foster a culture of Lean and Continuous improvement within the department and with internal and external partners
* A minimum of a Bachelor's degree in Engineering, Biology, Pharmacy or related engineering/scientific field is required, advanced degree is preferred.
* Minimum 3 years experience in pharmaceutical or biotechnology 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 projects 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.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists