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Technical Scientist - Cell Culture

Quality & Laboratory
Siobhán Lane
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Job Reference: JO-2010-65416_1602234477



* 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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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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