Senior Technical Scientist
Job ID: JOB-12160
Senior Technical Scientist
Our multi-national pharmaceutical client are seeking a Senior Technical Scientist to join their team on site in Cork on a contract basis.
As a Technical Scientist your typical day may include:
- 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.
- Interpreting project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
- Assisting in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
- Executing experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
- Fostering a culture of Lean and Continuous improvement within the department and with internal and external partners.
- A minimum of a Bachelor’s degree in Biology, Pharmacy or related scientific field is required, 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 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.
- Acute attention to detail
For further information on this role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
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