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Tech Transfer Engineer
Employer undisclosedRole managed by a recruiter
Lead tech transfer activities for new drug substance manufacturing at a large-scale facility.
6d ago
Expert & Leadership (13+ years), Experienced (8-12 years)
Contractor
Dublin, County Dublin, Ireland
Onsite
Role
What you would be doing
troubleshooting
process investigation
stakeholder engagement
document authoring
tech transfer
plant studies
- To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
- Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.
- Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
- Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for a new product introduction to the MPCC Cruiserath.
- To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale
What you bring
cgmp
technical writing
interpersonal
bsc
tech transfer
drug manufacturing
- You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
- Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organisation, and in local group settings.
- Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles:
- Minimum BSc or equivalent with extensive experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities.
- Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
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