Tech Transfer Engineer
Employer undisclosedRole managed by a recruiter
Support tech transfer and validation of drug substance manufacturing processes.
6 days ago ago
Expert & Leadership (13+ years), Experienced (8-12 years)
Contractor
Dublin, County Dublin, Ireland
Onsite
Role
What you would be doing
process troubleshooting
manufacturing investigation
protocol development
plant studies
stakeholder partnership
technical writing
- To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
- To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale
- 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.
What you bring
bsc
tech transfer
cgmp
drug manufacturing
interpersonal
scientific writing
- 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.
- Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organisation, and in local group settings.
- Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
- You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
- Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles:
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
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Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
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