Junior Tech Transfer Lead - NPI & Process Development

DPS Group Global

Dublin

On-site

EUR 65,000 - 95,000

Full time

11 days ago

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Job summary

DPS Group Global in Ireland is seeking a Process Development Specialist to support NPI and lifecycle management changes for biologics drug product manufacturing within the global Process Development organization. The role includes moving to a new building with single-use end-to-end processes and syringe fillers.

You will lead product transfers from concept to PPQ, support validation activities, and ensure compliance with global regulatory requirements.

Qualifications

Bachelor’s degree in science, engineering or equivalent with 2 years in commercial manufacturing or NPI, or Master’s degree with 1 year related experience, or Associate’s with 5 years.
Strong technical writing skills.
Knowledge of cGMPs and worldwide regulatory requirements.
Excellent problem solving and communication skills.

Responsibilities

Support and lead NPI from concept to PPQ and product filings.
Own product transfer projects from initiation to regulatory approval.
Provide solutions for trouble-shooting drug substance processing and parenteral filling.
Develop process design and validation documentation for syringe filling and characterization.
Collaborate across sites to ensure transfer and validation rules are followed.
Participate in 24/7 support for projects as needed.