Tech Transfer Lead (Junior) — Pharma Process Development

PE Global; Dún Laoghaire-Rathdown; On-site; EUR 60,000 - 75,000; Full time

Job summary

PE Global is recruiting a Tech Transfer Lead (Junior) for a leading pharma client in South Dublin. This contract role focuses on process development for NPI and lifecycle changes, and provides technical support to biologics drug product manufacturing within the global PD organization.

The role includes occasional 24/7 coverage for business needs, with a shift pattern of 2 days 7am–7pm, 2 nights 7pm–7am, 4 days off. Visa sponsorship is not available for this position.

Qualifications

• Third level Bachelor’s degree in science, engineering or equivalent discipline with 2 years experience in a commercial manufacturing or NPI role OR Master’s degree & 1 years of directly related experience OR Associate’s degree & 5 years of directly related experience.
• Strong technical writing skills.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills.
• Experience in support of Commercial Protein Drug Product processing in sterile processing, process characterization, tech transfer or validation.
• Strong engineering and scientific principles applied to process validation of protein freezing, filtration, mixing, filling.

Responsibilities

• Support and/lead new product introductions to ADL PM3 from concept to PPQ from a Process Development perspective and complete product filings.
• Be accountable for success of the product transfer project from initiation to transfer, including line characterisation and PPQ.
• Provide solutions for drug substance freeze/thawing, formulation, syringe filling, inspection and transport for parenteral products during NPI or post-NPI phases.
• Provide process development knowledge for commercial drug product processing including sterile processing, process characterization, tech transfer and validation.
• Develop documentation and process design for characterization studies, engineering runs, eBR creation, validation plans, and process performance qualifications.
• Ensure adherence to policies and safety training across all activity, and meet regulatory quality requirements (FDA, EU, international).
• Support Change Control/NC/CAPA and technology transfer for commercial drug product manufacturing operations.

Skills

Process development

NPI

Tech transfer

cGMP

Project management

Technical writing

Cross-functional leadership

Education

Bachelor's degree in science/engineering

Master's degree (related field)

Tools

Electronic batch records

QA documentation systems

Job description

PE Global is recruiting a Tech Transfer Lead (Junior) for a leading pharma client in South Dublin. This contract role focuses on process development for NPI and lifecycle changes, and provides technical support to biologics drug product manufacturing within the global PD organization.

The role includes occasional 24/7 coverage for business needs, with a shift pattern of 2 days 7am–7pm, 2 nights 7pm–7am, 4 days off. Visa sponsorship is not available for this position.