Tech Transfer

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 currently recruiting for a Tech Transfer Lead (Junior) for a leading multi-national Pharma client based in South Dublin.

This is a contract position.

This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes at ADL. In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing at ADL as part of the global Process Development organization. With the intention of moving to a new building construction that will house single use end to end processes and new syringe fillers.

The successful candidate will need to be prepared to participate in 24/7 support once or twice a quarter (depending on business needs) for approx. 1-2 weeks at a time.

Confirmed shift pattern: Its 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off.

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 the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval.
• Provide solutions when trouble shooting drug substance freeze/thawing, formulation, filling syringes, inspection and transportation for parenteral products through the NPI or post-NPI phases.
• Provide process development knowledge for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and process validation, input on design for new parts of the facility where needed. Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.
• Development of documentation and process design for characterisation studies, engineering runs, electronic batch record creation, validation plans, process performance qualifications for syringe filling.
• Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
• Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.

Requirements:

• 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 (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
• Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity). Knowledge of protein biochemistry with regard to chemical and physical stability.
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements
• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role.

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland