Biotech Tech Transfer Lead

2 weeks ago


Dublin, Dublin City, Ireland JobContax Full time

Biotech Tech Transfer Lead - Dun Laoghaire, Dublin

Office/Project Location: Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:  Site Based / Hybrid

Pay: €50 - €60 per hour

Experience:  5+ years

Visa:  EU passport or Stamp 4 visa required

Biotech Tech Transfer Lead - Dun Laoghaire, Dublin

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes. 

You will establish themselves in a product lead role where the majority of input provided will be leading of process performance qualification (PPQ). 

In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing as part of the global Process Development organization. 

Leads new product introductions from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.

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 freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases.

Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. 

Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.

The position will report to Process Development Senior Engineer. 

Moderate international travel might be required during the course of the project.

Development of validation plans, process performance qualifications for vial and 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.

Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.

Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.

Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.

Act as the responsible point contact from ADL site for the transfer project for drug product teams and Global Operations Teams.

Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.

Collate and report on relevant shipping and filter validation.

Assist in deviation and exception resolution and root cause analysis.

Contribute to product quality assessments and process flow documents.

Requirements

Third level Bachelor's degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.

Knowledge of cGMPs and other worldwide regulatory requirements.

Problem solving ability and excellent oral and written communications skills.

Product validation experience (not equipment validation).

Manufacturing experience.

Syringe / Vial filling / Process Validation / Performance Qualification / PPQ Process Characterisation.

Biologic or protein manufacturing / if they have powder or tablet.

Please note: think people getting equipment and process mixed up with submissions based on past submissions. 

Not equipment which is product / process validation PE. 

Need to know how the product works and how it works.

Preferred Qualifications

Doctorate or Masters in Science or Engineering.

5 + years of 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) and/or lyophilisation processes. 

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.

Package

Contract role - Hourly rate €50 - €60 per hour

Minimum 12 month contract with the possibility of an extension. 

Onsite Requirements:

Core hours: 08:30 to 17:00.

Prepared to be onsite more regularly at the start to integrate into the team.

Requirement long-term to be onsite 3 days per week & come onsite when needed.

Shift Patterns:

Once every quarter there is a need to support shift works is based on the support of PPQs and engineering runs. 

As the business has changed, we will do more regular shift work and will require the support from the team. 

Shifts are 2 days on and 2 nights on and 4 days off and repeats like that. 

07:00 and 07:00 pm and 07:00 am to 07:00 pm @ 35% shift rate.


  • Tech Transfer Lead

    2 weeks ago


    Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

    Industry Pharma/Biotech/Clinical Research Work Experience 5+ years City Dublin State/Province Dublin Country Ireland Job DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350...


  • Dublin, Dublin City, Ireland PSC Biotech Full time

    - Industry: Pharma/Biotech/Clinical Research- Work Experience: 5+ years- City: Dublin- State/Province: Dublin- Country: IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350...


  • Dublin, Dublin City, Ireland PSC Biotech Full time

    Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Meath State/Province Meath Country Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving...


  • Dublin, Dublin City, Ireland PSC Biotech Full time

    Dunboyne, Ireland | Posted on 11/26/2024Industry: Pharma/Biotech/Clinical ResearchWork Experience: 4-5 yearsCity: DunboyneState/Province: MeathCountry: IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore,...


  • Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

    Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Meath State/Province Meath Country Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving...


  • Dublin, Dublin City, Ireland PSC Biotech Full time

    Technical Operations - Manufacturing Drug Specialist Industry: Pharma/Biotech/Clinical Research Work Experience: 5+ years City: Louth State/Province: Louth Country: Ireland Job DescriptionAbout PSC Biotech:PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India,...


  • Dublin, Dublin City, Ireland LSC, Life Science Consultants Full time

    Validation and Tech Transfer Specialist (BBBH27990) Dublin, Republic of IrelandThe Validation & Tech Transfer Specialist will be responsible for developing and maintaining validation (process and cleaning validation, continued process verification) and tech transfer guidance and supporting toolkit to support implementation in a consistent manner across...


  • Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

    Technical Operations - Manufacturing Drug SpecialistIndustry: Pharma/Biotech/Clinical ResearchWork Experience: 5+ yearsCity: LouthState/Province: LouthCountry: IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore,...


  • Dublin, Dublin City, Ireland CPI Biotech Full time

    As we continue to grow our SUT portfolio, an exciting opportunity exists to join CPi Biotech as a Lead Product Manager – Single Use Technologies.We're looking for someone with 4 plus years' experience in a Project Management / Engineering related role.Duties and ResponsibilitiesDrive the product- and business-planning processes for cross-functional...

  • Lead Tech, Operations

    2 weeks ago


    Dublin, Dublin City, Ireland Merck Gruppe - MSD Sharp & Dohme Full time

    Job DescriptionAn amazing opportunity has arisen for aLead Bioprocess Associate in our new state of Manufacture of Commercial Large-Scale Drug Substance Biotech facility.The successful candidate will be a leader with strong interpersonal, communication and collaboration skills responsible for supporting the manufacturing process, whilst creating an inclusive...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Exciting Opportunity with a Leading Biopharmaceutical OrganizationWe're currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties1. Development of validation plans,...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Exciting Opportunity with a Leading Biopharmaceutical OrganizationWe're currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.DutiesDevelopment of validation plans,...

  • Change Control Lead

    3 days ago


    Dublin, Dublin City, Ireland PSC Biotech Full time

    Tipperary, Ireland | Posted on 02/18/2025Industry: Pharma/Biotech/Clinical ResearchWork Experience: 4-5 yearsCountry: IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350...

  • Tech Lead

    2 weeks ago


    Dublin, Dublin City, Ireland realTime Recruitment Full time

    Job Opening Tech Lead Permanent Dublin 14-06-2023 TECH LEAD ROLEOne of my clients is a company that helps large organizations sustain or extend their advantage through new innovations. They are looking for a Tech Lead with a view to progressing to a manager role in the future.Start-up environment working on a Fintech Application and the ideal...


  • Dublin, Dublin City, Ireland PSC Biotech Full time

    Job DescriptionAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...


  • Dublin, Dublin City, Ireland JobContax Full time

    Biotech Manufacturing Investigation Lead Specialist - Dun Laoghaire, Dublin Office/Project Location: Dun Laoghaire, Dublin Employment Type: Contract Work Location:  Site Based / Hybrid Pay: €50 - €60 per hour Experience:  7+ years Visa:  EU passport or Stamp 4 visa required Biotech Manufacturing Investigation Lead Specialist -...


  • Dublin, Dublin City, Ireland PSC Biotech Full time

    Dunboyne, Ireland | Posted on 12/06/2024Industry: Pharma/Biotech/Clinical ResearchWork Experience: 1-3 yearsCity: DunboyneState/Province: MeathCountry: IrelandJob DescriptionAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India,...

  • Product Lead

    2 weeks ago


    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Exciting Opportunity: Product Lead – Process DevelopmentWe're currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties:The Product Lead – Process Development...

  • Product Lead

    2 weeks ago


    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Exciting Opportunity: Product Lead – Process DevelopmentWe're currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties:1. The Product Lead – Process...

  • Material Handler

    2 weeks ago


    Dublin, Dublin City, Ireland PSC Biotech Full time

    Job DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...