Biotech Tech Transfer Lead
2 weeks ago
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.
-
Biotech Tech Transfer Lead
2 weeks ago
County Dublin, Ireland Jobcontax Full timeBiotech 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...
-
Biotech Tech Transfer Specialist
1 week ago
Dublin, Dublin City, Ireland TN Ireland Full timeJob DescriptionWe are seeking a highly skilled Biotech Tech Transfer Lead to join our team at TN Ireland. This is an excellent opportunity for a process development expert to lead new product introductions (NPI) and lifecycle management changes in our state-of-the-art aseptic manufacturing facility.The successful candidate will be responsible for providing...
-
Tech Transfer Specialist
4 weeks ago
Dublin, Dublin City, Ireland LSC, Life Science Consultants Full timeTech Transfer Specialist (BBBH28228) Meath, Republic of IrelandLSC have a great contract opportunity for a Scientific Technical Specialist to join a leading biotech company based in Meath.ABOUT THE PROJECT - KEY RESPONSIBILITIES:Collaborate with stakeholders to execute the transfer requirements of both late stage clinical and/or PPQ (Process Performance...
-
Technology Transfer Specialist
3 weeks ago
Dublin, Dublin City, Ireland PSC Biotech Full timeIndustry Pharma/Biotech/Clinical ResearchWork Experience 4-5 yearsCity MeathState/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, Singapore, Australia and the US, serving 350 clients in...
-
Technology Transfer Specialist
2 weeks ago
Dublin, Dublin City, Ireland PSC Biotech Full timeIndustry Pharma/Biotech/Clinical ResearchWork Experience 4-5 yearsCity MeathState/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, Singapore, Australia and the US, serving 350 clients in...
-
Biotech Tech Transfer Lead
3 weeks ago
Dublin, Dublin City, Ireland TN Ireland Full timeSocial network you want to login/join with:Employment Type: ContractWork Location: Site Based / HybridExperience: 5+ yearsVisa: EU passport or Stamp 4 visa requiredOur 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...
-
Biotech Technical Specialist
2 weeks ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeAbout the RoleWe are seeking a highly skilled Biotech Technical Specialist to join our team at PSC Biotech Corporation. As a key member of our technical staff, you will play a critical role in the development and implementation of technical solutions for our clients.Key ResponsibilitiesLead activities to deliver on Tech Transfer requirements needed to...
-
Tech Transfer Professional
1 week ago
Dublin, Dublin City, Ireland Recruitment by Aphex Full timeJob DescriptionThis is a highly specialized role that requires collaboration with stakeholders to execute the transfer requirements of both late stage clinical and/or PPQ programs.ResponsibilitiesCollaborate with stakeholders to ensure seamless NPI delivery across internal partners such as Process Engineering, Quality, Operations, Process Automation and...
-
Biotech Transfer Expert
1 week ago
County Dublin, Ireland Jobcontax Full timeJob Overview">The Biotech Tech Transfer Lead position at Jobcontax offers a unique opportunity to join our team and contribute to the success of our international Biotechnology company. Our state-of-the-art aseptic manufacturing facility in South Dublin is undergoing rapid expansion and capital investment, making this an exciting time to be part of our...
-
Senior Tech Transfer Specialist
3 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeExciting Opportunity with a Biopharmaceutical OrganizationWe're currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dunboyne. 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- Collaborate with stakeholders to identify and execute...
-
Senior Tech Transfer Specialist
2 days ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeExciting Opportunity with a Biopharmaceutical OrganizationWe're currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dunboyne. 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.DutiesCollaborate with stakeholders to identify and execute...
-
Biotech Process Scientist
5 days ago
Dublin, Dublin City, Ireland CPL Full timeCPL, in partnership with Pfizer, is seeking a highly skilled Biotech Process Scientist to join their team for an 11-month fixed-term contract at their state-of-the-art Dublin Grange Castle site. This hybrid working role offers an ideal development opportunity to join a dynamic team that provides process science support and new product tech transfer into...
-
Tech Transfer Engineer
2 weeks ago
Dublin, Dublin City, Ireland Headcount Solutions Full timeHeadcount Solutions is seeking a Tech Transfer Engineer for our multinational client's biotech facility in Dublin. This person will join a Manufacturing Technology group responsible for process validation and continued technical support to cell culture and primary recovery unit operations for the commercial manufacture of multiple mammalian cell processes in...
-
Biotech Process Development Lead
1 week ago
Dublin, Dublin City, Ireland Recruitment by Aphex Full timeJob OverviewWe are seeking a skilled Tech Transfer Specialist to support the delivery of seamless New Product Introduction (NPI) across our multi-product facility.Main ResponsibilitiesCollaborate with stakeholders to ensure the successful transfer of new products into our facility.Develop and deliver GMP documents related to Tech Transfer.Manage new program...
-
Biotech Process Engineering Specialist
1 week ago
Dublin, Dublin City, Ireland PSC Biotech Full timeAbout 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. We serve 350 clients across more than 23 countries worldwide.We provide cloud-based software solutions for quality management and regulatory inspections,...
-
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeAbout PSC Biotech CorporationPSC Biotech Corporation is a leading biotech consultancy firm with operations in the US, Ireland, India, Singapore, Australia, and globally, serving over 350 clients across more than 23 countries. We specialize in providing cloud-based software solutions for quality management, regulatory inspections, pharmaceutical contract...
-
Dublin, Dublin City, Ireland LSC, Life Science Consultants Full timePharmaceutical Validation and Tech Transfer LeadAbout the Role:We are seeking a highly experienced Pharmaceutical Validation and Tech Transfer Lead to join our team at LSC, Life Science Consultants. As a key member of our Technical Services department, you will be responsible for leading the development and implementation of validation and tech transfer...
-
Biotech Operations Specialist
2 days ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timePSC Biotech Corporation OverviewWe are a leading consultancy firm providing cloud-based software solutions for Quality Management and Regulatory Inspections. Our mission is to provide innovative solutions that help our clients succeed.Job SummaryThis Technical Engineering role will play a key part in the development of client site drug product facility.This...
-
Biotech Process Specialist
1 week ago
Dublin, Dublin City, Ireland LSC, Life Science Consultants Full timeWe are seeking a Biotech Process Specialist to join our team at LSC, Life Science Consultants.Tech Transfer Specialist (BBBH28228)LSC have an excellent opportunity for a Scientific Technical Specialist to collaborate with stakeholders and execute the transfer requirements of late stage clinical and/or PPQ programs.Key Responsibilities:Collaborate with...
-
Tech Transfer Engineer
2 weeks ago
Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full timeTech Transfer Engineer - Dublin, Ireland - TBCOne of the top 10 best companies to work in Ireland is looking for a Tech Transfer Engineer for their large-scale new facility in Dublin. Is this you?An exciting project with lots of opportunities to learn new technology and develop current skills within a fast-paced €1 billion project. This fantastic client...
