- This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
- There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives.
- Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
- Leads new product introductions and lifecycle changes into Vial filling and Syringe filling from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.
- Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as and when required.
- Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, 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 NC/CAPA and technology transfer.
- Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
- Develops and characterizes drug product processes and transfers technology to commercial drug product sites.
- Identifies and implements operational opportunities for current and new sterile operations.
- Troubleshoots issues with drug product processing technologies and equipment.
- Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
- Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
- Development and execution of validation plans, process performance qualifications (PPQs) for vial and syringe filling with a cross functional team.
- 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).
- Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
- Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
- Contribute to product quality assessments and process flow documents.
- Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated product.
- Lead or assist in deviation and exception resolution and root cause analysis.
- Participate as required in project activities and be developing own project management techniques.
- Any other duties as assigned.
- A 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.
- PhD or Masters in Science or Engineering (preferred).
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills.
- 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, and/or lyophilization processes.
- Knowledge of protein biochemistry regarding 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 skill is essential for this role.
-
Tech Transfer Lead
1 week ago
PSC Biotech Ltd Dublin, IrelandJob Description · About PSC Biotech · Who 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 countrie ...
-
Tech Transfer Lead
1 week ago
PSC Biotech Ltd Dublin, Ireland· About PSC Biotech · Who 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 ...
-
Pharmacy Customer Business Manager
1 week ago
Haleon Dublin, Ireland Full timeHello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren ...
-
Performance Marketing Manager
5 days ago
Apiron Group IrelandÜBER APIRON · Wir sind eine in Deutschland tätige Digitalberatung mit den Schwerpunkten Marketing, Vertrieb & Datenanalyse. Die Apiron Group bietet modernste digitale Marketing- und Vertriebslösungen für Unternehmen, die sich der digitalen Komplexität stellen. · Dabei helfen wi ...
-
Security Technology Consultant
4 days ago
Zurich Insurance Company Ltd. Dublin, IrelandBackground · Established in 2013 and now based in Blackrock, the Dublin Technology Center delivers best in industry infrastructure and security services across the Zurich Insurance Group. Whether it's with one of our core capabilities such as Cyber Security, or working with our C ...
-
Senior Physiotherapist
5 days ago
Duffy Alexander Recruitment Dublin, IrelandSenior Physiotherapist - Hospital We are currently partnering with acute Hospitals across Ireland who have requirements for Senior Physiotherapists that has got experience working with in-patients in an acute Hospital setting. Role: Responsible for guiding and mentoring Staff lev ...
-
Commercial Finance Manager
5 days ago
Morgan McKinley Dublin, IrelandExciting opportunity for a Commercial Finance Manager to join a globally leading Biometric Company on a full-time basis in Dublin 1, with hybrid working available. The Commercial Finance Manager will report directly into the Senior Finance Manager and will not be a people managin ...
-
Solutions Specialist
5 days ago
Reperio Human Capital (Ireland) Ltd Dublin, IrelandSolution Specialist Dublin, Ireland Salary: €70,000+ Permanent, Full-time We are currently working with another one of our exciting clients, on the hunt for a Solution Specialist. The ideal candidate will have prior experience in an infrastructure, cloud and security environment ...
-
FP&A Accountant
5 days ago
Morgan McKinley Dublin, IrelandExciting 12 Month contract, remote opportunity for a FP&A Accountant to join our client, a leading pharmaceuticals company based in North Dublin. Morgan McKinley is delighted to partner with a leading multinational pharmaceutical company in search of an FP&A Accountant to join th ...
-
Social Performance Manager
3 days ago
Apiron Group IrelandÜBER APIRON · Wir sind eine in Deutschland tätige Digitalberatung mit den Schwerpunkten Marketing, Vertrieb & Datenanalyse. Die Apiron Group bietet modernste digitale Marketing- und Vertriebslösungen für Unternehmen, die sich der digitalen Komplexität stellen. · Dabei helfen wi ...
-
Operations Supervisor
3 days ago
Amazon Dublin, IrelandJob ID: | Amazon Transport Austria GmbH - H77 · Der operative Geschäftsbereich ist das Herz von Amazon. Ein effektiv ablaufender Betrieb trägt dazu bei, dass Artikel bearbeitet und rechtzeitig an unsere Kund:innen versendet werden. Als Operations Lead/Supervisor erlebst Du, wie a ...
-
Senior Specialist, Technical Services
1 week ago
Alexion Pharmaceuticals Dublin, Ireland Full timeThis is what you will do: · The Senior Specialist Technical Services has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at Alexion's facility in Blanchardstown, Dublin. The Senior Technical Specialist will provide processing exp ...
-
Process Engineer
3 days ago
Asset Recruitment Irelandref. 01158 · Process Engineer (Technical Transfer) · Our client, a leading multi-national Biotech company, is seeking enthusiastic candidates to join their External Manufacturing (ExM) Technical Operation team in two different sites, one located in Co. Louth – Ireland and one in ...
-
Embedded Software Engineer
4 days ago
Life Science Recruitment Ltd Dublin, IrelandTitle: Embedded Software Engineer Location: The Digital Hub, Rainsford St, Dublin 8. Benefits: Excellent salary, flexible working hours and Health insurance Role: My client are hiring an Embedded Software Engineer to work on a Next Generation Hardware platform for the lenire tinn ...
-
Customer Business Manager
3 days ago
Haleon Dublin, Ireland Full timeHello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren ...
-
Bristol Myers Squibb Dublin, Ireland Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Associate DP MSAT Engineer
1 week ago
Regeneron Pharmaceuticals, Inc Dublin, Ireland Full timeIn this role you will support equipment selection, CMO selection strategy, management of equipment qualification and process validation activities. You will be hands-on solving issues during technology transfer and cGMP start-up and take ownership for providing floor support duri ...
-
Pension Administrator
1 week ago
Elevate Partners Dublin, IrelandOur client a leading wealth management firm are currently looking for a Pension Administrator to join their team. The successful candidate will have excellent attention to detail and communication skills. · Key Responsibilities · Develop an in-depth understanding of the clients' ...
-
Scientist, Pharmaceutical MS&T Drug Product
1 week ago
Bristol Myers Squibb Dublin, Ireland Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Vice President, Client Processing Manager II
1 week ago
THE BANK OF NEW YORK MELLON CORPORATION Dublin, IrelandBring your ideas. Make history. · BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or ...
Tech Transfer Lead - Dublin, Ireland - TEAM HORIZON
Description
Team Horizon is seeking a Tech Transfer Lead (Intermediate) on an initial 12-month contract for our client who are a global leader in the biopharmaceutical industry. This is a hybrid position, based in their manufacturing site in Dublin. This role will require the candidate to provide process development support to new product introductions (NPI) and lifecycle changes to site, provide subject matter expertise for unit operations and support ongoing production. The candidate will provide technical support to large molecule and small molecule drug product manufacturing at the site as well as part of the global Process Development (PD) organization.Why you should apply:
What you will be doing:
What you need to apply: