Are you ready to be at the forefront of biotechnology excellence?
This is a rare opportunity to join one of the world's leading independent biotechnology companies in South Dublin as an Aseptic Process Owner, where you will play a pivotal role in a high-impact project shaping the future of pharmaceutical manufacturing in Ireland.
If you have 5 years of experience working in the sterile pharmaceutical or biotechnology industry and are ready for your next challenge, if this sounds like your next move, we'd love to hear from you.
Contract | Dublin | Duration: 12 months
ABOUT THE PROJECT
This role in the organisation requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.
The Aseptic Process Owner will continue to build on the site and network aseptic processing knowledge and represent the Dublin site at a global level across the Amgen manufacturing network.
As the Aseptic Process Owner you will be an established professional who is a self-starter, capable of applying advanced process knowledge and creativity to complete complex assignments related to aseptic operations. You are someone who contributes to the development of new principles and concepts, who wants to be challenged and can lead change from an aseptic operations perspective.
KEY RESPONSIBILITIES:
- Perform as a knowledgeable subject matter expert (SME), and point of contact on site and network projects and programs, to advance aseptic operations
- Leading and/or providing input to strategic initiatives that will improve and develop Manufacturing processes for the future including Contamination Control and Aseptic Process Simulations (APS)
- Contribute to a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required
- Remain current on state-of-the-art systems and processes and advise on the appropriate adoption and use of new techniques and technology.
- Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends (Personnel and Environmental Monitoring), including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future
- Lead and/or support investigations/ risk-based decisions that impact on safety, quality and/or compliance of the processes, ensuring thorough investigations are carried out and actionable CAPAs, to prevent future reoccurrence, are identified and implemented within agreed timelines
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree in Microbiology or related discipline with 5 + years' experience in the sterile pharmaceutical industry
- Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products and its interpretation.
- Proven ability to work in a high paced matrix organization and effectively influence change and escalate issues professionally and in a timely manner
- Excellent Decision-Making skills and confidence to respectfully and professionally challenge others on decisions that impact the manufacturing area
WHY LSC?
LSC work exclusively in the Life Sciences sector. Founded and run by contractors, we understand contracting first-hand and have created a unique approach to make the process as smooth as possible, so you can focus on delivering your best work. With over 23 years' experience supporting the industry, we bring deep sector knowledge and long-standing client relationships.
At LSC, we partner with you for the long term, not just the duration of your contract. We are committed to building lasting relationships and will work closely with you to ensure you are placed on projects that challenge, develop, and reward you throughout your career.
What You Can Expect.
- Work on-site with leading biopharma organisations on high-impact projects
- Structured onboarding to ensure you're set up from day one
- Ongoing support and regular engagement from LSC throughout your assignment
- Be part of a wider LSC consultant network
- A dedicated team behind you; you're not navigating projects or contracts alone
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G or Stamp 4 visa to apply.
Apply via this advert or contact Kathy Gillen on 021 4777329 if you have any questions about this role.
Find out more about working with LSC at lscconnect.com
