- Location
- Dublin, D,IE, IE
- Type
- Full-time
- Department
- IT
- Experience
- 3+ years
- Education
- Master
- Source
- Eightfold
Description
Introduction to role:
Are you ready to turn downstream expertise into reliable, cGMP-grade supply that changes the lives of people with rare and devastating conditions? In this role, you will be the downstream technical authority enabling biological bulk drug substance manufacture at our Dublin (Blanchardstown) site.
You will connect science to performance across technology transfer, process validation and commercial operations—getting new products started up, qualified and sustained at speed. Partnering across Process Development, Operations, Engineering, Quality, Supply Chain and Regulatory, you will transform complex requirements into robust, right-first-time manufacturing. Can you see yourself guiding CPV strategy, resolving deviations fast and delivering yield and cycle-time gains that matter to patients and the business?
Accountabilities:
\- Downstream Process Ownership: Provide subject-matter expertise across buffer preparation, chromatography, ultrafiltration/diafiltration, viral reduction and inactivation, drug substance formulation and bulk fill to ensure consistent, compliant performance.
\- Technology Transfer and Validation: Lead and support new product introduction, process performance qualification (PPQ), and facility/process start-up activities; plan and execute risk assessments using QRM tools to secure right-first-time outcomes.
\- Continuous Process Verification: Lead or support the site CPV program, define control strategies, and translate data into actions that sustain process capability and product quality.
\- Materials Integration: Introduce and maintain raw materials and consumables by generating materials lists, bills of materials, specifications and testing requirements; manage changes to protect continuity of supply.
\- Documentation and Knowledge Management: Author and review process technical documentation, gap assessments, technical protocols and reports, validation documentation and strategy documents; contribute to Common Technical Document (CTD) sections for regulatory submissions.
\- On-the-Floor Technical Support: Provide real-time troubleshooting during manufacturing; lead investigations into process deviations to root cause and durable corrective actions; design and execute plant studies at commercial scale.
\- Change Control and Compliance: Lead key process changes via the change control system; uphold EHS and cGMP standards; implement corporate standards; prepare for and support internal and external audits and health authority inspections.
\- Cross-Functional Influence: Work seamlessly with Process Development, sending unit, Operations, Engineering, Supply Chain, Quality and QC to meet transfer and routine manufacturing timelines and elevate operational excellence.
\- Operational Flexibility: Provide periodic out-of-hours and on-call support during engineering and validation batches to maintain schedule adherence and technical oversight.
Essential Skills/Experience:
\- B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
\- Minimum 3+ years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
\- Technical and operational knowledge of multiple unit operations in cell culture processing.
\- Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
\- Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
\- Ability to present and defend technical and scientific approaches in both written and verbal form.
\- Ability to drive for results independently and adapt to rapidly changing priorities.
\- Detail orientated.
\- Technical writing competency.
Desirable Skills/Experience:
\- M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
\- Experience of Technology Transfer activities.
\- Knowledge or experience of start-up or systems.
\- Experience of authoring CMC sections of regulatory submissions.
Why AstraZeneca:
Here you will shape medicines for people with the greatest unmet need while growing your own capabilities at pace. We combine the energy and autonomy of a leading biotech environment with the resources and stability of a global biopharma. Expect cutting-edge science and manufacturing technology, unexpected teams in the same room unleashing bold thinking, and leaders who back ambition with tailored development. We bring kindness alongside high standards—listening deeply to patient experience, empowering you to take ownership across boundaries, and supporting you to stretch beyond your lane to make a measurable difference from our Dublin site to patients worldwide.
Call to Action:
Step into a role where your downstream mastery speeds life-changing biologics to patients—submit your application today!
Date Posted
22-Jul-2026
Closing Date
04-Aug-2026
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
