Are you ready to apply your bioprocess expertise to deliver life-changing therapies for people living with rare diseases?
Join a manufacturing team where precision, ownership, and cross-functional collaboration turn complex science into reliable supply for patients who count on us.
In this shift-based role, you will become fully trained and competent across core operations and develop a specialist focus where you lead improvements for your area.
Do you thrive in a fast-moving environment where you mentor others, resolve deviations, and elevate standards in cGMP every day?
Your impact will be felt on the floor and, ultimately, by patients whose journeys drive our mission.
Accountabilities -Core Production Operations: Independently perform cell culture, media preparation, purification, buffer preparation, and equipment preparation to deliver consistent, compliant batches.
-cGMP Execution and Documentation: Execute all tasks according to SOPs and batch records with full attention to detail and excellent documentation, safeguarding product quality and patient safety.
-Area Specialism and Technical Leadership: Develop subject matter expertise in at least one operational area and act as a Champion, leading improvements and excellence within the shift team.
-Deviation and Change Control: Assist with investigations of operational deviations through the QTS system; lead and own investigations and change controls when required to restore control and prevent recurrence.
-Training and Knowledge Transfer: Mentor colleagues in SOPs, process execution, and equipment operation; act as designee to prepare and deliver shift handovers, reporting to leadership, technical services, and engineering stakeholders.
-Stakeholder Engagement: Engage with Technical Services, QA, and Automation to resolve issues; interface effectively with MCS to anticipate, diagnose, and troubleshoot operational challenges.
-Validation and Start-up Support: Assist in facility and equipment start-up and validation; provide input on installation, start-up, operation, and troubleshooting to support new product introduction into sustaining operations.
-Lean and Continuous Improvement: Demonstrate a Lean mindset and lead by example, driving standard work, waste reduction, and process stability.
-EHS, GMP, and Productivity: Be a positive example in environmental health and safety, GMP compliance, and productivity to support a high-performance culture.
-Shift Operations: Work a varied shift pattern that typically includes weekends and periodic rotation between day and night, aligning with business requirements.
Essential Skills/Experience - Trained and competent to independently perform core production tasks in cell culture, media preparation, purification, buffer preparation, and equipment preparation.
- Responsible for execution of all tasks according to SOPs and batch records in a cGMP environment, ensuring full attention to detail and excellent documentation skills.
- High level of SME knowledge and experience in at least one area of operations (e.g., Level 1/Level 2); effective process leader within that area.
- Able to anticipate and troubleshoot operational issues and interface effectively with MCS.
- Engage with stakeholders including Technical Services, QA, and Automation to resolve issues.
- Willing to seek the schedule, identify priorities, and organise work teams locally.
- Be a mentor and a trusted source of knowledge, able to effectively impart information and knowledge to others.
- Be a positive example to others in all areas of EHS, GMP, and productivity.
- Able to act as designee if required to prepare and deliver shift handovers, reporting out to Biologics LT/TS/Eng.
- Lead and own investigations and change controls if required; assist with the investigation of operations deviations through the QTS system.
- Demonstrate a Lean mindset and lead by example in this area.
- Shift working required, including weekend working and periodic rotation between day and night shifts; shift pattern may vary according to business requirements.
Desirable Skills/Experience - Cross-trained across multiple unit operations, with flexibility to move between cell culture and downstream purification as needed.
- Experience with electronic systems supporting manufacturing (e.g., QTS, MCS) and familiarity with data-driven troubleshooting.
- Exposure to equipment installation, qualification, and validation, including start-up of new lines or technologies.
- Proven contributions to SOP and batch record creation or optimization.
- Formal training in root cause analysis, problem-solving, or Lean/continuous improvement methodologies.
- Strong communication skills to engage confidently with QA, Technical Services, Automation, and operations leadership during investigations and handovers.
Why AstraZeneca Here you will help deliver therapies for people often overlooked by the healthcare system, guided by their lived experiences and needs.
We bring unexpected teams into the same room—operators, engineers, quality specialists, and automation experts—to unleash bold thinking and build reliable, scalable manufacturing.
You will work with cutting-edge biologics processes and digital tools, in a culture that values kindness alongside ambition and supports you to lead improvements that matter for patients and for your growth.
Call to Action If you're ready to lead on the line, elevate standards, and turn rigorous cGMP execution into real impact for patients, take the next step and apply today!
Date Posted 03-Feb-**** Closing Date 17-Feb-****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.