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- Tasks: Join our GMP manufacturing team as an Operator II, ensuring high-quality cell-based product production.
- Company: Autolus Therapeutics is an innovative biotech company focused on next-generation cell therapies.
- Benefits: Enjoy a full-time role with shift flexibility and opportunities for professional growth.
- Other info: This role involves weekend shifts and offers mentoring opportunities for junior team members.
- Why this job: Be part of a cutting-edge industry, making a real impact in healthcare while developing your skills.
- Qualifications: Minimum 2 years of GMP cleanroom experience required; teamwork and attention to detail are essential.
The predicted salary is between 30000 - 42000 £ per year.
Job Summary
Autolus is seeking a highly motivated Operator II to join our GMP manufacturing team. This shift-based role involves weekend working and operates across 6 AM – 10 PM. You will play a key role in ensuring the production of high-quality cell-based products while maintaining compliance with GMP regulations, safety standards, and company procedures.
Responsibilities
- Execute production processes and operate associated equipment in line with GMP and GDP requirements.
- Maintain cleanroom environments through sterile room maintenance, hydrogen peroxide vapour gassing, and environmental monitoring (EM).
- Conduct raw material transfers, particulate cleaning and disinfection, material receipt, and drug product shipment.
- Accurately complete documentation and data entry, ensuring compliance with regulatory standards.
- Perform cell culture activities including sampling, counting, washing, activation, feeding, harvesting, and magnetic enrichment/depletion (MACS).
- Carry out aseptic manipulations in Grade A environments and meet associated BROTH qualification (OAQ) standards.
- Support batch review execution and collaborate with cross-functional teams to ensure smooth workflow.
- Lead or support operational deviations, process risk assessments, and continuous improvement (CI) initiatives.
- Assist in the authoring and revision of SOPs, SWIs, and risk assessments to maintain process efficiency and compliance.
- Provide guidance and mentoring to junior team members, supporting their training and development.
Skills & Experience
- Minimum 2 years of GMP manufacturing cleanroom experience (essential).
- Experience working in shift-based, high-performance environments (preferred).
- Strong understanding of GxP, ATMP production, QMS, and environmental health & safety requirements.
- Ability to follow detailed instructions, work with attention to detail, and make quality-critical decisions.
- Proficiency in Microsoft Office (Word, Excel, Teams, PowerPoint) and familiarity with problem-solving methodologies like Lean Six Sigma (preferred).
- Excellent communication, teamwork, and organizational skills.
Working Pattern
- This is a shift-based role requiring weekend work.
- Shifts will fall within the operational hours of 6 AM – 10 PM.
This role offers an exciting opportunity to be part of an innovative biotech company, contributing to the manufacture of next-generation cell-based therapies. If you\’re passionate about GMP manufacturing and eager to make a difference, we’d love to hear from you!
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Operator II, Production employer: Autolus Therapeutics
Contact Detail:
Autolus Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Operator II, Production
✨Tip Number 1
Familiarise yourself with GMP regulations and standards. Understanding these will not only help you in the interview but also demonstrate your commitment to quality and compliance, which is crucial for the Operator II role.
✨Tip Number 2
Highlight any experience you have in cleanroom environments or with cell culture activities. Be ready to discuss specific examples of how you've maintained sterile conditions or executed production processes in previous roles.
✨Tip Number 3
Prepare to showcase your teamwork and communication skills. Since this role involves collaboration with cross-functional teams, think of instances where you've successfully worked with others to achieve a common goal.
✨Tip Number 4
Be ready to discuss your problem-solving abilities, especially in high-pressure situations. Familiarity with methodologies like Lean Six Sigma can set you apart, so consider how you've applied these principles in past experiences.
We think you need these skills to ace Operator II, Production
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the key responsibilities and required skills for the Operator II position. Tailor your application to highlight relevant experiences that align with these requirements.
Highlight Relevant Experience: Emphasise your GMP manufacturing cleanroom experience and any shift-based work you've done. Use specific examples to demonstrate your understanding of GxP, ATMP production, and compliance with safety standards.
Showcase Your Skills: Mention your proficiency in Microsoft Office and any familiarity with problem-solving methodologies like Lean Six Sigma. Highlight your communication and teamwork skills, as these are crucial for the role.
Craft a Strong Cover Letter: Write a compelling cover letter that expresses your passion for GMP manufacturing and your eagerness to contribute to Autolus Therapeutics. Make sure to connect your background and skills to the company's mission and values.
How to prepare for a job interview at Autolus Therapeutics
✨Understand GMP Regulations
Make sure you have a solid grasp of Good Manufacturing Practice (GMP) regulations. Be prepared to discuss how you've adhered to these standards in your previous roles, as compliance is crucial in this position.
✨Showcase Your Cleanroom Experience
Highlight your experience working in cleanroom environments. Be ready to provide specific examples of tasks you've performed, such as aseptic manipulations or environmental monitoring, to demonstrate your familiarity with the role's requirements.
✨Emphasise Team Collaboration
Since this role involves working with cross-functional teams, be sure to share examples of how you've successfully collaborated with others in past positions. This will show that you can contribute to a smooth workflow and support team objectives.
✨Prepare for Shift Work Discussion
As this is a shift-based role requiring weekend work, be prepared to discuss your availability and willingness to work during these hours. Showing flexibility and a positive attitude towards shift work can set you apart from other candidates.