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For Companies At a Glance
- Tasks: Support process validation and Continued Process Verification for advanced cell and gene therapy manufacturing.
- Company: Join Autolus Therapeutics, a diverse employer committed to inclusivity and innovation in biotechnology.
- Benefits: Enjoy hands-on experience, skill development, and opportunities for continuous improvement in a GMP environment.
- Why this job: Be part of a dynamic team driving quality and productivity in cutting-edge therapies that make a difference.
- Qualifications: 2-5 years in GMP manufacturing; Bachelor's degree in science or engineering preferred.
- Other info: Work based in Stevenage with occasional travel to London; ideal for those passionate about data-driven decisions.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
We are seeking a motivated and detail-oriented MSAT Technical Associate II to join our Manufacturing Science and Technology (MSAT) team. In this role, you will play a key part in supporting process validation activities and Continued Process Verification (CPV) for our advanced cell and gene therapy manufacturing processes. You will collaborate cross-functionally with Process Development, Manufacturing, Quality Assurance, and Quality Control to ensure processes are robust, compliant, and capable of consistently delivering high-quality products. This is a hands-on technical role ideal for someone passionate about data-driven decision-making and continuous improvement in a GMP environment.
The Autolus MSAT team primarily supports Manufacturing Operations in providing front line expert support for all process-specific issues to manufacturing, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to GMPs, SOPs and applicable guidelines and functional standards. This role is a great opportunity to develop key skills and grow within MSAT’s subgroups supporting technology transfer and introduction of new process, material, equipment, continuous improvement and automation projects, data science with continued process verification. The ideal candidate will have experience in Advanced Therapy Medicinal Product manufacturing and the role will be based between Stevenage and occasional work in London.
Key Responsibilities
- Provide frontline technical and scientific support as Subject Matter Expert (SME) in the manufacturing processes, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the standard procedures and quality requirements
- Provide on-call and on the floor support during technology transfer and routine manufacturing
- Provide product impact assessments and root cause analysis for less complex deviations, write and implement suitable corrective and preventative actions
- Contribute to commercial readiness activities
- Contribute to (risk) assessment of technical changes to ensure adherence to process specification and process control strategy and alignment of with batch records and procedures
- Review documentation such as batch manufacturing records, bill of materials, sampling plans, and material specifications
- Contribute with the assessment of new equipment and materials for GMP implementation
- Contribute to the change implementation of simpler MSAT-owned projects and execution of process improvements
- Contribute to data entry and verification of process parameters for the purpose of data analysis, monitoring, and trending to ensure that the products manufactured conform to expected critical process parameters and set product specifications
- Represent MSAT as an SME on smaller cross functional teams and projects
- Contribute to the execution of technology transfer of new products from process development into GMP manufacturing
- Other duties as required
Demonstrated skills and competencies
E- Essential
P- Preferred
Experience
- 2-5 years’ experience in GMP manufacturing (E)
- Experience in equipment and/or processes in a GMP manufacturing environment (P)
- Experience in Advanced Therapy Medicinal Product manufacturing (P)
- Experience in technology transfer and process/product lifecycle management (P)
Qualifications
- Bachelor’s degree in science, engineering, or relevant degree (P)
Skills/Specialist knowledge
- Knowledge and understanding of Good Manufacturing Practices (GMP) (E)
- Excellent technical writing skills, strong communication and interpersonal skills with ability to work independently and cross functionally with internal and external stakeholders(E)
- Key attributes such as simplifying the complex, making data-driven decisions, problem solving, and collaborating cross functionally (E)
- Problem solving mindset with the ability to shift focus based on changing priorities(E)
- Knowledge and understanding of regulatory policies (P)
- Experience working in cross functional technical transfer activities with ability to multitask, prioritize and be an effective decision maker (P)
- Experience in Quality Management Systems, initiation/owning and completing deviations, change controls and CAPAs (P)
- Experience in writing or revising procedures to support project implementation and process improvement initiatives (P)
- Utilize and incorporate principles of Lean, Six Sigma, or other relevant operational excellence methodologies to the manufacturing processes (P)
- Experience and interest in biotechnology, pharmaceutical or cell and gene therapy industry (P)
- Experience in aseptic processing, cell culture and downstream processing (P)
- Experience in data analysis tools and data management platforms(P)
- Experience in automation projects (P)
#LI-DNI
Technical Associate II - MSAT (CPV, Process Validation SME) employer: Autolus Therapeutics
Contact Detail:
Autolus Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Technical Associate II - MSAT (CPV, Process Validation SME)
✨Tip Number 1
Familiarise yourself with Good Manufacturing Practices (GMP) and the specific processes used in Advanced Therapy Medicinal Product manufacturing. Understanding these concepts will help you speak confidently about your knowledge during interviews.
✨Tip Number 2
Network with professionals in the biotechnology and pharmaceutical industries, especially those involved in cell and gene therapy. Engaging with industry experts can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with technology transfer and process validation. Be ready to share specific examples of how you've contributed to these areas in previous roles, as this will demonstrate your hands-on expertise.
✨Tip Number 4
Showcase your problem-solving skills by preparing examples of how you've tackled complex issues in a GMP environment. Highlighting your ability to make data-driven decisions will resonate well with the hiring team.
We think you need these skills to ace Technical Associate II - MSAT (CPV, Process Validation SME)
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Technical Associate II position. Understand the key responsibilities and required skills, especially those related to GMP manufacturing and process validation.
Tailor Your CV: Customise your CV to highlight relevant experience in GMP manufacturing and Advanced Therapy Medicinal Products. Emphasise your technical writing skills and any experience with technology transfer or process improvement initiatives.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for data-driven decision-making and continuous improvement. Mention specific examples from your past experiences that align with the responsibilities of the role.
Highlight Relevant Skills: In your application, clearly outline your knowledge of Good Manufacturing Practices (GMP) and any experience with Quality Management Systems. Mention your problem-solving mindset and ability to work cross-functionally, as these are crucial for the role.
How to prepare for a job interview at Autolus Therapeutics
✨Showcase Your Technical Expertise
Be prepared to discuss your experience in GMP manufacturing and Advanced Therapy Medicinal Products. Highlight specific projects where you provided technical support or contributed to process validation activities, as this will demonstrate your suitability for the role.
✨Emphasise Problem-Solving Skills
Prepare examples of how you've tackled complex issues in a manufacturing environment. Discuss your approach to root cause analysis and corrective actions, as well as any experience with technology transfer and process improvements.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working with various teams, be ready to share experiences where you successfully collaborated with different departments. Highlight your communication skills and ability to work independently while still being a team player.
✨Familiarise Yourself with Regulatory Standards
Brush up on Good Manufacturing Practices (GMP) and relevant regulatory policies. Being knowledgeable about these standards will not only help you answer questions confidently but also show your commitment to compliance and quality in manufacturing.
