At a Glance
- Tasks: Manage stability studies and ensure compliance with regulatory guidelines for gene therapy products.
- Company: Join a leading biotech firm dedicated to innovative gene therapy solutions.
- Benefits: Competitive salary, career growth opportunities, and a collaborative work environment.
- Other info: Dynamic role with opportunities for continuous improvement and professional development.
- Why this job: Make a real impact in the biotech industry while advancing your career.
- Qualifications: 5 years in Pharma/Biotech, strong analytical skills, and team management experience.
The predicted salary is between 51750 - 63250 £ per year.
Your mission
The Stability Manager is responsible for managing all aspects of the stability program across all projects and UK and Ireland sites, including initiating and managing stability studies, protocol development and maintenance, data monitoring, trending and reporting.
Job Description
- Major Activities
- Designs, coordinate, and execute stability studies for clinical and commercial gene therapy products according to regulatory guidelines and company protocols.
- Generate stability reports by applying analytical testing expertise to ensure scientific and technical excellence.
Utilize statistical software like JMP to perform rigorous statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards.
- Authors, reviews, revises, and approves SOP's, stability protocols and reports, memo’s, regulatory and specification documents (as required).
- The Stability Manager will also assist with leading the functionality and maintenance of stability related processes and systems.
- Drives continuous improvement activities for the stability programs.
- Ensures that the GMP stability program continuously aligns with FDA, ICH and other international agencies.
- Manages Quality Systems records for QC Stability- creates, assesses, reviews Deviations, Change Controls, CAPA's and other applicable stability-related investigations and events.
- Guide and work with others to identify opportunities for continuous improvement and implement/maintain solutions.
- Provide strong teamwork in establishing a quality culture and shared accountability.
Ensure GMP compliance is built into the design and implementation of processes and systems, including tracking metrics to monitor and improve performance.
- Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
- Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken.
- Responsible for ensuring that any GMP documentation e. g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.
- Job Background
- 5 years of relevant industry experience in Pharma / Biotech industry required.
- Strong understanding of gene therapy stability principles, including degradation pathways, accelerated stability testing, and shelf-life determination.
- Proven experience in managing staff.
- Demonstrated proficiency and expertise in various analytical methodologies, particularly in the context of stability testing and assessment of biologics or gene therapy.
- Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation for biologics and gene therapy.
- Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/ shelf-life proposals.
- Attention to detail and excellent skills in record keeping / documentation.
- Experience in IND, NDA and BLA submission is highly preferred.
- Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
- Solid understanding of product development activities in biotech/drug/gene therapy development, including key interdependencies, and knowledge of proven development strategies and tactics.
- To travel to other Meira sites when required.
Why us?
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QC Stability Manager employer: Meiragtx
MeiraGTx is an excellent employer that values precision and compliance in the pharmaceutical industry, offering a supportive work culture where attention to detail is rewarded. Employees benefit from professional growth opportunities and the chance to contribute to meaningful projects in a dynamic environment, all while being part of a team dedicated to advancing gene therapies in a vibrant location.
StudySmarter Expert Advice🤫
We think this is how you could land QC Stability Manager
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Meiragtx. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Meiragtx.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Meiragtx. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Meiragtx is looking for. A tailored application can really make you stand out!
We think you need these skills to ace QC Stability Manager
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Meiragtx!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Meiragtx that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Meiragtx!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Meiragtx, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Meiragtx
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Meiragtx that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Meiragtx’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
