At a Glance
- Tasks: Lead analytical development for innovative RNA-based therapeutics and ensure regulatory compliance.
- Company: Rapidly emerging biotechnology company focused on cutting-edge RNA therapeutics.
- Benefits: Competitive salary, dynamic work environment, and opportunities for professional growth.
- Other info: Fast-paced role with strategic ownership and hands-on scientific input.
- Why this job: Make a real impact in advancing novel therapeutics from lab to clinic.
- Qualifications: Experience in analytical development and knowledge of oligonucleotide drug candidates.
The predicted salary is between 60000 - 80000 € per year.
A rapidly emerging biotechnology company developing RNA-based therapeutics is seeking a CMC analytical lead to support the progression of its pipeline toward IND/CTA submission and early clinical studies. This is a high-impact role responsible for shaping the analytical development strategy for complex oligonucleotide-based drug candidates, including conjugated delivery systems targeting the central nervous system. The successful candidate will play a key role in building the analytical framework, methodologies, and quality approach required to advance novel therapeutics from preclinical development into the clinic. Operating within a lean, fast-paced environment, this position offers the opportunity to combine strategic ownership with hands-on scientific input, working closely with both internal teams and external partners.
Key Responsibilities
- Analytical Development & Strategy
- Define and execute the CMC analytical strategy for oligonucleotide drug substance and drug product.
- Establish methods to assess identity, purity, potency, stability, and critical quality attributes.
- Develop phase-appropriate analytical techniques for RNA-based therapeutics and conjugated systems.
- Apply a range of analytical platforms, including HPLC (IP-RP), IEX, SEC, CE, LC-MS/MS, and spectroscopic and cell-based assays.
- Design impurity profiling strategies, addressing both process- and product-related impurities.
- Lead forced degradation and stability studies to understand degradation pathways and inform shelf-life.
- Regulatory & IND/CTA Readiness
- Support IND/CTA-enabling activities, ensuring analytical methods align with regulatory expectations.
- Oversee method qualification and transfer into GMP-compliant environments.
- Contribute to regulatory documentation, including CMC sections of IND/IMPD submissions and briefing packages.
- Define specifications for drug substance and drug product across development stages.
- Support responses to health authority queries (e.g. MHRA, FDA).
Analytical CMC Lead employer: Barrington James Limited
Join a pioneering biotechnology company at the forefront of RNA-based therapeutics, where your expertise as an Analytical CMC Lead will directly influence the development of groundbreaking treatments. Our collaborative and dynamic work culture fosters innovation and personal growth, providing you with the unique opportunity to shape analytical strategies while working alongside passionate professionals in a fast-paced environment. With a commitment to employee development and a focus on impactful projects, this role offers a rewarding career path in a location that champions scientific advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Analytical CMC Lead
✨Tip Number 1
Network like a pro! Reach out to professionals in the biotech field, especially those working with RNA-based therapeutics. Attend industry events or webinars to make connections and learn more about the latest trends.
✨Tip Number 2
Showcase your skills! Prepare a portfolio that highlights your experience with analytical techniques like HPLC and LC-MS/MS. This will give you an edge when discussing your hands-on scientific input during interviews.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews focusing on CMC analytical strategies and regulatory readiness. This will help you articulate your thoughts clearly and confidently when it comes to IND/CTA submissions.
✨Tip Number 4
Apply through our website! We love seeing candidates who are genuinely interested in joining our team. Make sure to tailor your application to highlight your strategic ownership and analytical development experience.
We think you need these skills to ace Analytical CMC Lead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Analytical CMC Lead role. Highlight your experience with oligonucleotide-based therapeutics and any relevant analytical techniques you've used. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about RNA-based therapeutics and how you can contribute to our analytical development strategy. Keep it engaging and personal – we love a good story!
Showcase Your Technical Skills:In your application, don't forget to showcase your technical expertise with analytical platforms like HPLC, LC-MS/MS, and others mentioned in the job description. We’re looking for someone who can hit the ground running, so let us know what you bring to the table!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates directly from us. Plus, it shows you're keen on joining our team!
How to prepare for a job interview at Barrington James Limited
✨Know Your Analytical Techniques
Make sure you brush up on the analytical techniques mentioned in the job description, like HPLC, LC-MS/MS, and others. Be ready to discuss how you've applied these methods in your previous roles and how they can be tailored for RNA-based therapeutics.
✨Understand Regulatory Expectations
Familiarise yourself with the regulatory landscape surrounding IND/CTA submissions. Knowing the ins and outs of what health authorities like the MHRA and FDA expect will show that you're not just technically skilled but also aware of the bigger picture.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to solve hypothetical problems related to analytical development and strategy. Think about past experiences where you had to design impurity profiling strategies or lead stability studies, and be ready to explain your thought process.
✨Show Your Collaborative Spirit
This role involves working closely with internal teams and external partners. Be prepared to share examples of how you've successfully collaborated in a fast-paced environment, highlighting your ability to communicate effectively and drive projects forward.
