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- Tasks: Lead analytical development for innovative RNA-based therapeutics and shape strategies for drug candidates.
- 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, collaborative environment with significant career advancement potential.
- Why this job: Make a real impact in advancing novel therapeutics from preclinical to clinical stages.
- Qualifications: Experience in analytical development and knowledge of regulatory requirements.
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.
- 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 in Peterborough employer: Barrington James Limited
Contact Detail:
Barrington James Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Analytical CMC Lead in Peterborough
✨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 about potential job openings.
✨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 during interviews and demonstrate your hands-on expertise.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your responses, especially around regulatory expectations and CMC strategies. The more comfortable you are, the better you'll perform.
✨Tip Number 4
Apply through our website! We’re always on the lookout for passionate individuals who want to make an impact in the biotech space. Don’t miss out on the chance to join us and shape the future of therapeutics!
We think you need these skills to ace Analytical CMC Lead in Peterborough
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, so we get a sense of who you are.
Showcase Your Achievements: When detailing your past experiences, focus on specific achievements that demonstrate your expertise in analytical methods and regulatory compliance. We love numbers and results, so if you’ve improved processes or led successful projects, let us know!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
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 and LC-MS/MS. 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. Being able to articulate how your experience aligns with regulatory requirements will show that you're not just technically skilled but also aware of the bigger picture.
✨Showcase Your Strategic Thinking
This role requires a blend of strategic ownership and hands-on input. Prepare examples of how you've developed analytical strategies in past projects, especially in fast-paced environments. Highlight your ability to adapt and innovate under pressure.
✨Prepare Questions for Them
Interviews are a two-way street! Think of insightful questions about their pipeline and how they envision the analytical framework evolving. This shows your genuine interest in the role and helps you assess if it's the right fit for you.