At a Glance
- Tasks: Lead analytical development for innovative siRNA programmes and establish quality frameworks.
- Company: Aerska, a pioneering biotechnology company focused on RNA therapeutics.
- Benefits: Competitive salary, opportunities for professional growth, and a dynamic work environment.
- Other info: Join a fast-paced team dedicated to groundbreaking scientific advancements.
- Why this job: Make a real impact in advancing cutting-edge therapies and shaping the future of medicine.
- Qualifications: Experience in oligonucleotide or RNA therapeutics and strong leadership skills.
The predicted salary is between 70000 - 90000 € per year.
We are seeking an experienced professional to lead CMC analytical development as Aerska advances its siRNA programmes toward IND/CTA filing and first-in-human studies. This is a foundational hire that will define Aerska's analytical strategy, establishing the methods and quality frameworks required to characterise novel brain shuttle-siRNA conjugates and take them into the clinic.
With support, the successful candidate will be responsible for the analytical development function, working closely with chemistry, process development, and translational science teams internally, and managing external CRO and CDMO partners who will deliver much of the programme's analytical work. This is a hands-on scientific leadership role suited to a scientist who has navigated the full arc from early characterisation through GMP qualification for oligonucleotide or RNA therapeutics, and who thrives in the fast-moving, resource-constrained environment of a pre-clinical biotechnology company.
Key Responsibilities- Lead Aerska's CMC analytical strategy for siRNA drug substance and drug product, encompassing identity, purity, potency, stability, and safety-relevant attributes.
- Develop and implement phase-appropriate analytical methods for the characterisation of siRNA and brain shuttle-siRNA conjugates, including orthogonal techniques such as IP-RP-HPLC, IEX, SEC, CE, LC-MS/MS, UV-Vis spectroscopy, and cell based assay.
- Establish impurity profiling strategies appropriate to the unique chemistry and conjugation of Aerska's delivery platform, including process-related and product-related degradation impurities.
- Design and manage forced degradation and accelerated stability studies to characterise product degradation pathways and support shelf-life determination.
- Lead the development and qualification of analytical methods at CDMOs to support IND/CTA submissions in line with ICH guidelines and regulatory expectations from MHRA and FDA.
- Establish release and stability indicating methods for non-GMP and GMP-grade material, and oversee the qualification and transfer of methods to GMP-compliant analytical environments.
- Contribute analytical data packages and CMC sections to regulatory documents including IND/IMPDs, pre-IND briefing documents, and responses to health authority questions.
- Develop and maintain drug substance and drug product specifications appropriate to each development stage.
Analytical CMC Lead in Lincolnshire employer: Aerska, Inc.
Aerska is an exceptional employer for those looking to make a significant impact in the biotechnology field, particularly in the exciting realm of siRNA therapeutics. With a strong emphasis on innovation and collaboration, employees benefit from a dynamic work culture that fosters professional growth and development, while also enjoying the unique opportunity to shape the future of cutting-edge drug development in a supportive and resourceful environment. Located in a vibrant area, Aerska offers a stimulating workplace where scientific leaders can thrive and contribute to meaningful advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Analytical CMC Lead in Lincolnshire
✨Tip Number 1
Network like a pro! Reach out to professionals in the biotech field, especially those who have experience with CMC analytical development. Attend industry events or webinars, and don’t be shy about sliding into DMs on LinkedIn. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and being ready to discuss specific methodologies like IP-RP-HPLC or LC-MS/MS. We recommend practising common interview questions and even doing mock interviews with friends or mentors. Show them you’re not just a scientist, but the right scientist for Aerska!
✨Tip Number 3
Don’t forget to showcase your hands-on experience! When you get the chance to chat with potential employers, highlight your past projects and how you’ve navigated the complexities of analytical development. We want to see that you can lead the charge in a fast-paced environment.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are genuinely interested in joining our team. So, take that extra step and let us know why you’re excited about the role!
We think you need these skills to ace Analytical CMC Lead in Lincolnshire
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in CMC analytical development. We want to see how your skills align with the role, so don’t be shy about showcasing your expertise in oligonucleotide or RNA therapeutics!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the Analytical CMC Lead position. Share specific examples of your past work that relate to the responsibilities outlined in the job description.
Showcase Your Leadership Skills:Since this is a hands-on scientific leadership role, make sure to highlight any previous leadership experiences. We’re looking for someone who can lead teams and manage external partners effectively, so share those stories!
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Aerska, Inc.
✨Know Your Analytical Techniques
Make sure you brush up on the specific analytical methods mentioned in the job description, like IP-RP-HPLC and LC-MS/MS. Be ready to discuss your experience with these techniques and how you've applied them in previous roles.
✨Understand Regulatory Expectations
Familiarise yourself with ICH guidelines and the regulatory processes for IND/CTA submissions. Being able to speak knowledgeably about these will show that you’re not just technically skilled but also aware of the bigger picture in drug development.
✨Showcase Leadership Experience
Since this role involves leading the analytical strategy, be prepared to share examples of how you've successfully led teams or projects in the past. Highlight your ability to manage both internal teams and external partners like CROs and CDMOs.
✨Prepare Questions About the Company
Have a few thoughtful questions ready about Aerska's siRNA programmes and their future direction. This shows your genuine interest in the company and helps you assess if it’s the right fit for you.
