Analytical CMC Lead

22h

About The Position

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.

Requirements

PhD in Analytical Chemistry, Biochemistry, Biophysics, Pharmaceutical Sciences, or a related field.
Significant industry experience in CMC analytical development for oligonucleotide or RNA therapeutics (siRNA, ASO, mRNA, or related modalities).
Demonstrated experience developing and qualifying analytical methods for nucleic acid drug substances and drug products, including purity, identity, potency, and stability assays.
Hands-on expertise with relevant analytical platforms, including IP-RP-HPLC, IEX, SEC, CE, and LC-MS/MS for oligonucleotide characterisation.
Experience supporting IND or CTA filings, including contributing to CMC regulatory submissions and IMPD/IND analytical sections.
Experience managing external CRO/CDMO partners and overseeing analytical method transfer in a development context.
Familiarity with ICH guidelines relevant to oligonucleotide CMC (Q2, Q14 and Q6B) and awareness of the current regulatory landscape for RNA-based therapeutics.
Ability to operate effectively in a small-company environment, balancing strategic ownership with hands-on technical engagement as required.

Nice To Haves

Experience with novel delivery systems and drug product

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 CDMOsto 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.
Contribute to the selection of CDMOs and analytical CROs responsible for method development, GMP testing, and stability programme execution.
Oversee technology transfer of analytical methods to external partners and ensure robust method transfer documentation and comparability assessments.
Define analytical requirements for CDMO-manufactured material and ensure that deliverables meet Aerska's quality and timeline expectations.
Serve as the primary analytical interface with external manufacturing and testing partners.