Associate Director​/Director, Downstream Process Development & Formulation – LNP and Nanoparticles

Drive the Next Generation of Gene Editing Delivery

Helix Bio Search is partnering with an innovative biotechnology company developing next-generation targeted delivery technologies for in vivo gene editing. Combining advanced nanoparticle engineering with cutting-edge therapeutic development, the company is building a platform designed to overcome one of the biggest challenges in genetic medicine: safe and precise delivery.

We are seeking an experienced Associate Director or Director of Formulation & Downstream Process Development to provide scientific leadership across downstream process development for a targeted lipid nanoparticle (LNP) platform. This is a highly visible opportunity for a technical expert who enjoys remaining hands‑on in the laboratory while shaping CMC strategy and supporting the advancement of novel therapeutics from discovery through clinical development.

Working closely with Formulation, Analytical Development, Biology, Manufacturing and Regulatory teams, you will lead the development of robust, scalable purification and formulation processes that preserve nanoparticle integrity while enabling successful technology transfer and manufacturing scale‑up.

• Lead the development and optimization of scalable downstream manufacturing processes for targeted lipid nanoparticle (LNP) therapeutics, from early research through process scale‑up.
• Establish robust purification strategies using technologies such as tangential flow filtration (TFF), size exclusion chromatography (SEC) and other appropriate downstream processing techniques.
• Drive improvements in process efficiency, product recovery and overall manufacturability while maintaining nanoparticle quality, functionality and stability.
• Partner with Analytical Development to evaluate critical quality attributes using a range of nanoparticle characterization techniques and apply findings to process refinement.
• Develop formulation and buffer systems that maximize product stability, storage performance and suitability for clinical manufacturing.
• Apply data‑driven process development methodologies, including Design of Experiments (DoE), to identify optimal operating conditions and establish scalable manufacturing processes.
• Define and characterise critical process parameters (CPPs) and critical quality attributes (CQAs) to support process understanding, regulatory readiness and future validation activities.
• Assess and introduce new purification technologies and downstream processing approaches that enhance platform capability and manufacturing efficiency.
• Lead process transfer activities with external manufacturing partners, providing technical guidance, documentation and troubleshooting throughout technology transfer.
• Work closely with cross‑functional teams across Formulation, Biology, Analytical Development, Manufacturing and Regulatory Affairs to ensure downstream processes support overall product performance and development timelines.
• Contribute to CMC strategy, regulatory documentation and manufacturing readiness as programs advance towards clinical development.
• Provide technical leadership across multiple development programs while mentoring scientists and helping shape the future direction of the company’s downstream processing capabilities.

• A PhD in Chemical Engineering, Biomedical Engineering, Pharmaceutics, Chemistry, Biochemistry or a related scientific discipline (or equivalent industry experience).
• A strong track record developing downstream processes for lipid nanoparticles, advanced drug delivery systems or other complex biologic products within an industry setting.
• Extensive hands‑on experience with TFF, SEC and other downstream purification technologies used to support process development and manufacturing scale‑up.
• Broad understanding of nanoparticle formulation, analytical characterization and factors influencing stability, recovery and product quality.
• Experience designing statistically driven experiments (DoE) to optimize processes and support robust manufacturing development.
• Familiarity with CMC development, technology transfer and preparation of processes for GMP manufacturing.
• A…