AAVantgarde is a clinical-stage biotechnology company advancing best-in-class therapies for patients with inherited retinal diseases. The company’s lead programs target Stargardt disease and retinitis pigmentosa due to Usher syndrome type 1B—two severe inherited retinal diseases with no approved treatments. With a strong foundation in translational science and a commitment to clinical excellence, AAVantgarde is working to bring transformative therapies to patients.
The Role
We are looking for an accomplished bioprocessing scientist to join our growing team as Head of Process Development (PD) & Manufacturing Science and Technology (MSAT). This is a unique strategic and technical opportunity for an individual with significant late stage development, process characterisation, and validation experience in biotechnology and viral vector production.
In this role, you will manage a team of 4-5 experienced AAV PD/MSAT scientists to direct the optimization of our platform process, drive manufacturing science activities, and architect the overarching strategy for process characterisation and validation to enable commercial readiness. You will act as the key technical interface across analytical, research, quality, and regulatory functions while managing activities at CDMOs.
Specific responsibilities
- Define, execute, and oversee the strategy for Process Characterisation and Process Performance Qualification (PPQ) of AAV Drug Substance and Drug Product.
- Provide technical and manufacturing oversight for the sourcing and qualification of raw and starting materials (cell banks, plasmids, critical reagents and consumables).
- Accountable for upstream, downstream, and Drug Product fill/finish activities at external partners, ensuring successful technology transfer and routine GMP production.
- Establish the commercial Process Control Strategy, mapping CPPs to CQAs using qualified scale-down models.
- Partner with Research and Vector Design teams to transition early-stage pipeline assets into scalable, robust manufacturing platforms.
- Continue to develop the existing USP and DSP platform process and identify opportunities to optimize the Cost of Goods Manufactured (COGs).
- Review CMC source documents and regulatory filing dossiers (IND/IMPD/BLA/MAA). Review and sign off on process descriptions, risk assessments (FMEAs), validation protocols, and final study reports.
- Work with internal stakeholders and CDMO partners to ensure uninterrupted supply of materials from pre-clinical studies through all phases of clinical evaluation.
- Provide technical expertise on investigations into deviations and OOS (Out of Specification) results. Collaborate with QA on vendor qualification and change controls, and serve as the subject matter expert during regulatory inspections.
- Manage, develop, and mentor a high-performing team of 4-5 scientific staff.
Education and Qualification
- BSc in biochemical engineering, biological or pharmaceutical sciences with relevant post graduate qualification (or equivalent professional qualification or accreditation)
- Substantial industrial experience in biotechnology process development & GMP manufacturing of viral (gene therapy) and microbial (DNA) products
Skills and Capabilities
- Proven track record in managing CDMOs and external partner relationships.
- Experience in cell line development and characterisation
- Deep technical expertise in the processing of viral vectors (AAV preferred) or advanced therapies.
- Strong mastery of statistical tools (DoE, SPC) and Quality by Design (QbD) principles applied to process validation.
- Understanding of late-stage fill/finish requirements for low volume biotechnology products
- Comprehensive knowledge of CMC regulations and global registration processes (from IND to BLA/NDA). Commercial experience is desirable.
- Orphan drug or accelerated development timeline experience is highly desirable.
- Demonstrated ability to lead, mentor and develop a small team of direct reports, fostering strong performance, growth and engagement.
- Excellent interpersonal & organizational skills, project management skills & ability in problem solving
- Attention to detail with documentation and coordination/oversight practices
- Demonstrated ability to identify critical program risks and develop mitigation plans
- Ability to prioritize multiple tasks and act decisively
- Team approach to programme management
- Able to work both independently and collaboratively in a team
- Able to influence others and lead complex projects
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