Scientist II - HSV‑1 Viral Vector Process Development
About The Position
Replay Holdings, Inc. ("Replay"), now part of LEO Pharma, is advancing the future of gene therapy for patients with rare disease. Originally built as a preclinical gene therapy company focused on HSV-based vectors for topical dermatology applications, Replay combines the agility of a small, high-impact team with the global reach and patient commitment of LEO Pharma. Together, we are building the CMC capabilities needed to advance our lead program from pre-clinical development through IND submission and GMP clinical manufacturing. Our platform leverages the large payload capacity of HSV vectors (up to 150 kb) to deliver complex therapeutic genes, with the goal of bringing meaningful new treatment options to patients with high unmet needs.
Requirements
- BSc, MS or PhD in Chemical/Biochemical Engineering, Bioprocessing, Virology, Molecular Biology or a related discipline.
- 4+ years hands‑on experience in downstream process development for viral vectors or biologics, ideally including HSV‑1 or similar large DNA viral vectors.
- Demonstrated experience with TFF (membrane selection, diafiltration, fouling), depth/clarification filtration and column chromatography.
- Hands‑on experience operating and programming ÄKTA systems.
- Competent experimental design, data analysis and scientific communication skills.
Nice To Haves
- Experience supporting process characterisation and regulatory submissions preferred.
- Experience with scale‑up and tech‑transfer to GMP manufacturing (Desirable)
- Prior exposure to IND/IMPD filing support (Desirable)
- Familiarity with aseptic techniques and GMP expectations (Desirable)
Responsibilities
- Developing and optimizing downstream purification for HSV‑1 vectors, including depth filtration, TFF and chromatography.
- Planning and executing TFF development studies: membrane screening, diafiltration optimization, fouling characterization and defining operating ranges.
- Evaluating and improving harvest clarification strategies with a focus on scalability and robustness.
- Operating, programming and troubleshooting ÄKTA chromatography systems and leading chromatography screening campaigns.
- Designing experiments, analysing data quantitatively (statistical and process evaluation) and presenting results and next steps.
- Supporting upstream process development activities as required.
- Drafting and reviewing technical reports, protocols, batch records and technology transfer documents.
- Executing process characterisation studies to support regulatory filings (IND/IMPD).
- Maintaining detailed laboratory notebooks, confidently presenting data in group meetings and contributing to technical strategy discussions.
- Maintaining laboratory equipment and consumables inventory and observing safety and housekeeping standards.
Benefits
- Eligibility to earn commissions/bonus based on company and/or individual performance.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
