Jobs at Asklepios Biopharmaceutical

Lead translational medicine pathology and nonclinical safety for gene therapy programs. Act as PI for pathology in GLP/non-GLP studies, provide histopathology and peer review, interpret nonclinical data, guide study design and regulatory submissions, manage internal pathology staff, and collaborate cross-functionally with discovery, development, clinical, and regulatory teams.

Lead analytical control strategies and lifecycle management for gene therapy products. Develop, validate, transfer, and troubleshoot complex bioanalytical methods (PCR/ddPCR, ELISA, NGS, HPLC, AUC, cell-based assays). Oversee tech transfers with CDMOs/CROs, support quality investigations and CAPAs, author regulatory submission sections, and drive analytical innovation, automation, and inspection readiness across programs.

Lead independent initiatives to optimize DNA manufacturability and quality for rAAV production. Design and test DNA constructs, develop DNA production methods, troubleshoot purification and analytics, author technical and regulatory documents, collaborate across teams, mentor staff, and perform hands-on lab work as needed.

Lead global clinical development for the GDNF program, co-chair the Clinical Sub-team, build and manage a team of medical directors, design and oversee clinical trials across phases, ensure regulatory filings and safety monitoring, partner cross-functionally to support BLA/MAA submissions and product launch, engage external stakeholders and patient groups, and contribute to clinical strategy, budgeting, and risk mitigation for CNS gene therapy programs.

Lead AskBio's AI and digital innovation portfolio: scout technologies, shape and prioritize use cases, own product roadmaps, lead a small delivery team, ensure GxP-compliant experimentation and adoption, and drive value realization across R&D, Technical Operations, Therapeutics, and enabling functions.

Manages end-to-end clinical data management for gene therapy trials, including database design, programming, UAT, deployment, data review, coding, database lock, archiving, and vendor oversight. Ensures data quality, integrity, regulatory compliance, and timely delivery. Serves as the data management contact for cross-functional teams, supports inspections and audits, manages protocol-driven changes, develops analytical utilities, and contributes to procedures and guidance documents.

Plans and schedules maintenance, calibration, corrective, and utilities work in a GxP-regulated biotech environment. Owns CMMS planning data, job plans, preventive maintenance schedules, spare-parts records, dashboards, and performance metrics. Coordinates resources, vendors, materials, shutdowns, compliance requirements, and cross-functional stakeholders. Supports CMMS migration, reliability reviews, audits, training, and continuous improvement across facilities, laboratory, utility, and maintenance operations.

Leads biodistribution and gene expression strategies for gene therapy programs. Designs, develops, and executes molecular assays including qPCR, ddPCR, and RT-qPCR; analyzes tissue and biofluid data; interprets vector distribution, persistence, and transgene expression; supports dose selection, safety assessment, regulatory submissions, and cross-functional development decisions.

Leads cell line and end-to-end process development for novel recombinant AAV platforms, including scale-up, purification, technology transfer, GMP cell bank qualification, process optimization, CMC documentation, regulatory submissions, budgeting, IP support, and team leadership. Partners with MSAT, CDMOs, and cross-functional technical operations teams while mentoring scientists and presenting findings internally and externally.

Lead U.S.-based regulatory strategy for assigned gene therapy programs, driving global submissions and health authority interactions (IND/CTA/PIND), preparing regulatory documents and briefing packages, advising cross-functional teams, managing external regulatory partners, and ensuring compliance with FDA, EMA, MHRA and other agency requirements throughout clinical development.

Support MSAT process engineering for gene therapy scale-up, technology transfer, and cGMP manufacturing. Develop/qualify small-scale models, design and analyze process characterization experiments, author protocols/reports, support investigations and PPQ readiness, maintain lab operations, and communicate technical results to stakeholders.

Perform and develop immunology assays on clinical samples to assess AAV immunogenicity. Lead assay development/validation, analyze and report data, author SOPs and validation reports, manage sample workflow, maintain GxP-compliant lab practices, and train junior staff while coordinating with clinical teams.

Develop, validate, and run neutralizing and total antibody assays on preclinical and clinical samples under GLP/GCLP/CLIA. Optimize protocols, analyze data with statistical/bioinformatics tools, prepare reports and regulatory documentation, write SOPs, collaborate cross-functionally, and mentor junior staff to support gene therapy programs.