Jobs at Asklepios Biopharmaceutical

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.

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.

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.

Develop and maintain detailed maintenance schedules using CMMS/Microsoft Project, coordinate with maintenance, engineering, procurement and operations, track progress and variances, produce reports and forecasts, ensure resource allocation, and identify/mitigate schedule risks to support timely completion of maintenance tasks.

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 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 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.

Support GMP-compliant QC and Analytical Development lab operations including sample shipment/receipt/storage, equipment maintenance (CMMS), inventory management, vendor coordination, budget and contract support, authoring deviations/CAPAs/change controls, SOP creation/revision, data review, and regulatory interactions as lab operations subject matter expert.