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Associate Director/Director, Drug Substance, MSAT

King of Prussia, PA, US
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    Summary

    Manufacturing Science and Technology (MSAT) is a department within a Process Development Division in Center of Breakthrough Medicines. MSAT provides technical support for enabling readiness, robustness and GMP compliance of manufacturing processes for gene and cell therapy products. Associate Director/Director of MSAT, Drug Substance ensures that cell culture, cell selection, purification, isolation and formulation/bulk fill steps in drug substance manufacturing processes are optimized, scalable and compliant through strong collaboration and guidance from Process Development, Quality and Manufacturing teams.

    Responsibilities

    • Lead a team of Engineers and Scientists, who perform as drug substance manufacturing SMEs in support of Process Development and Manufacturing organizations.
    • Contribute to overarching Process Development goals to ensure the effective integration of process knowledge into manufacturing operations.
    • Work closely with Manufacturing team to ensure that drug substance operations are thoroughly supported by high quality process documentation (knowledge transfer, batch records, forms, SOPs), controlled processes and verified technology.
    • Responsible for change control ownership/assessment, investigations, product quality impact assessments, and other quality system deliverables.
    • Support viral vector and/or cell therapy manufacturing processes from early clinical phase through and commercial manufacturing.
    • Design and ensure DS process control strategies, including execution of process risk assessment, justification of process parameters range, and criticality analysis.
    • Collaborate with Cell & Gene Therapy Drug Substance Development and Quality organizations to establish and maintain the control of the process.
    • Accountable for DS process FMEA authoring and revision through drug substance life cycle.
    • Leverage MSAT team’s technical knowledge and expertise to lead investigations from initial analysis, root cause determination to establishment and execution of effective CAPAs.
    • Provide on-the floor support during engineering and GMP DS manufacturing batches. Prevent and resolve issues taking place during production through use of process analytical technologies and product monitoring.

    Qualifications

    • Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 10+ years’ experience, MS with 13+ years, BS with 16+ years
    • Proven experience with equipment and manufacturing processes commonly used for allogeneic & autologous cell therapies and cell culture derived viral vectors.
    • Robust experience in technology transfer from development into a cGMP Manufacturing.
    • Direct experience of working in quality systems, authoring and review of GMP and technical documents.
    • Previous experience in facility commissioning, equipment qualification and maintenance is highly preferred.
    • Thorough understanding of GMP requirements and their relation to process operations.
    • Demonstrated project management capabilities.
    • Self-motivated with strong interpersonal and organizational skills.
    • Emotional intelligence to communicate and interact internally and with clients to drive program deliverables.

Associate Director/Director, Drug Substance, MSAT

King of Prussia, PA, US
Apply Now >