Downstream Process Tech Transfer Lead

AstraZeneca has an opening for a DSP TT Lead in Gaithersburg, MD. We are seeking a highly motivated downstream technology transfer (TT) and manufacturing support professional. This position will manage a team responsible for transfer of downstream processes from development into clinical and commercial manufacturing. The position resides within the Purification Process Sciences (PPS) department (within Research and Development). Members of the TT group within this department work closely with the process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial processes to manufacturing production.


RESPONSIBILITIES:
• ROUTINELY TRANSFER PROJECTS AS DOWNSTREAM TECH TRANSFER REPRESENTATIVE INCLUDING FIT-TO-PLANT, PROCESS RISK ANALYSIS, TIMELY GENERATION OF TT DOCUMENTATION, BATCH RECORD REVIEW/APPROVAL, MANAGING TECHNICAL RELATIONSHIP BETWEEN SENDING AND RECEIVING ORGANIZATIONS, CAMPAIGN MONITORING AND SUPPORT, PERFORMANCE ANALYSIS AND INTERPRETATION, INVESTIGATION SUPPORT, AND CAMPAIGN SUMMARY REPORT AUTHORING
• MANAGE LAB-SCALE EXPERIMENTS TO SUPPORT PROCESS CHANGES, GENERATE ROBUSTNESS DATA, AND/OR RESOLVE MANUFACTURING NON-CONFORMANCES
• PROACTIVELY INFLUENCE PROCESS DECISIONS TO HELP AVOID NON-CONFORMANCES
• PROVIDE INPUT ON PROCESS DEVELOPMENT AND MANUFACTURING STRATEGIES
• AUTHOR/REVIEW TECHNICAL REPORTS AND DELIVER PRESENTATIONS UTILIZING SOUND SCIENTIFIC REASONING AND INTERPRETATION OF THE AVAILABLE DATA
• AUTHOR/REVIEW IND/BLA SECTIONS AND RESPONSES TO QUESTIONS TO SUPPORT REGULATORY FILINGS
• BUILDS AND MAINTAINS RELATIONSHIPS WITH PARTNERS, COLLABORATORS, DEPARTMENTS AND CONTRACTORS.
• CONTRIBUTE TO THE IMPROVEMENT OF THE TT BUSINESS PROCESSES THROUGH IDEA GENERATION, TEAM LEADERSHIP, AND IMPLEMENTATION

REQUIRED SKILLS:
• Downstream TT and process development experience
• Comprehensive knowledge of chromatography columns, virus and sterilizing-grade filters, and TFF membranes (bench, pilot and production scale)
• Fundamental understanding of downstream unit operations such as affinity, ion exchange, and hydrophobic interaction chromatography, low pH and surfactant-based viral inactivation, virus filtration, and UF/DF
• Working knowledge of scale-up/scale-down principles
• Broad understanding of CMC activities and responsibilities with respect to TT
• Experience as people manager in matrix team environments, ability to work with various subject matter experts and drive successful completion of team goals
• Knowledge of GMP manufacturing principles and documentation
• Demonstrated critical thinking skills
• Excellent written and verbal communication skills
• Demonstrated ability to outline issues, assess and present risks/benefits, and ability to make recommendations with limited data using sound scientific reasoning
• Skilled in effectively explaining complex scientific or engineering concepts to a broad