Upstream Process Tech Transfer Lead

Astra Zeneca has an opening for a USP TT Lead (position based out of Gaithersburg MD in US, or Cambridge, UK but would work remotely from current location). We are seeking a highly motivated and experienced upstream tech transfer and manufacturing support professional. This position will be responsible for transfer of upstream processes from development into clinical/commercial manufacturing at CMOs. The position resides within the Cell Culture and Fermentation Sciences (CCFS) department (within Research and Development). Members of the tech transfer function within this department work closely with the process development scientists (located in the US and UK), Operations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial processes to manufacturing production.


RESPONSIBILITIES:
• TRANSFER AND SUPPORT ASSIGNED PROJECT(S) TO CMO(S) AS UPSTREAM TECH TRANSFER REPRESENTATIVE INCLUDING FIT-TO-PLANT, PROCESS RISK ANALYSIS, TIMELY GENERATION OF TECH TRANSFER DOCUMENTATION, BATCH RECORD REVIEW/APPROVAL, MANAGING TECHNICAL RELATIONSHIP BETWEEN SENDING AND RECEIVING ORGANIZATIONS, CAMPAIGN MONITORING AND SUPPORT, PERFORMANCE ANALYSIS AND INTERPRETATION, INVESTIGATION SUPPORT AND DEVIATION WRITE UPS, PROCESS VALIDATION DOCUMENTATION REVIEW/APPROVAL, CAMPAIGN SUMMARY REPORT AUTHORING, AND ROUTINE PRESENTATIONS TO CROSS-FUNCTIONAL TEAMS AND MANAGEMENT
• BUILDS AND MAINTAINS RELATIONSHIPS WITH PARTNER GROUPS
• PROACTIVELY ADDRESSES RISKS/ISSUES AND INFLUENCE PARTNERS/CMOS TO AVOID NON-CONFORMANCES AND ENABLE EFFICIENT TRANSFERS
• REPRESENT FUNCTION ON CROSS-FUNCTIONAL TEAMS
• PARTICIPATE IN DESIGN OR ANALYSIS OF LAB-SCALE EXPERIMENTS TO SUPPORT PROCESS CHANGES, GENERATE ROBUSTNESS DATA, AND/OR RESOLVE MANUFACTURING NON-CONFORMANCES
• WRITE TECHNICAL ASSESSMENTS AND/OR REPORTS AND DELIVER PRESENTATIONS

REQUIRED SKILLS:
• HANDS ON CELL CULTURE EXPERIENCE WITH STIRRED TANK BIOREACTORS (STAINLESS OR SINGLE USE)
• CELL CULTURE TECH TRANSFER AND/OR DEVELOPMENT EXPERIENCE
• HANDS ON OR TECH TRANSFER EXPERIENCE TO AT LEAST 200L SCALE OR ABOVE
• FUNDAMENTAL UNDERSTANDING OF UPSTREAM UNIT OPERATIONS SUCH AS MIXING, BIOREACTOR, AND FILTRATION.
• WORKING KNOWLEDGE OF THE SCALE-UP/SCALE-DOWN PRINCIPLES OF CELL CULTURE OR FERMENTATION PROCESSES
• KNOWLEDGE OF GMP MANUFACTURING PRINCIPLES AND DOCUMENTATION
• SKILLED IN ROOT CAUSE ANALYSIS AND PROBLEM-SOLVING
• DEMONSTRATED CRITICAL THINKING SKILLS
• DEMONSTRATED TECHNICAL WRITING
• EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
• SOUND DECISION MAKING WITH LIMITED DATA AND GUIDANCE
• DEMONSTRATED ABILITY TO OUTLINE ISSUES, ASSESS AND PRESENT RISKS/BENEFITS, AND ABILITY TO MAKE RECOMMENDATIONS USING SOUND SCIENTIFIC REASONING
• SKILLED IN EFFECTIVELY EXPLAINING COMPLEX SCIENTIFIC OR ENGINEERING CONCEPTS TO A BROAD AND DIVERSE CROSS-FUNCTIONAL AUDIENCE.
• EXPERIENCE WITH BEING AN EFFECTIVE AND INFLUENTIAL CONTRIBUTOR AND LEADER TO PROJECTS GOVERNED BY MATRIX TEAMS
• ABILITY TO WORK IN A FAST PACED ENVIRONMENT
• DEMONSTRATED INITIATIVE AND DRIVE FOR RESULTS
• DEMONSTRATED ABILITY TO STAND IN THE FACE OF STRONG/HIGHER LEVEL OPPOSITION
• MUST BE ABLE TO WORK INDEPENDENTLY
• EXPERIENCE WITH DATA AND STATISTICAL ANALYSIS
• PROVEN EXPERIENCE IN PREPARING DETAILED AND THOROUGH TECHNICAL PROTOCOLS AND REPORTS
• KNOWLEDGE OF THE DRUG DEVELOPMENT PROCESS, GLOBAL REGULATIONS, PROCESS VALIDATION AND ICH GUIDELINES

DESIRABLE SKILLS:
• EXPERIENCE IN A CGMP-REGULATED ENVIRONMENT AND/OR LARGE-SCALE BIOPROCESSING LABORATORY
• VIRAL BASED PRODUCTION EXPERIENCE • PRIOR EXPERIENCE LEADING PROJECTS OUTSIDE OF AREA OF TECHNICAL EXPERTISE
• SKILLED IN CONDUCTING COMPLEX TRANSFER/PROCESS DEVELOPMENT/TECHNOLOGY DEVELOPMENT PROJECTS SUPERVISION THIS POSITION WILL NOT HAVE ANY DIRECT SUPERVISORY RESPONSIBILITIES.

EXPERIENCE
A Bachelors, Masters or PhD Degree in an engineering or scientific discipline with a focus in a process engineering field (e.g., chemical or biochemical engineering) is strongly preferred.
The candidate must have relevant industry related experience (BS 8+, MS 6+, PhD 6+ years). Position requires periodic weekend work and/or periodic late night work.
Position may require supporting sites in different time zones.
Position may require some travel to CMO or other sites (domestic and international).