Senior Engineer, Viral Vector Manufacturing Tech Transfer

This is what you will do:

The position will oversee and lead technical transfer of early and late clinical phase plasmid DNA, viral vector drug substance and drug product (and accompanying analytics), to both internal and external contract development & manufacturing  (CDMO) companies. This position is responsible for providing strong scientific leadership, mentorship for junior team members and subject matter expertise including technology transfer, process fit analysis, process modelling, raw material manufacturing and controls and aspectic process assurance/microbiological control.  The Senior Engineer will also lead timely risk identification, communication and resolution and work in close collaboration with Process Development and Clinical Supply (PDCS), Alexion Operations, Quality (QA), Regulatory (RA), Analytical Development Quality Control (ADQC) and internal and external Manufacturing sites.  

You will be responsible for:

• Provide technical leadership and oversight of clinical technical transfer process to internal and/or external manufacturers and ensure alignment with CMC schedule to meet program and corporate goals / metrics, as required.  This includes continuous communication with key cross-functional stakeholders to ensure efficient tech transfer of Alexion's clinical viral vector manufacturing activities.

• Lead technical evaluation and contribute to selection of external manufacturing facilities. 

• Perform facility fit analysis, process gap assessments, and establish operational control strategy for each new receiving site. Lead efforts to assess readiness for early and/or late phase transfers using appropriate tools and manage risk communication with leadership along with proposed mitigation/s

• Lead creation and/or technical review of batch records, process validation protocols, change controls, and deviations to support GMP manufacturing throughout lifecycle of biologics pipeline in partnership with QA and Alexion operations as applicable

• Ensure appropriate data management, perform process monitoring and communicate operation status to management.  Provide technical depth and lead OOT and deviation investigations as required

• Serve as Drug Substance Team Lead, including representation at CMC asset team, to support late-stage pipeline programs through validation campaigns and initial commercialization, as required. Ensures effective collaboration of all involved functions and external parties

• Lead continuous improvement of efficiency of technology transfer plans and work process and influence manufacturing sites to focus on improving efficiency of technology transfer processes

• Co-author and review IND/IMPD, BLA/MAA and other technical documents for regulatory agency submissions

• Global role requiring domestic and international travel (~20%)

You will need to have:

• PhD in biochemistry, biological science, or chemical engineering or related fields with 2+ years of relevant experience, or BS/MS with 8+years of relevant experience in biopharmaceutical organization with expertise in drug substance/drug product development and/or tech transfer

• This role is primarily office based.  During travel for manufacturing support, this role requires physical capabilities to gown and don PPE in GMP cleanroom environment and be present during manufacturing operations in a technical support role.  Physical elements include standing, climbing stairs, ladders, visual capability to read manufacturing control screens,  use a computer, engage in communications via phone, video, and electronic messaging.  Intellectual capabilities include engaging in problem solving and non-linear thought, analysis, and dialogue, collaboration with other peer functional representatives.

• Requires technical services experience for discrepancy resolution, CAPA implementation and process data monitoring for internal and external facilities

• Experience with upstream or downstream manufacturing of AAV viral vectors and/or plasmid DNA with lab and pilot plant operations (non-GMP/GMP)

• Requires strong understanding of technology transfer, process fit analysis and clinical phase appropriate process oversight and control, with expertise in late phase technology transfer and validation

• Comprehensive understanding of cGMP/ICH requirements for clinical and commercial biopharmaceuticals

• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections

• Strong project leadership and resource management skills along with good people, verbal, and communication skills. Ability to support development of aggressive but achievable project plans to ensure effective, timely execution and lead by influence both internal and external stakeholders.

We would prefer for you to have:

• Knowledge in planning for program advancement to process validation and commercial launch, with experience supporting teams through BLA approvals

• Strong knowledge of AAV-specific analytical methods and testing requirements

• Expertise in raw material or microbiological control strategy

• Capability to analyze data using basic statistical methods using tools such as JMP, and present comparability analysis in evidence of effective transfer

• Knowledge of quality attribute measurement assays and application to  troubleshooting product quality related discrepancies.

• Structured problem solving experience

In-person statement for 4 days in the office:
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.