Principal Engineer, Biologics Drug Substance Technology Transfer

This is what you will do:

The position will lead technical transfer of early and late clinical phase drug substance, to both internal and external contract development & manufacturing (CDMO) companies. This position will provide strong scientific leadership, mentorship and subject matter expertise for all aspects of drug substance including technology transfer, process fit analysis, process modelling, raw material controls and aseptic process assurance/microbiological control. The Principal Engineer will also lead timely risk identification, communication and resolution and work in close collaboration with Process Development and Clinical Supply (PDCS), non-GMP internal Pilot network, Alexion Operations, Quality (QA), Regulatory (RA), Analytical Development Quality Control (ADQC) and internal and external Manufacturing sites.

Other areas of responsibility include technical support for ongoing clinical manufacturing, process troubleshooting to manufacturing activities such as supporting process related investigations, deviation resolution, corrective actions/preventative actions, and direct responsibility for process monitoring/control charting of manufacturing operations. Review of technical documents and support for regulatory submissions (IND/IMPD, BLA/MAA) are other responsibilities.

You will be responsible for:

• Manage and lead clinical technical transfer process and ensure alignment with CMC schedule to meet program and company goals / metrics, as required. This includes continuous communication with Quality Assurance, Quality Control, Upstream and Downstream Process Development, Drug Product Development, Analytical Sciences and Supply Chain teams to ensure efficient tech transfer of Alexion's clinical drug substance manufacturing activities.
• Provide technical leadership and oversight for internal and external technology transfers, and process development, where required
• Lead technical evaluation and contribute to selection of external manufacturing facilities for drug substance
• 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 partnering 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
• Identify issues and risks and lead cross functional team to identify and drive alignment on action/mitigation plan for path forward
• 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
• Foster collaboration of all cross-function and external partners
• Manage and develop matrix team providing opportunities and actively supporting career enhancement and growth
• Co-author and review IND/IMPD, BLA/MAA and other technical documents for regulatory agency submissions
• Global role requiring domestic and international travel (up to ~20%)

You will need to have:

• PhD in biochemistry, biological science, or chemical engineering or related fields with 6+ years of relevant experience, or BS/MS with 10+years of relevant experience in biopharmaceutical organization with expertise in drug substance development and/or tech transfer
• Passport and ability to travel domestically and internationally for manufacturing site support
• 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. Intellectual capabilities include engaging in problem solving and non-linear thought, analysis, and dialogue, collaboration with other peer functional representatives.
• Technical services experience for discrepancy resolution, CAPA implementation and process data monitoring for internal and external facilities
• Upstream or downstream manufacturing of monoclonal antibodies/therapeutic proteins with lab and pilot plant operations (non-GMP/GMP)
• Demonstrated Understanding of technology transfer, process fit analysis and clinical phase appropri