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 appropriate process oversight and control, with expertise in late phase technology transfer and validation
• cGMP/ICH requirements for clinical and commercial biopharmaceuticals
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections
• Ability to influence others without authority, including external partners, and communicate with all levels of the organization
• Strong project leadership and resource management skills along with good verbal and interpersonal skills
• Ability to support development of bold but achievable project plans to ensure effective, timely execution!

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
• Expertise in CFD modeling, raw material or microbiological control strategy
• Capability to analyze data using basic statistical methods, and present comparability analysis in evidence of effective transfer
• Knowledge of quality attribute measurement assays and application to troubleshooting product quality related discrepancies.

Expectation of working in the office 4 days a week statement: 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!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.