Senior Engineer, Biologics Drug Substance Technology Transfer

This is what you will do:

The primary responsibility of this position will be to support Drug Substance Technology Transfers within the biologics therapeutic pipeline for Alexion, Rare Disease Business Unit of Astra Zeneca. Transfer activities will be in support of CMC development of early/late phase and commercialization of biologics therapeutics. Considered a technical subject matter expert (SME) supporting all aspects of technical transfer, GMP manufacture, and process validation in 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!

Serve as a technical lead assuring planning and completion of all technical documents for knowledge transfer, supporting manufacturing, and process validation activities (batch records, operating procedures, technical transfer and process validation master plans and associated protocols and reports). Monitor, track, and trend process performance and process validation execution and data and lead timely risk identification, communication and resolution. The successful candidate will also routinely work with Process Development, manufacturing, and other partners to resolve manufacturing issues and recommend corrective actions or process improvements. This work will include direct interaction with internal and external manufacturing partners. Support continuous improvement for efficiency of Technology Transfer plans and work processes.

You will be responsible for:

• Lead Technology Transfer and/or process validation of Drug Substance (DS) manufacturing processes to internal and external GMP manufacturing network for Alexion’s biologics pipeline, covering early phase, late phase and process validation.
• Lead the development, implementation and execution of Technology Transfer and process validation master plans and support the transition of technical leadership for validated processes to Alexion Operations.
• Lead efforts to assess readiness for early and/or late phase transfers using appropriate tools and manage risk communication with leadership to communicate 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.
• Lead sample coordination and planning for manufacturing campaigns, responsible for communicating sample plans to manufacturing sites, and collaborate with internal/external partners for effective sample management
• Ensure technical transfers are implemented appropriately in terms of equipment, materials and evaluate impact on manufacturing process due to changes in equipment, scale, and raw materials.
• Provide manufacturing floor technical support for solving and general technical guidance of ongoing manufacturing campaigns. Lead the technical decision making during initial manufacturing campaigns and partner with manufacturing site, Process Development, QA, and relevant stake-holders to ensure tactical objectives are met.
• Ensure the compilation of data for regulatory source documents. Review IND/IMPD, BLA/MAA and other technical documents for regulatory agency submissions. Serve as an authority on Technology Transfer and process validation during regulatory agency inspections.
• Ensures open communication and effective collaboration of all involved functions and external partners.
• Lead frequent technical discussions within and between functional areas through informal and formal presentations
• Drive continuous improvement of efficiency of Technology Transfer plans and work processes
• This role includes domestic and international travel~up to ~25%

You will need to have:

• PhD or MS with 5 years biotechnology/pharmaceutical industry or BS with 8 years of proven experience
• Experience and in-depth technical and operational knowledge of multiple Drug Substance unit operations (i.e., cell culture, centrifugation, chromatography, filtration, and UF/DF).
• Understanding of GMP requirements for clinical or commercial biopharmaceutical manufacturing and the ability to implement standard methodologies to ensure manufacturing operations are GMP compliant.
• This role is primarily office based. Passport and ability to travel domestically and Internationally up to two weeks at a time for manufacturing site support.
• Work towards results independently while being agile with evolving priorities
• Effective problem solving and technical decision making skills in a manufacturing environment.
• Strong oral and written communication skills and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners.
• Strong collaboration skills, with ability to participate in global multi-functional teams and work effectively on a highly matrix team!

We would prefer for you to have:

• Knowledge and expertise in late phase manufacturing and process validation
• Prior experience in collaborating with contract manufacturing companies
• Experience with supporting regulatory submissions and regulatory agency inspections
• Proven track record supporting or leading continuous improvement initiatives
• Knowledge and use of basic statistical analysis methods

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 requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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.