Location: Gaithersburg, MD (USA) | Hybrid: Three days per week on-site
Key accountabilities
- Platform strategy and standards: Set the platform vision, engineering standards, and multi‑year roadmap. Define process engineering operating envelopes (highs/lows, CPPs, equipment specifications, control strategies) with a clear engineering design basis. Publish reusable engineering templates and playbooks including platform process descriptions, P&ID standards, equipment specifications, utility requirements, tech transfer guides, and manufacturing technology standards.
- Facility integration: Establish design principles for process–facility interfaces (cleanroom classifications, HVAC requirements, utility capacities, material flow, equipment layouts) that enable platform technologies. Build comparability and “switch” strategies into platforms and facility designs to manage lifecycle changes with minimal disruption.
- Manufacturing and process leadership: Set enterprise standards and adoption plans for end‑to‑end processing, including facility design requirements and utility infrastructure. Define PAT/APC strategies, RTD models, steady‑state verification, equipment‑train configurations, and start‑up/shutdown procedures aligned to global regulatory expectations and engineering best practice.
- Scale‑up and execution: Guide piloting through commercial implementation with sound scale‑up principles, equipment sizing, facility fit studies, and utility demand modeling. Quantify value, capture learnings, and embed them across the network.
- Facility readiness: Assess existing capabilities versus platform requirements; define retrofit strategies or greenfield specifications to enable deployment.
- Collaboration and governance: Co‑create with CMC, Clinical, Regulatory, QA, Facilities Engineering, Project Engineering, and site leaders on process risk, equipment selection, facility design, and lifecycle strategies. Harmonize engineering practices and facility design standards across internal sites, CMOs, and acquisitions with clear governance, roles, and accountability. Maintain transparent communication, timely updates, and risk escalation across Global Tech Ops and Biologics leadership.
- Technology and site enablement: Lead site technology transfers, facility‑fit assessments, utility definition, equipment installation and qualification protocols, and adoption of digital monitoring/decision tools. Where required, stand up process engineering capabilities (mass/energy balance modeling, equipment sizing methodologies, scale‑up principles, process simulation).
- Building systems integration: Define requirements for HVAC, clean utilities, waste treatment, and automation infrastructure to support flexible manufacturing.
- Regulatory partnership: Co‑author technical content for design control strategies, including process engineering rationale and facility design justification to enable post‑approval flexibility. Prepare teams and sites for regulatory interactions and inspections with emphasis on process design rationale and facility compliance.
- Data‑driven improvement: Establish standards for process data, equipment performance metrics, utility consumption tracking, and information needed for autonomous decision‑making and engineering analysis. Define engineering KPIs and scorecards (e.g., equipment utilization, process capability indices, facility efficiency metrics) and run feedback loops to track adoption and impact.
Modalities in scope
- Core: Fed‑batch and intensified mammalian bioprocessing, microbial fermentation
- Emerging: Nucleic acid therapies, antibody–drug conjugates, radioconjugates, viral and gene therapies, enzyme‑produced biologics, protozoan fermentation
Qualifications
- Experience: 13+ years in biologics manufacturing with strong process engineering and/or facilities engineering background (or 10+ years with an advanced degree in Chemical Engineering, Mechanical Engineering, or related field)
- 7+ years in Process Engineering/Development with facility design exposure; late‑stage and commercial Pharma experience.
- Engineering expertise: Demonstrated experience in process scale‑up, equipment specification and selection, P&ID development, mass/energy balance calculations, and facility design for biologics manufacturing.
- Intensified manufacturing: Recent, hands‑on leadership implementing n‑1 or n‑1 perfusion and/or producing high‑yield biologics with connected or continuous downstream in GMP manufacturing, with emphasis on process engineering and facility integration.
- Facility engineering: Experience with cleanroom design, utility systems (WFI, clean steam, HVAC), material flow optimization, and equipment layout for GMP.
- Regulatory: Proven authoring of technical sections and/or leading technical regulatory strategy focused on process design and engineering controls.
- Collaboration: Strong record of leading matrix teams and influencing across process development, facilities engineering, project engineering, and external partners/CMOs. Site engineering leadership background; validation experience for new modalities/formulations with facility commissioning and qualification.
- Late‑phase nucleic acid manufacturing or analytics experience.
- Experience with process simulation tools (e.g., SuperPro Designer, Aspen).
- Proficiency with Power BI, Power Automate, AutoCAD/Revit, and Microsoft 365.
What success looks like
- Engineering standardization and speed: Reusable platform standards (P&IDs, equipment specs, facility templates) that shorten development, facility design, and tech transfer timelines.
- Process–facility integration: Seamless alignment of process requirements with facility capabilities enabling rapid platform deployment.
- Automation and innovation leverage: Scaled manufacturing with optimized footprint delivering robustness, cost, sustainability, and space‑utilization gains.
- Network alignment: Consistent engineering practices and facility design standards across sites and CMOs with clear governance.
- Operational outcomes: Higher yields, lower variability, optimized facility utilization, reduced utility consumption, and faster time to clinical and commercial supply.
Reporting line and scope
- Reports to: Senior Director/VP within Global Tech Ops (Biologics)
- Teaming model: Leads cross‑functional, matrixed teams; may directly manage a small group of platform and process engineers; influences network‑wide engineering community of practice.
- Hybrid: Three days per week on-site in Gaithersburg, MD; two days remote, aligned to site norms
- Travel: Approximately 20–30% to development centers, manufacturing sites, and CMOs
Why AstraZeneca Join a science‑led, patient‑focused organization shaping the future of biomanufacturing. You will have enterprise reach, the mandate to harmonize standards, and the opportunity to deploy innovative platforms that accelerate medicines to patients. Equal opportunity statement AstraZeneca is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.Compensation and benefits (Gaithersburg, MD) The annual base pay for this position ranges from $175,498 to $263,247 Annual USD. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, the employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
30-Mar-2026
Closing Date
28-May-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.