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Associate Director, Biologics Production

AstraZeneca
Gaithersburg, United Statesfull_timeVerifiedPosted 4 Sept 2025
💰 $202,339/yr($134,893/yr$202,339/yr)

About the role

Multispecifics are redefining what’s possible in biologics. We’re building a high‑throughput, automation‑first production engine that delivers complex antibodies faster, at higher quality, and at scale, and we’re looking for a proven leader to take it to the next level. 

As Associate Director, Biologics Production (Expression & Purification), you will lead a team responsible for end‑to‑end expression and purification of multispecific antibodies and complex biologics (typically >100 mL lab scale, with pathways to multi‑liter). You’ll combine scientific depth with platform thinking, automation/robotics integration, and clear operational execution to compress DNA‑to‑data timelines for programs across AstraZeneca. 

What you’ll lead: 

Production & Process Development 

  • Own the sequence‑to‑material pipeline for multispecifics and complex biologics: transient transfection (primarily CHO), harvest/clarification, capture, polish, and QC‑ready delivery. 
  • Design and direct platform strategies that solve multispecific‑specific challenges (e.g., chain mispairing, aggregation control, avidity‑based separations). 
  • Build scalable purification flowsheets (Protein A/Fc alternatives, kappa/lambda selection, IEX/mixed‑mode, SEC) and drive DoE‑based optimization to lift yield, purity, and robustness. 
  • Closely align with Protein Engineering & Novel Modalities (PENM) on strategy, planning and prioritization to accelerate project delivery.  

Automation & Digital Transformation 

  • Spearhead high‑throughput operations using integrated automation and orchestration. 
  • Liquid handling systems such as Hamilton (e.g., Microlab STAR/Vantage) for upstream sample prep, titrations, and parallel mini‑purifications. 
  • Robotics scheduling/orchestration using Green Button Go Scheduler or similar systems to coordinate liquid handlers, incubators, plate readers, and chromatography queues. 
  • Seamless handoffs into chromatography (e.g., ÄKTA Pure/Avant; rapid cycles with Fibro PrismA) and analytical stations (SEC‑HPLC/UPLC, CE‑SDS). 
  • Champion digitalization by enforcing data integrity through Genedata Biologics and ELN, standardizing workflows and SOPs, and integrating telemetry and metrics (including lead times, yield, monomer percentage, and endotoxin levels) into real-time dashboards. 
  • Set up and optimize requesting systems and digital workflows to streamline operations and improve efficiency. 
  • Drive continuous cycle‑time reductions through automation scripts, method libraries, and scheduler templates; partner with Engineering/Automation to extend capabilities over time. 

Technical Leadership 

  • Provide deep bench‑to‑platform guidance across construct inputs (tags/geometries), culture conditions, clarification approaches, and purification schemes tailored to bispecifics, tri‑, and tetra‑specific formats. 
  • Elevate in‑process controls and release‑for‑use criteria in partnership with Analytics & Developability (e.g., SEC, CE‑SDS, HCP/endotoxin panels), ensuring materials are fit for decision‑making in discovery and lead optimization. 
  • Establish robust troubleshooting playbooks (e.g., mispair diagnostics, mixed‑mode polishing rescue, rapid re‑prep) to keep delivery on track. 

Team Development & Strategy 

  • Recruit, develop, and empower a high‑performing team of scientists and engineers; set objectives, coach careers, and nurture a culture of safety, quality, innovation, and continuous improvement. 
  • Define the 3–12 month roadmap for throughput, automation, and quality aligning capacity to portfolio demand and clarifying make‑vs‑buy triggers with preferred partners. 
  • Demonstrate Manager-in-Action behaviours as a role model; ensure proactive SHE ownership within the laboratories. 

Cross‑Functional Impact 

  • Serve as a strategic partner to Protein Engineering & Novel Modalities (PENM), Assays/Profiling & Pharmacology (APP), PS&A Analytics & Developability, Therapeutic Areas, and maintain close alignment with the Biologics Engineering organization in the UK.  
  • Collaborate with BPD Purification Process Sciences for scale‑up readiness and with senior leadership on budgets, resin strategies, consumables and instrumentation planning. 

Minimum Qualifications:  

  • Ph.D. in Biochemistry, Bio/Chemical Engineering, or related field. 
  • 8–10+ years in biologics production/purification within biotech/pharma, including leadership of teams delivering complex antibody modalities (multispecifics strongly preferred). 
  • Deep command of mammalian expression (transient CHO/HEK) and downstream purifi

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Company

AstraZeneca

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