Associate Director, Biologics Production

AstraZeneca • Gaithersburg, MD

122d • $134,892 - $202,339

About The Position

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.

Requirements

• Ph.D. in Biochemistry, Bio/Chemical Engineering, or related field.
• 3–6+ 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 purification for complex formats.
• Hands‑on with ÄKTA systems (method development + operations), HPLC/UPLC, CE‑SDS, and related analytics.
• Proven experience deploying liquid handling platforms (e.g., Hamilton) and robotics orchestration (e.g., Green Button Go® Scheduler); familiarity with scheduler logic, error handling, and lab integration.
• Working knowledge of Genedata Biologics, ELN and strong data integrity instincts.
• Track record building platform workflows, raising throughput, and shortening DNA‑to‑material lead times via automation and process rigor.
• Excellent stakeholder management and project leadership across matrixed discovery teams; clear, concise scientific communication.

Nice To Haves

• Exposure to mixed‑mode/novel resin strategies for mispair control; rapid capture (e.g., Fibro media) and clarification innovations.
• Basic scripting or data skills (e.g., Python/R) and comfort with APIs/integration concepts; experience with additional schedulers/LIMS a plus.
• Experience with externalization models and CRO/CMO coordination for elastic capacity.

Responsibilities

• 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.
• Spearhead high‑throughput operations using integrated automation and orchestration.
• Utilize liquid handling systems such as Hamilton (e.g., Microlab STAR/Vantage) for upstream sample prep, titrations, and parallel mini‑purifications.
• Manage robotics scheduling/orchestration using Green Button Go Scheduler or similar systems to coordinate liquid handlers, incubators, plate readers, and chromatography queues.
• Ensure 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 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.
• 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, ensuring materials are fit for decision‑making in discovery and lead optimization.
• Establish robust troubleshooting playbooks to keep delivery on track.
• 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.
• 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.

Benefits

• 401(k) plan
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees