Process Development Jobs in Frederick, MD (NOW HIRING)

AstraZeneca is looking for a highly motivated, experienced and strategic AssociateDirector, Viral Vector Process Development (Upstream). This role will be a key part of ahigh-performing function that accelerates AstraZeneca's emerging Cell Therapymodalities portfolio. The role will lead end-to-end upstream design, development, andscale-up of Lentiviral Vector (LVV) manufacturing processes, with a primary focus onsuspension bioreactor platforms at clinical and commercial scales. This leader will leadupstream process development strategy and execution from research through IND enabling and into late-stage readiness. The role operates in a highly collaborative,matrixed environment. The ideal candidate combines deep viral vector expertise withoperational excellence and cross-functional leadership. This position is based in Gaithersburg, MD.

Key Responsibilities

• Upstream Lead on Suspension Platforms: Lead platform and product specific LVVupstream processes optimized for suspension cell culture (e.g., stable producer ortransient systems); drive innovations to improve titer, quality, robustness, and cost atpilot, clinical, and commercial scales.

• Scale-Up, Scale-Down, and Tech Transfer: Design scale-up strategies from bench to50-200 L single-use bioreactors; establish representative scale-down models forcharacterization and comparability; lead phase-appropriate validation andtechnology transfer to internal GMP sites and CDMOs.

• Experimental Design & Characterization: Oversee design, planning, and executionof upstream studies; identify CPPs/CMAs and establish design space usingstatistical DOE, MVDA, and PAT; implement and maintain a fit-for-purposeknowledge management system capturing process history, lessons learned, andcontrol strategies.

• Team Leadership: Provide mentoring, training, and technical guidance to the otherjunior team members; promote a culture of safety, scientific rigor, and continuousimprovement.

• Documentation & Compliance: Ensure generation of high-quality technicaldocumentation (protocols, characterization reports, validation summaries, techtransfer packages, and regulatory CMC sections); implement fit-for-purpose systemsand business processes aligned with corporate guidelines and cGMP principles forlate-stage readiness.

• Operational Excellence: Perform process performance trending, root cause analysis,and corrective/preventive actions; establish and track KPIs (titer, infectivity, impurityprofiles, cycle time, right-first-time); deploy Lean and digital tools for scheduling, dataintegrity, and reproducibility.

• Stakeholder & Vendor Management: Collaborate with internal partners and externalsuppliers/CDMOs; support sourcing and qualification of single-use suspensionbioreactors, mixing systems, and critical raw materials (media, feeds, plasmids).

Qualifications

• Education: Advanced degree (PhD) in Biochemical Engineering, Virology,

• Chemical/Biomedical Engineering, Biotechnology, or related field with 6+ years ofrelevant experience; or MS with 10+ years.

• Experience

• Deep expertise in upstream LVV process development on suspension platforms,including scale translation to clinical/commercial, process characterization, andtechnology transfer; proven track record advancing programs from research throughIND enabling and into late-stage/GMP settings.

• Technical Skills: Mastery of upstream unit operations for LVV in suspension (cellsubstrate selection and adaptation, transfection/infection strategies, media/feedoptimization, bioreactor control, harvest/clarification interfaces) and application ofstatistical DOE and data analytics.

• GMP Readiness: Practical experience with cGMP manufacturing operations, phaseappropriate validation, and contributing to regulatory filings for US and ex-USmarkets.

• Leadership & Communication: Ability to lead teams, influence in a matrix

• environment, and communicate complex technical concepts to diverse stakeholders;strong troubleshooting and problem-solving skills.

• Tools & Automation: Experience with single-use suspension bioreactors, processautomation, PAT, and digital lab systems to accelerate development and ensurereproducibility.

Preferred Qualifications

• Clinical/Commercial Scale Delivery: Demonstrated success scaling suspension-based LVV processes to clinical and commercial production with sustainedperformance and continuous improvement.

• Analytical Interface: Familiarity with upstream-analytical linkages (titer,infectivity/potency, residuals/impurities) to guide process decisions andspecifications; experience defining process controls for suspension systems.

• Regulatory Contributions: Experience preparing process/manufacturing sections ofregulatory submissions and participating in health authority interactions for LVVprograms.

• Operational Excellence: Track record implementing Lean practices and robustdocumentation/knowledge management in PD settings.

The annual base pay for this position ranges from $138,392.80 - $207,589.20. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

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.