# Senior Scientist, Viral Vector Process Development, Upstream

**Company**: Viral Vector and New Modalities Cell Therapy Operations
**Location**: Gaithersburg, Maryland, United States of America
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Salary**: $108,473.60 - $162,710.40
**Category**: Engineering
**Industry**: Healthcare

**Apply**: https://astrazeneca.eightfold.ai/careers/job/563877689868523
**Canonical**: https://yubhub.co/jobs/job_4ee3aa8d-ab3

## Description

We are looking for a highly motivated and experienced Senior Scientist, Viral Vector Process Development (Upstream) to join our team. As a key member of our Cell Therapy modalities portfolio, you will play a critical role in building and leading a high-performing team that accelerates AstraZeneca's emerging Cell Therapy modalities portfolio.

Your primary focus will be on designing, executing, and optimizing upstream Lentiviral Vector (LVV) processes with a primary focus on suspension bioreactor platforms at clinical and commercial scales. You will contribute hands-on to experimental design, process characterization, and scale-up/tech transfer activities from research through IND enabling, partnering closely with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs.

Key Responsibilities:

- Plan and perform experiments to develop and optimize LVV upstream processes for suspension cell culture (transient or stable producer cell systems), targeting improvements in titer, quality, robustness, and cost.

- Execute unit operations across seed, production, and harvest interfaces; support scale-up strategies from bench to pilot and clinical scales; develop and use scale-down models for characterization and comparability.

- Design DOE studies, identify CPPs/CMAs, analyze data, and propose control strategies; document results in protocols and reports; maintain fit for-purpose knowledge records.

- Contribute to definition of design space, in-process controls, and operating ranges; trend process performance and drive troubleshooting, root cause analysis, and corrective actions.

- Prepare technical transfer packages and support transfers to internal GMP sites and CDMOs; align process documentation with cGMP principles for late-stage readiness.

- Work closely with Analytical Development on assay readiness and in process testing; partner with Manufacturing, Supply, and Quality to ensure operational feasibility and compliance.

- Apply Lean practices and digital tools for scheduling, data integrity, and reproducibility; track KPIs (titer, infectivity, impurity profiles, cycle time, right first time) and recommend improvements.

Qualifications:

- Education: Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands-on industry experience.

- Experience: Hand-on experience developing suspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations, process characterization, and technology transfer.

- Technical Skills: Proficiency in suspension cell culture, transfection/infection strategies, media/feed optimization, single-use rocking-platform and stirred-tank bioreactors, and upstream-harvest interfaces; working knowledge of statistical DOE and data analytics tools.

- GMP Readiness: Experience supporting cGMP interfaces (documentation, change control, sampling plans) and contributing to CMC sections or technical responses is a plus.

- Communication & Teamwork: Strong written and verbal communication skills; ability to work effectively in cross-functional, matrixed teams; demonstrated problemsolving and troubleshooting capability.

- Tools & Automation: Experience with single-use systems, process automation/PAT, and digital lab systems (ELN/LIMS) preferred.

Preferred Qualifications:

- Demonstrated success scaling suspension LVV processes to pilot/clinical scales and sustaining performance via monitoring and continuous improvement.

- Experience linking upstream parameters to analytical outcomes (titer, infectivity/potency, residuals/impurities) to guide process decisions.

- Contributions to regulatory filings (data tables, process descriptions) and participation in tech transfer to CDMOs or internal GMP sites.

- Experience implementing Lean/continuous improvement and robust documentation/knowledge management in PD labs.

## Skills

### Required
- viral vector process development
- upstream process development
- Lentiviral Vector (LVV)
- suspension bioreactor platforms
- experimental design
- process characterization
- scale-up/tech transfer
- Research
- Analytical Development
- CMC
- Regulatory
- Manufacturing
- Quality
- external CDMOs
- Lean practices
- digital tools
- scheduling
- data integrity
- reproducibility
- KPIs
- titer
- infectivity
- impurity profiles
- cycle time
- right first time

### Nice to have
- single-use systems
- process automation/PAT
- digital lab systems (ELN/LIMS)
- statistical DOE
- data analytics tools
- cGMP interfaces
- change control
- sampling plans
- CMC sections
- technical responses
- Lean/continuous improvement
- robust documentation/knowledge management