Associate Principal Scientist, Viral Vector Downstream Process Development

AstraZeneca plc; Gaithersburg (MD); On-site; USD 142,000 - 213,000; Full time

Job summary

AstraZeneca plc in Gaithersburg, MD seeks an Associate Principal Scientist to lead LVV downstream process development, driving purification strategy from early development to clinical and commercial readiness.

The role requires leading cross-functional teams, advancing DOE/QbD initiatives, and ensuring cGMP compliance, with emphasis on scale-up and technology transfer to internal GMP sites and CDMOs.

Qualifications

• M.S. with 10+ years of hands-on industry experience in downstream process development.
• Ph.D. with 7+ years of hands-on industry experience in downstream process development.
• Extensive, hands-on LVV downstream process development or related viral vectors/biologics.
• Deep expertise in clarification, chromatography, UF/DF (TFF), and sterile filtration.
• Strong understanding of viral vector impurity profiles (HCP, host DNA) and mitigation.
• Experience supporting clinical and/or commercial scale processes including tech transfer.
• Knowledge of cGMP, Quality Systems, and FDA/EMA guidance for gene/cell therapies.
• Experience contributing to CMC sections of regulatory filings.
• Advanced statistics, DOE, and multivariate data interpretation.
• Strong application of QbD, risk management, and process justification.
• Excellent written and verbal communication; matrix leadership.

Responsibilities

• Define, develop, and execute LVV downstream purification strategies for IND-enabling to commercial manufacturing.
• Provide scientific leadership across clarification, chromatography, UF/DF, and sterile filtration.
• Lead cross-functional matrixed teams; align on strategy, timelines, and decisions.
• Coach scientists and engineers for downstream development activities.
• Design and qualify scale-down models; support scale-up to pilot and commercial equipment.
• Author and review technology transfer packages; enable successful CDMO transfer.
• Contribute to CMC strategies, control strategy, and in-process monitoring.
• Drive DOE, QbD, risk assessments, and root-cause investigations.
• Identify and evaluate new purification technologies and continuous improvement.
• Ensure compliance with cGMP, data integrity, and Quality Systems.

Skills

LVV downstream process development

Clarification

Chromatography

UF/DF (TFF)

Sterile filtration

DOE-based investigations

QbD principles

Risk assessments (FMEA)

Root cause investigations

Scientific leadership

Matrix leadership

Communication skills

Education

M.S. with 10+ years hands-on downstream experience

Ph.D. with 7+ years hands-on downstream experience

Job description

AstraZeneca is seeking a highly motivated and experienced Associate Principal Scientist in Viral Vector Downstream Process Development to support and expand our growing Cell Therapy and Gene Therapy portfolio. This role will play a critical leadership position in establishing robust, scalable, and phase‑appropriate lentiviral vector (LVV) downstream purification processes from early development through clinical and commercial readiness.

The successful candidate will lead matrixed project teams, act as a technical authority for LVV downstream purification, and partner closely with cross‑functional stakeholders including Research, Upstream PD, Analytical Development, CMC, Manufacturing, Quality, Regulatory, and external CDMOs.

Key Responsibilities

Downstream Process Development & Strategy

• Define, develop, and execute end‑to‑end LVV downstream purification strategies for ex vivo and in vivo applications with focus on yield, purity, potency, consistency, scalability, and cost.
• Establish platform‑aligned, phase‑appropriate purification processes suitable for IND‑enabling, clinical, and commercial manufacturing.
• Provide scientific leadership and technical oversight across clarification, chromatography, UF/DF (TFF), and sterile filtration operations.

Matrix Leadership & Project Execution

• Lead and influence cross‑functional, matrixed project teams, driving alignment on technical strategy, timelines, and decision‑making.
• Coach and guide scientists and engineers for the execution of downstream development activities.
• Ensure high‑quality experimental design, execution, data interpretation, and timely communication of results.

Scale‑Down Models, Scale‑Up & Technology Transfer

• Design and qualify representative scale‑down models to support process characterization and comparability.
• Support scale‑up to pilot, clinical, and commercial‑relevant equipment and consumables.
• Author, review, and approve technology transfer packages, and support successful implementation at internal GMP sites and external CDMOs.

CMC & Regulatory Enablement

• Contribute to and shape CMC downstream development strategies, including control strategy, in‑process monitoring, and operating ranges.
• Author and review CMC‑relevant documentation (development reports, batch records, process descriptions).
• Support preparation of regulatory submissions (e.g., IND).

Process Characterization, QbD & Risk Management

• Lead process characterization and platform studies, including DOE‑based investigations.
• Apply QbD principles, risk assessments (e.g., FMEA), and scientific justification to define design space and control strategy.
• Drive root cause investigations, troubleshooting, and continuous improvement initiatives.

Innovation & Continuous Improvement

• Identify and evaluate novel and next‑generation purification technologies (e.g., advanced chromatography, membranes, PAT/digital tools).
• Champion platform evolution, efficiency gains, and robustness improvements aligned with long‑term modality strategy.

Documentation, Compliance & Quality

• Ensure development activities adhere to cGMP concepts, data integrity, and Quality Systems expectations.
• Author and review protocols, reports, development summaries, and technical documents at a high standard of scientific and regulatory quality.
• Interface closely with Quality to ensure inspection readiness and compliance.

Minimum Qualifications

Education

• M.S. with 10+ years, or Ph.D. with 7+ years of hands‑on industry experience in downstream process development.

Technical & Industry Experience

• Extensive, hands‑on experience in LVV downstream process development (strongly preferred) or other viral vectors/biologics.
• Deep expertise in clarification, chromatography, UF/DF (TFF), and sterile filtration.
• Strong understanding of viral vector‑specific impurity profiles (HCP, host cell DNA, process residuals) and mitigation strategies.
• Experience supporting clinical and/or commercial scale processes, including tech transfer.

CMC, GMP & Regulatory

• Proven working knowledge of cGMP principles, Quality Systems, and relevant FDA/EMA guidance for gene and cell therapies.
• Direct experience contributing to CMC sections of regulatory filings.

Data, Statistics & Risk Tools

• Advanced experience with statistical analysis, DOE, and multivariate data interpretation.
• Strong application of QbD, risk management, and process justification methodologies.

Leadership & Collaboration

• Excellent written and verbal communication skills.
• Demonstrated ability to lead in matrixed environments, influence stakeholders, and resolve complex technical challenges.

Preferred Qualifications

• Track record of scaling LVV or viral vector purification processes from preclinical through clinical and commercial‑relevant equipment.
• Experience supporting technology transfer to GMP manufacturing sites and CDMOs.
• Exposure to PAT, digital tools, and data/knowledge management systems.
• Demonstrated success in building and delivering next‑generation purification processes end‑to‑end.

The annual base pay for this position ranges from $142,377.60 - $213,566.40. 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. Benefits offered included 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, employee will be in an “at‑will position” and the Company reserves the right to modify base pay (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

28-Sep-2026

Closing Date

11-Oct-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.