Process Development Associate Jobs in Germantown, MD

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 phaseappropriate 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 crossfunctional stakeholders including Research, Upstream PD, Analytical Development, CMC, Manufacturing, Quality, Regulatory, and external CDMOs.

Key Responsibilities

Downstream Process Development & Strategy

• Define, develop, and execute endtoend LVV downstream purification strategies for ex vivo and in vivo applications with focus on yield, purity, potency, consistency, scalability, and cost.

• Establish platformaligned, phaseappropriate purification processes suitable for INDenabling, 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 crossfunctional, matrixed project teams, driving alignment on technical strategy, timelines, and decisionmaking.

• Coach and guide scientists and engineers for the execution of downstream development activities.

• Ensure highquality experimental design, execution, data interpretation, and timely communication of results.

ScaleDown Models, ScaleUp & Technology Transfer

• Design and qualify representative scaledown models to support process characterization and comparability.

• Support scaleup to pilot, clinical, and commercialrelevant 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, inprocess monitoring, and operating ranges.

• Author and review CMCrelevant 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 DOEbased 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 nextgeneration purification technologies (e.g., advanced chromatography, membranes, PAT/digital tools).

• Champion platform evolution, efficiency gains, and robustness improvements aligned with longterm 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.

Qualifications

Education

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

Technical & Industry Experience

• Extensive, handson 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 vectorspecific 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 commercialrelevant 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 nextgeneration purification processes endtoend.

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.