Associate Principal Scientist, Vector Engineering and Cell Line Development

We are seeking an Associate Principal Scientist to drive vector engineering and cell line development forlentiviral vector manufacturing.The candidate will play a critical role in building and leading a high-performing function that accelerates AstraZenecas emerging Cell Therapy modalities portfolio.This role focuses on designing andoptimizingplasmids to improve titer safety product quality and compliance and on evaluating and implementing new cell substrates across transient transfection stable packaging and producer cell line systems. You will partner closely with Process Development Analytical Development Quality ManufacturingandRegulatory CMCto translate designs into scalable phase-appropriate processes.This position is based in Gaithersburg MD.

Key Responsibilities

• Plasmid Design & Optimization: Design build andoptimizeplasmids and expression cassettes (promoters enhancers codon usage ITR/LTR elements insulators ORF engineering) to increase vector productivity and quality while reducing recombination risks and plasmid burden.

• Safety Quality & Compliance by Design: Engineer vectors with built-in safety controls (split genomes self-inactivating elements) reduce RCL risk and minimize integration-competent vector species; align designs with global regulatory expectations and internal quality standards.

• Cell Line Strategy & Implementation: Evaluate and implement cell substrates for viral vector production including transient transfection systems stable packaging lines and producer cell lines; compare productivity product quality cost and scalability.

• Stable Line Development: Generate and characterize stable clones (vector integration copy number expression stability growth/production kinetics); implement selection strategies and gene/vector architectures to enhance stability and yield.

• Producer Line Advancement:Collaborate with internal and external partners contribute to the development of inducible/regulated producer cell lines; assess leakiness cytotoxicity and long-term stability; design induction strategies compatible with GMP manufacturing.

• Characterization & Analytics Interface: Define and execute characterization plans linking design choices to critical quality attributes (genome integrity potency residuals empty/full ratios); collaborate with Analytical Development on assays (qPCR/ddPCR NGS ELISA infectivity/potency).

• Tech Transfer & Documentation: Prepare technical reports clone/construct histories sequence maps and development summaries; author transfer packages and support implementation at pilot and GMP sites in alignment with cGMP and data integrity expectations.

• Cross-functional Collaboration:Working with upstream (bioreactor) downstream (purification) and analytical teamstotranslate designs into scalable phase-appropriate processes.

• Innovation & External Scouting: Evaluate next-generation vector backbones promoters regulatory elements and cell engineering tools; assess new cell hosts and media/feed platforms for improved manufacturability.

Qualifications

• Education: PhD in Molecular Biology Cell Biology Bioengineering Virology or related field with58years of industry experience or MS with10years.Titlewill becommensuratewith qualifications and experience.

• Experience: Hands-on experience in plasmid/vector engineering and mammalian cell line development for viral vectors in development or manufacturing contexts.

• Technical Expertise:

• Plasmid construct design cloning sequence verification and optimization for expression and manufacturability.

• Mammalian cell culture in adherent and suspension; development of stable packaging and/or producer lines including vector integration strategies and clone screening.

• Transient transfection optimization at bench and pilot scales; familiarity with single-use bioreactors and scalable transfection workflows.

• Understanding ofvector biology and biosafety (e.g. RCL/RCA risk helper functions split genomes SIN LTRs).

• Analytics & Data:Proficiencywith qPCR/ddPCR sequencing and relevant product analytics; working knowledge of DOE and statistical analysis.

• GMP & Regulatory Awareness: Familiarity with cGMP expectations for starting materials (plasmids cell banks) and phase-appropriate documentation; experience contributing to CMC sections is a plus.

• Communication & Collaboration: Strong written and verbal communication; ability to work cross-functionally and translate designs into process requirements.

Preferred Qualifications

• Experience creating inducible producer cell lines and assessing stability across passages and induction cycles.

• Background in genome engineering (CRISPR/Cas recombinase-mediated cassette exchange safe-harbor integration landing pad strategies).

• Experience with high-throughput clone screening automation and electronic lab systems (ELN/LIMS).

• Demonstrated linkage of vector/cell design changes to manufacturing KPIs (titer potency impurity profile empty/full RCL/RCA).

The annual base pay for this position ranges from $134892.80 - $202339.20. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and 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.

At AstraZeneca we are at the forefront of innovation with constant new products and launches. Our dynamic environment encourages collaboration and problem-solving as we strive to deliver life-changing medicines. We embrace challenges in rapidly changing markets by continuously seeking better ways to deliver medicines to patients. Our team is diverse and connected globally working together to push the boundaries of supply chain excellence. With a focus on sustainability and a commitment to doing things the right way we offer opportunities for growth and development in a supportive environment.

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