AstraZeneca GmbH
Associate Principal Scientist, Vector Engineering and Cell Line Development
AstraZeneca GmbH, Durham, North Carolina, United States, 27703
We are seeking an Associate Principal Scientist to drive vector engineering and cell line development for lenti viral vector manufacturing. The candidate will play a critical role in building and leading a high‑performing function that accelerates AstraZeneca’s emerging Cell Therapy modalities portfolio. This role focuses on designing and optimizing plasmids 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, Manufacturing, and Regulatory CMC to translate designs into scalable, phase‑appropriate processes. This position is based in Gaithersburg, MD.
Key Responsibilities
Plasmid Design & Optimization: Design, build, and optimize plasmids 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 teams to translate 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 with 5–8 years of industry experience or MS with 10+ years. Title will be commensurate with 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 of vector biology and biosafety (e.g., RCL/RCA risk, helper functions, split genomes, SIN LTRs).
Analytics & Data: Proficiency with 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 $134,892.80 - $202,339.20 USD. Base pay offered may vary depending on multiple individualized factors, including market location, job‑related knowledge, skills, and experience. In addition, positions offer a short‑term incentive bonus opportunity; eligibility to participate in an equity‑based long‑term incentive program. Benefits include 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. If hired, the employee will be in an “at‑will” position and the Company reserves the right to modify base pay at any time.
Date Posted: 09-Jan-2026
Closing Date: 29-Jan-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Join us in making a difference—apply today!
#J-18808-Ljbffr
Key Responsibilities
Plasmid Design & Optimization: Design, build, and optimize plasmids 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 teams to translate 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 with 5–8 years of industry experience or MS with 10+ years. Title will be commensurate with 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 of vector biology and biosafety (e.g., RCL/RCA risk, helper functions, split genomes, SIN LTRs).
Analytics & Data: Proficiency with 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 $134,892.80 - $202,339.20 USD. Base pay offered may vary depending on multiple individualized factors, including market location, job‑related knowledge, skills, and experience. In addition, positions offer a short‑term incentive bonus opportunity; eligibility to participate in an equity‑based long‑term incentive program. Benefits include 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. If hired, the employee will be in an “at‑will” position and the Company reserves the right to modify base pay at any time.
Date Posted: 09-Jan-2026
Closing Date: 29-Jan-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Join us in making a difference—apply today!
#J-18808-Ljbffr