Associate Scientist III, Vector Production, Viral Vector Product Development

This is what you will do:

Alexion AstraZeneca Rare Disease is seeking a full-time Associate Scientist to join our AAV manufacturing team supporting both upstream and downstream activities for AAV production. The role will execute and optimize process conditions contribute to technology transfer and drive continuous improvement with a strong focus on chromatographic purification Tecan liquid handling systems and data-driven decisions for production analytics.

You will be responsible for:

• Downstream operations: Execute clarification chromatography (affinity and IEX) TFF buffer exchange and concentration and formulation with conditions aligned to outputs from Ambr250 through 50L assist in DoE-driven optimization.
• Automation and high-throughput: Program operate and troubleshoot Tecan platforms for sample prep plate-based screening fraction handling buffer preparation and in-process testing support integrated into upstream/downstream unit ops.
• Process Analytics and visualization: Use JMP to analyze and interpret production run data (multivariate analysis control charts variability analytics regression/ANOVA DoE modeling); build dashboards and reports to communicate insights and drive decisions. Coordinate and interpret in-process controls and CQAs (vg titer capsid ratio purity HCP/residuals) in partnership with analytical teams summarize data to inform scale-up decisions.
• Documentation and Compliance: Author and maintain SOPs study protocols batch records and technical reports; ensure adherence to safety data integrity and Alexion/AZ quality standards.
• Continuous improvement: Identify opportunities to improve yield robustness and throughput across the Ambr250-50L scale range contribute to platformization and digital/automation initiatives with a focus on implementation of AI.
• Upstream operations: Assist with upstream operations using bioreactors ranging from Ambr250 to 50L stir tanks as needed.

You will need to have:

Qualifications / Training & Education

• Bachelors degreein Biochemistry Bioengineering Chemical Engineering Molecular Biology or related field with a minimum of 4yrs of relevant experience or MS with 2 yrs experience inviral vectororbiopharmaceuticalproduction or process development.
• Basic understanding of Good Laboratory Practices for bioprocessing manufacturing & analytics

Knowledge & Experience

• Strong track record of building successful relationships with supervisors peers suppliers customers partners and stakeholders
• Excellent communication skills and ability to collaborate well with multiple individuals.
• Ability to work on several projects simultaneously and to switch focus as needed.
• Ability to keep accurate and organized records.

Technical Competencies

• Knowledge of and direct experience with chromatography-based purification column cleaning and column packing.
• General molecular/microbiology skills
• Expertise in aseptic technique
• Track record of prioritizing multiple complex high priority tasks and ensuring timely delivery to meet project needs.
• A strong attention to detail
• Working knowledge of Microsoft Office products especially Microsoft Excel
• Proficiency using statistical analysis of bioprocess data including DoE design and analytics control charting regression/ANOVA and multivariate visualization; ability to translate findings into actionable process recommendations.
• Practical experience with Tecan liquid handling systems supporting upstream and downstream workflows (sample prep plate screening fraction collection buffer preparation)
• Working knowledge of AAV production modalities (transient transfection or producer cell lines) mammalian cell culture and downstream unit operations (clarification chromatography TFF) suitable for Ambr250 up to and including 50L outputs.
• Effective communication collaboration and problem-solving skills in cross-functional settings.
• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role employees must be able with or without an accommodation to: lift 15 pounds unassisted; work comfortably in a controlled environment with and around biological infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and non-linear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

Strong Preference to Candidates with:

• Experience with AAV process development and troubleshooting (upstream & downstream)
• Expertise with Unicorn software and writing methods as well as packing cleaning and testing of chromatography columns.
• Expertise in statistical analysis of bioprocess data
• Experience with analytical assays related to AAV.
• Proficiency with Delta-V software and writing methods.
• Experience with upstream bioreactors including Ambr250 Wave and 50L stir tanks.

Location and Work Model:

Location: Durham NC

Work Model: On-site limited travel (<10%) may be required for technology transfer or vendor interactions.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.