Associate Scientist III - Vector Production

Job Title: Associate Scientist III - Vector Production
Viral Vector Product Development
Location: Durham, NC, 22701
Duration: 12 months+ (Possible Extension)

Shift: Mon-Fri

Job Description:
This is what you will do:
Company Rare Disease is seeking an Associate Scientist III to join the Viral Vector Production group in Durham, NC. This role supports both upstream and downstream operations with a particular focus on sample coordination, harvest train activities, and data recording/analysis to enable reliable production of AAV vectors. Candidates with direct, hands-on AAV production experience will be prioritized.

You will be responsible for:

• Upstream support: Assist with cell expansion, transfection, and bioreactor (Ambr250 to 50L stir tank) operations, routine in-process sampling, and monitoring of process parameters.
• Downstream support: Participate in clarification, chromatography, and TFF/filtration steps; assemble/disassemble and clean harvest train components; and stage materials.
• Sample management: Coordinate sample plans across unit operations; label samples accurately and per SOPs; maintain chain-of-custody and timely delivery to QC/analytics.
• Equipment operations: Perform setup, operation, and teardown of harvest trains, pumps, filters, tubing sets, single-use systems, and ancillary equipment; support/perform pre-use checks and readiness.
• Data capture and analysis: Accurately record process data, batch records, and logbooks; compile and analyze data for trends, yields, and process performance; contribute to run summaries and troubleshooting.
• Compliance and quality : Follow SOPs and cGMP/cGLP principles as applicable; support investigations, maintain clean, safe work areas and proper documentation.
• Cross-functional collaboration: Work closely with Manufacturing, Process Development, QC/Analytics, Supply Chain, and Facilities to ensure schedule adherence and issue resolution.
• Continuous improvement: Identify and implement improvements in sampling workflows, equipment readiness, and documentation practices.

You will need to have:
Qualifications / Training & Education:

• BS in Biochemistry, Bioengineering, Chemical Engineering, Molecular Biology, or related field with 4+yrs of relevant experience or MS with 2+ yrs experience in viral vector or biopharmaceutical production or process development.

Knowledge & Experience:

• Strong track record of building successful relationships with supervisors, peers, suppliers, customers, partners and stakeholders
• Excellent communication skills and ability to work 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

• Familiarity with AAV production including transient transfection, suspension platforms and core downstream unit operations
• Experience with single-use bioreactors (Ambr, Wave and 50L Stir Tank), TFF, depth filtration and affinity/ion exchange chromatography
• Knowledge of in-process analytics relevant to AAV (e.g., titer by qPCR/dPCR/ddPCR, capsid protein assays, residual DNA, endotoxin, %Empty/Full assays)
• General molecular/microbiology skills
• Experience 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 with Microsoft Excel
• 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:

• Direct experience with AAV production (upstream and downsteam) at lab or pilot scale
• Experience with analytical assays related to AAV
• Hands on experience with upstream bioreactors including Ambr250, Wave, and 50L stir tanks

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



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