Senior Associate Scientist

Responsibilities

• Upstream support:
  Assist with cell expansion, transfection, and bioreactor (Ambr
  250 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.

• 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.
• 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
• Familiarity with AAV production including transient transfection, suspension platforms and core downstream unit operations
• Experience with single-use bioreactors (Am , 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.
• Direct experience with AAV production (upstream and downstream) at lab or pilot scale
• Experience with analytical assays related to AAV
• Hands on experience with upstream bioreactors including Ambr
  250, Wave, and 50L stir tanks