Associate Scientist, Downstream Process Development; PD

Associate Scientist, Downstream Process Development (PD)

Pennington, NJ

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.

Pro Bio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. Pro Bio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.

The individual functions with supervision as Associate Scientist and is actively engaged in downstream plasmid DNA purification process development and doing small scale customer orders (CMC) within a dynamic project team. Displays strong technical knowledge, initiative, and scientific commitment and makes significant scientific and technical contributions within cross functional PD group.

• Process Development:
  Collaborate with the team to design, develop, and optimize downstream processes for purifying plasmid DNA.
• Experimental Work:
  Execute small scale customer orders in CMC work space, work with supervision on experiments and studies for Pre-CMC and CMC productions, evaluation of purification processes, including but not limited to bacterial lysis, chromatography, filtration, and ultrafiltration/diafiltration (UFDF) techniques. Focus on yield, purity, and process efficiency improvements.
• Documentation:
  Prepare detailed process documentation, including standard operating procedures (SOPs) and batch records. Maintain accurate and organized records of experiments and results in form of lab notebook.
• Scale‑Up and Tech Transfer:
  Assist in the scale‑up of processes for larger‑scale production. Participate in technology transfer activities to enable successful process implementation in manufacturing.
• Collaboration:
  
  Collaborate effectively with cross‑functional teams, including upstream process development, analytical development, quality control, and manufacturing teams.
• Regulatory Compliance:
  Ensure all activities adhere to regulatory guidelines and quality standards. Contribute to regulatory submissions and audits as needed.
• Safety and Compliance:
  Adhere to safety protocols and promote a safety culture in the laboratory.

• Bachelor's or Master's degree in a relevant scientific discipline (e.g., Biochemistry, Biotechnology, Chemical Engineering).
• Bachelor’s 1-3yrs. And Master’s 0-1yrs. Demonstrated experience in downstream process development, ideally in plasmid DNA purification, viral vector, or protein purification.
• Hands‑on experience with AKTA, FPLC, Chromatography, Filtration, Nanodrop and UF/DF techniques is highly desirable.
• Knowledge and experience in buffer and reagent preparation, including pH and conductivity measurement, molarity calculation, and density measurement.
• Strong communication skills, both written and verbal, and the ability to collaborate effectively within a team.
• Effectively communicates results of own work through client meetings, presentations, discussions, and documentation with input from supervisor.
• Self‑motivated, detail‑oriented, and able to work independently with minimum supervision.
• Flexibility to adapt to changing project priorities and timelines.
• Individual is required to sit, stand, and walk regularly; able to lift 10–50 pounds regularly.
• Be accessible to lab and office areas to interact with staff and use required office and lab equipment.
• Specific vision…