ProBio-Scientist, Downstream Process Development (PD) and MSAT

Job Scope:

The individual functions with supervision as Scientist I II or III and is actively engaged in downstream plasmid DNA purification process development and MSAT within a dynamic project team. Displays strong technical knowledge, initiative, and scientific commitment and makes significant scientific and technical contributions within PD & MSAT group.

Position Information:

Worl Location: Piscataway, NJ/Hopewell, NJ

Reports to: Manager of PD Downstream and MSAT

Roles and Responsibilities:

• Process Development: Collaborate with the team to design, develop, and optimize downstream processes for purifying plasmid DNA or proteins.
• Experimental Work: Execute experiments and studies for PreCMC 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.
• Data Analysis: Analyze and interpret experimental data, troubleshoot any issues that arise during process development, translate data into findings, draw sound conclusions, and propose improvement solutions.
• Technology Assessment: Stay updated on the latest downstream processing technologies and techniques advancements. Evaluate and recommend new methods or equipment for process enhancement.
• Documentation: Prepare detailed process documentation, including standard operating procedures (SOPs), batch records, and technical reports. Maintain accurate and organized records of experiments and results.
• 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.

Qualifications:

• Bachelor's with minimum 4 years of industry experience or Master's degree with 6 years of experience in a relevant scientific discipline (e.g., Biochemistry, Biotechnology, Chemical Engineering).
• Demonstrated experience in downstream process development, ideally in plasmid DNA purification, viral vector, or protein purification.
• Hands-on experience with chromatography, filtration, 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.
• Proficiency in data analysis and laboratory techniques, including statistical analysis software and relevant bioprocess software.
• 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.
• Familiarity with regulatory requirements and quality compliance in the biopharmaceutical industry is a plus.
• 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
• The ability 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 requirements include reading of written documents and frequent use of computer monitors
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