Biologics Downstream Scientist: Scale-Up & PPQ

Jobtailor; New Jersey; On-site; USD 90,000 - 120,000; Full time

Job summary

Jobtailor is seeking a process sciences candidate to execute biologics downstream processing on lab and pilot scales, with hands-on experimentation and data analysis. You will develop scale-up/scale-down models and collaborate with manufacturing teams to support drug substance production.

The role requires a degree in a relevant science, strong documentation skills, and ability to work independently with quality and timelines in mind.

Qualifications

• Bachelor’s degree or higher in a relevant science.
• Experience executing lab activities including study protocols, experiments, data analysis, and technical reports.
• Ability to execute experiments independently while meeting quality and timelines.
• Strong communication, organizational, and problem-solving skills with attention to detail.
• Preferred: experience with downstream processing of monoclonal antibody products or similar.
• Preferred: membrane filtration, preparative chromatography, ultrafiltration or tangential flow filtration, and viral clearance.
• Preferred: large molecule drug substance technology transfer experience.
• Preferred: collaboration with analytical teams, pilot-scale, and/or manufacturing environments.
• Preferred: experience authoring technical documentation for process description, process characterization, process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.
• Preferred: current Good Manufacturing Practice (cGMP) awareness or experience.
• No visa sponsorship
• US and Puerto Rico residents only

Responsibilities

• Execute hands-on experiments in biologics downstream processing
• Perform lab-scale process characterization
• Perform pilot-scale process development
• Develop process scale-up/scale-down models
• Collaborate with commercial manufacturing teams as a process sciences representative
• Support facility start-up and in-line support activities
• Provide on-the-floor support for drug substance manufacturing as needed
• Author and/or review technical documents supporting PPQ and licensure

Skills

Biologics Downstream Processing

Process Characterization

Data Analysis

Experimental Planning

Viral Clearance

Education

Bachelor’s Degree in Chemical Engineering, Chemistry, Biology or comparable discipline

Tools

Preparative Chromatography

Ultrafiltration

Tangential Flow Filtration

Membrane Filtration

Job description

Jobtailor is seeking a process sciences candidate to execute biologics downstream processing on lab and pilot scales, with hands-on experimentation and data analysis. You will develop scale-up/scale-down models and collaborate with manufacturing teams to support drug substance production.

The role requires a degree in a relevant science, strong documentation skills, and ability to work independently with quality and timelines in mind.