Downstream Biologics Scientist - Pilot-Scale & PPQ Lead

Jobtailor; New Jersey; On-site; USD 105,000 - 145,000; Full time

Job summary

Jobtailor in New Jersey seeks a Biologics Process Scientist to lead hands-on experiments in downstream processing of monoclonal antibodies, perform lab-scale process characterization, and drive pilot-scale development.

You will develop scale-up/scale-down models, collaborate with commercial manufacturing as a process sciences representative, and support facility start-up and in-line activities while providing on-the-floor support for drug substance manufacturing.

Qualifications

• Bachelor's degree or higher in Chemical Engineering, Chemistry, Biology or related field.
• 2+ years of experience with downstream processing of monoclonal antibody (mAb) products or similar products in a laboratory or manufacturing setting.
• Experience with membrane filtration, preparative chromatography, ultrafiltration or tangential flow filtration, and viral clearance.
• Mechanistic understanding of downstream processing separation sciences.
• Ability to execute experiments independently while meeting quality and timeline expectations.
• Well-developed communication, organizational, and problem-solving skills, with attention to detail.
• 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 preferred.
• No visa sponsorship.
• 10% travel requirement.

Responsibilities

• Lead hands-on experiments in biologics downstream processing
• Perform lab-scale process characterization
• Conduct 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 activities
• Provide on-the-floor support for drug substance manufacturing as needed
• Author and/or review technical documents supporting PPQ and licensure

Skills

Downstream Processing

Process Characterization

Scale-Up/Down

Membrane Filtration

Preparative Chromatography

Ultrafiltration

Tangential Flow Filtration

Viral Clearance

PPQ

Mechanistic Understanding

Risk Assessment

Control Strategy

cGMP Awareness

Communication

Organization

Problem Solving

Attention to Detail

Education

Bachelor’s degree or higher in Chemical Engineering, Chemistry, Biology or related field

Job description

Jobtailor in New Jersey seeks a Biologics Process Scientist to lead hands-on experiments in downstream processing of monoclonal antibodies, perform lab-scale process characterization, and drive pilot-scale development.

You will develop scale-up/scale-down models, collaborate with commercial manufacturing as a process sciences representative, and support facility start-up and in-line activities while providing on-the-floor support for drug substance manufacturing.