Bioprocess Associate II / III

NextCure is a clinical-stage biopharmaceutical company located in Beltsville, MD, focused on the discovery and development of first-in-class immunomedicines for the treatment of cancer and other diseases We are committed to professional development in the context of learning, managing, and developing our employees. We create a unique environment for our employees, providing exposure to various facets of our operations and cultivating career growth and development.

Role Summary

We are seeking highly motivated engineers and scientists to lead clinical manufacturing of large molecule biopharmaceuticals. The Bioprocess Associate II/III will be expected to execute operations in the clinical manufacturing plant in writing and execution of SOP’s, batch records, deviations, and CAPA’s. The Bioprocess Associate II/III will also assist with scaling up developed process steps to pilot and/or manufacturing scale to gain a full understanding of how bench-scale development culminates into viable clinical or commercial processes. The successful candidate will work in high-performing teams, collaborate across technical functions, utilize sound scientific principles, and ultimately play a critical role in bringing innovative therapies to patients.

Responsibilities

• Execution of upstream cell culture processes in a pilot and clinical manufacturing of drug targets.
• Write SOPs, Master Production Records, and Batch records.
• Manage deviations, Change Controls, and CAPAs.
• Operate automated and semi-automated small, pilot, and clinical-scale bioreactors and protein purification systems.
• Perform process scale-up to pilot or clinical manufacturing scale equipment using engineering principles.
• Support cell culture and/or protein purification studies at bench and pilot scale to develop bioprocessing steps for monoclonal antibodies and other complex biologics.
• Analyze and evaluate data and make sound conclusions based on scientific principles or statistical methodologies.
• Perform in-process analytical testing using Nova, cell counters, Solo VPE and other technologies
• Perform simple product quantity and quality analyses using technologies such as HPLC
• Working in teams, planning, and scheduling studies, developing timelines, and creating raw material usage plans.
• Experiences with Single-Use-Technology

Required Education and Experience

• Bachelor’s degree in the life sciences, chemical or biochemical engineering or related field.
• 3 years of hands-on experience with the execution of bioreactors or standard chromatography and filtration techniques applied in the bioprocessing industry.
• 2 years’ experience in deviation and CAPA management
• Experience with standard manufacturing technologies and instrumentation
• Experience with mammalian cell culture systems and purification of antibodies or biologics.
• Experience with operation and maintenance of in-process analytics such as Nova, cell counters, pH/conductivity meters, presentations, conference posters, and abstracts.

Preferred Education and Experience

• Master’s or higher degree in the life sciences, chemical or biochemical engineering or related field.
• 4 or more years of experience in process development studies using bench, pilot, or clinical scale bioreactors, chromatography systems, and filtration equipment.
• Knowledge and experience demonstrated by scientific accomplishments with high productivity cell lines, cell culture systems, or highly innovative protein purification strategies.
• Experience writingSOPs, Batch records, deviation management, and CAPAs.
• Experience in media and/or feed optimization to significantly increase cell culture productivity.

NextCure is an Equal Opportunity Employer and offers a competitive salary and benefits package in a scientifically engaged teamwork environment.