Scientist 3 - Process Development

Scientist 3, Process Development

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 cultivating career growth and development.

ROLE SUMMARY

We are seeking a highly motivated engineer or scientist to lead or support process development and manufacturing of large molecule biopharmaceuticals. The Scientist will be expected to design and execute studies to develop process parameters, evaluate limits, assess robustness and recommend optimum process conditions for purification and filtration processes. The Scientist will also be responsible for scaling-up the developed processes to pilot and/or manufacturing scale to gain a full understanding of how bench-scale development culminates into viable clinical or commercial processes. The Scientist may also be involved in selected areas of GMP manufacturing operations where significant technical expertise is required. 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

• Design and execute cell culture and/or protein purification studies at bench and pilot scale to develop bioprocessing steps for monoclonal antibodies and other complex biologics.
• Design experiments, analyze and evaluate data and make sound conclusions based on scientific principles and statistical methodologies.
• Establish appropriate set-points and ranges leading to robust and repeatable process performance.
• Support pilot and clinical manufacturing as needed.
• Challenge current paradigm to significantly improve cell culture productivity, process yield and efficiency through implementation of new technologies, optimization of platforms and improved raw materials.
• Operate automated and semi-automated small and pilot-scale bioreactors and protein purification systems.
• Utilize high-throughput cell culture and purification equipment such as ambr15, ambr250, and Tecan liquid handlers.
• Perform process scale-up to pilot or clinical manufacturing scale equipment using engineering principles.
• Perform in-process analytical testing using Nova, cell counters, Solo VPE, Octet and other technologies.
• Perform simple product quantity and quality analyses using technologies such as HPLC and UV/VIS spectrophotometers.
• Working in teams, plan and schedule studies, develop timelines and create raw material usage plans.
• Document laboratory data and experimental results in laboratory notebooks on an everyday basis.
• Write technical reports, verify data, and present experimental results in departmental or cross-functional meetings.
• Follow good documentation practices, safety requirements and all department and company policies.

REQUIRED QUALIFICATIONS

• 2-4 years of hands-on experience with process development studies using bench or pilot scale bioreactors, chromatography systems and filtration equipment.
• Experience with mammalian cell culture systems and/or purification of antibodies or biologics.
• Experience with operation and maintenance of in-process analytics such as Nova, cell counters, ELISA plate readers, HPLC systems, SOLO VPE, Octet or other relevant technologies.
• Experience of authoring technical reports, brief technical presentations and conference posters and abstracts.
• Experience of design of experiments, simple statistical analysis and data interpretation.

PREFERRED QUALIFICATIONS

• 4 or more years of experience in process development studies using bench or pilot scale bioreactors, chromatography systems and filtration equipment.
• Experience in GMP manufacturing of biopharmaceuticals.
• Knowledge and experience demonstrated by scientific accomplishments with high productivity cell lines, cell culture systems or highly innovative protein purification strategies.
• Knowledge of assay development and execution.
• Experience with use of engineering principles to perform process scale-up.
• Experience of media and/or feed optimization to significantly increase cell culture productivity.

REQUIRED EDUCATION

• Bachelor's degree in the life sciences, chemical or biochemical engineering or related field required.
• Master's or higher degree in the life sciences, chemical or biochemical engineering or related field preferred.
• 4 years industry experience with process development studies using bench or pilot scale bioreactors, chromatography systems and filtration equipment.

NextCure, Inc. is committed to equal opportunity and affirmative action in employment. The company ensures non-discrimination in all its employment practices. Every qualified applicant is considered for employment without attention to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, status as a protected veteran, genetic information, age, or any other characteristic protected by law.