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Bioprocess Associate, Manufacturing

2 months ago

Beltsville, United States NextCure Inc Full time
Job DescriptionJob Description

NextCure is a clinical-stage biopharmaceutical company located in Beltsville, Maryland, 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 to cultivate interdisciplinary career growth and development.

NextCure is seeking an experienced and highly motivated Bioprocess Associate to support manufacturing and process development of large molecule biopharmaceuticals. The Bioprocess Associate will be expected to write and execute SOP’s, batch records, deviations, and CAPA’s in a cGMP environment in support of manufacturing clinical materials. The Bioprocess Associate will also be responsible for supporting process development work and assist in scaling-up the developed steps to pilot and/or manufacturing scale. 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

  • Perform pilot and clinical manufacturing of drug substance for human use
  • Operate automated and semi-automated development, pilot and clinical-scale bioreactors, and protein purification systems
  • 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 relevant equipment and technologies
  • Perform simple product quantity and quality analyses using technologies such as HPLC
  • Working in teams, plan and schedule tasks, develop timelines and create raw material usage plans
  • Follow good documentation practices, safety requirements, and all department and company policies

Required Experience

  • 2+ years of hands-on experience with execution of bioreactors or standard chromatography and filtration techniques applied in the bioprocessing industry
  • Experience with standard manufacturing technologies and instrumentation
  • Experience with operation and maintenance of in-process analytics such as Nova, cell counters, pH/conductivity meters, SOLO VPE, or other relevant technologies

Preferred Qualifications

  • 2 or more years of experience in GMP manufacturing of biopharmaceuticals using bioreactors, chromatography systems and filtration equipment
  • Experience with Sartorius STR bioreactors and/or AKTA chromatography systems

Education

  • Bachelor’s degree in life sciences, chemical, biochemical engineering, or related field preferred

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.