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BioProcess Engineer / Process Engineer 3

NextCure Inc
Beltsville, MD
  • Posted: over a month ago
  • Full-Time
Job Description

NextCure is a publicly traded 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.

We are seeking a highly motivated Scientist or Engineer to lead or support process development of large molecule biopharmaceuticals. The Scientist will be expected to follow and maintain project timelines and milestones, and design and execute studies to develop process parameters, evaluate limits, assess robustness, and recommend optimum process conditions for downstream purification steps. The Scientist will also be responsible for scaling-up the developed 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, use sound scientific principles, and ultimately play a critical role in bringing innovative therapies to patients.

Responsibilities

  • Perform purification process development of protein therapeutics (e.g., monoclonal antibodies, fusion proteins, antibody-drug conjugates, etc.), and technology transfer of production processes into GMP manufacturing.
  • Working in teams, plan, and schedule studies, develop timelines, and create raw material and equipment usage plans.
  • Design and execute appropriate experiments to evaluate various process conditions using DOEs, analyze, and evaluate data and make sound conclusions based on scientific principles and statistical methodologies.
  • Author technical reports and technical presentations to summarize findings in departmental and cross-functional meetings.
  • Establish appropriate set-points and ranges leading to robust and repeatable process performance.
  • Challenge current paradigm to significantly improve process yields and efficiency through implementing new technologies, optimizing platforms and improved raw materials.
  • Operate automated and semi-automated small and pilot-scale protein purification systems.
  • Utilize high-throughput technologies such as Tecan Liquid Handler, as appropriate.
  • Perform process scale-up to pilot or clinical manufacturing scale equipment using engineering principles.
  • Provide subject-matter expertise and support pilot and clinical manufacturing, as needed.
  • Perform in-process analytical testing using Solo VPE and other technologies.
  • Perform simple product quantity and quality analyses using technologies such as HPLC or UPLC.
  • Bring new technology concepts to couple unit-operations, evaluate new chromatography media and assess process analytical technologies.
  • All other duties as assigned.


Basic Qualifications

  • 4 or more years of experience in process development of downstream; hands-on experience with process development studies using bench or pilot scale bioreactors, chromatography systems, and filtration equipment.
  • Experience with downstream purification of monoclonal antibodies or biologics, and operation and maintenance of in-process analytics such as Nova, cell counters, HPLC/UPLC systems, SOLO VPE, AKTA chromatography systems, or other relevant technologies.
  • Experience with technology transfer of purification processes into GMP manufacturing
  • Demonstrated experience authoring technical reports, technical presentations, and conference posters and abstracts.
  • Experience with experiment design, statistical analysis, and data interpretation.
  • Demonstrated ability to handle multiple, simultaneous projects in a fast-paced cross-functional team environment.
  • Experience with the use of engineering principles to perform process scale-up.
  • Knowledge developing connected processes.
  • Experience of participating as departmental representative in cross-functional product development teams.
  • Interest in working for a start-up in transition to a growing product development company, offering opportunities for professional growth.

Preferred Experience

  • Ph.D. in the life sciences, chemical or biochemical engineering, or a related field
  • Demonstrated experience with statistical experiment design, statistical analysis, and data interpretation.
  • Experience developing cell culture and purification processes together in an “all-stream” approach.
  • Knowledge of techniques utilized for biophysical analysis of proteins such as mass spectrometry, dynamic light scattering, MALS, reverse phase HPLC, and UV-Vis spectrophotometry
  • Experience with authoring technology transfer documents including sampling plans, bill of materials, and process description
  • Experience with writing SOP’s, batch records, deviations, and CAPA’s
  • Knowledge and experience demonstrated by scientific accomplishments with high productivity processes or highly innovative protein purification strategies.
  • Prior work history authoring Chemistry, Manufacturing, and Controls (CMC) sections of regulatory documents.

Required Education

  • Bioprocess Associate III candidates will have a Bachelor’s degree in the life sciences or a closely related field. A Master’s degree in a related field is preferred.
  • Process Engineer III candidates will have a Bachelor’s degree in chemical, biochemical, biomedical, or bioprocess engineering or a closely related field. A Master’s degree in a related field is preferred.
  • Perform process scale-up to pilot or clinical manufacturing scale equipment using engineering principles.


NextCure, Inc. is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

NextCure Inc

Address

Beltsville, MD
20705 USA

Industry

Manufacturing

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