Bioprocess Associate II / III
- NextCure, Inc.
- Beltsville, MD
- Start date
- Mar 11, 2023
- Manufacturing & Production, Manufacturing/Mechanical, Process
- Required Education
- Bachelors Degree
- Position Type
- Full time
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.
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.
- 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.
NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. We view the immune system holistically and, rather than target one specific immune cell type, we focus on understanding biological pathways, the interactions of cells and the role each interaction plays in an immune response. Through our proprietary Functional, Integrated, NextCure Discovery in Immuno-Oncology, or FIND-IO, platform, we study various immune cells to discover and understand targets and structural components of immune cells and their functional impact in order to develop immunomedicines. We are focused on patients who do not respond to current therapies, patients whose cancer progresses despite treatment and patients with cancer types not adequately addressed by available therapies.
Cancer is a complex disease where cells in the tumor microenvironment promote tumor progression, immune evasion and suppression of anti-tumor immune responses. While therapies targeting inhibitory or immune checkpoint molecules have shown important success in many cancers, not all patients benefit from these therapies (non-responders), and many develop resistance after initial treatment. NextCure is identifying novel tumor-specific interactions and mechanisms of immune regulation to generate a sustainable product pipeline to address these patients in need.
NextCure brings significant experience and innovation in cancer immunology. The company’s FIND-IOTM technology provides a large repertoire of function-based screens and imparts a unique understanding of cell surface molecular interactions between immune and diseased cells. We are using this important knowledge to rapidly develop and advance novel biologics that impact suppressive myeloid cell populations, T cell subsets, and other cell populations within the tumor microenvironment to restore anti-tumor activity and improve clinical response rates and outcomes for patients.
Stock Symbol: NXTC
9000 Virginia Manor Rd. Suite 200
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