Senior Bioprocess Engineer, Protein Production
Genocea Biosciences
(Cambridge, Massachusetts)Genocea finds targets of T cell responses to discover and develop life-changing medicines. We’ve created a pipeline of novel vaccine and immunotherapy programs that stimulate the T cell arm of the immune system, which is increasingly recognized as critical to generating protective immune responses against a wide array of diseases.
We are seeking an experienced Bioprocess Engineer to join our Protein Production team to contribute to the development of protein-based vaccines for the prevention and treatment of infectious diseases with significant impacts on human health.
- Provide support for tech transfer, process characterization, manufacturing and process validation campaigns occurring at CMOs (on-site as needed)
- Develop and maintain strong working relationships with CMO technical personnel
- Carry out data trending and statistical analyses of these campaigns
- Facilitate risk assessments, including developing mitigation strategies and
- Liaise with CMOs to finalize risk assessments, control strategies, process characterization/validation protocols and reports
- Assist manufacturing teams to achieve cost effectiveness and optimal product quality
- Employ data analysis methods and techniques, including multivariate methods
- Help develop technical strategies and scale down studies to provide a science-based approach for the resolution of deviations, investigations and process issues
- Experience with cGMP activities and environment
- Solid understanding of DSP development and optimization, including harvest recovery, chromatography (Akta/Avant) and UF-DF
- Demonstrated expertise in DOE, QbD and Design Space concepts
- Knowledge of scale-up and scale-down models
- Must be flexible and able to work well within a fast-paced, dynamic and team-oriented start-up environment
- Must possess solid organizational, interpersonal and problem solving skills
- B.S. (8-plus years industrial experience) or M.S. (6-plus years industrial experience) degree in Chemical/Biochemical Engineering
- Relevant work experience in vaccines manufacturing would be a plus
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- Assessments
- Data Analysis
- Design
- Manufacturing
- Optimization
- Chemical Engineering
- Liaise
- Current Good Manufacturing Practice (CGMP)
- Akta Avant
- Diafiltration (DF)
- Ultrafiltration (UF)
- Quality by Design (QbD)
- Design Of Experiments (DOE)
- Design Space
- Scale-Up Model
- Scale-Down Model
- Biochemical Engineering

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