Process Dev Engineering Principal Scientific Associate

JOBTITLE: Process Dev Engineering Principal Scientific Associate

LOCATION: 50 Northern Avenue Boston Massachusetts 02210

OPENINGS: 1

DUTIES:

• Support the development of robust scaled upstream or downstream production processes and methods for cell and gene therapy projects.

• Perform stem cell expansion and differentiation in bench-scale bioreactors to support media development and optimization using high-throughput bench scale systems (Ambr15/Ambr250).

• Development and documentation of protocols and technologies in support of upstream and downstream cell product development from clinical to commercial scale.

• Apply DoE/QbDprinciples in process development and characterizationestablishingprocess parameters and contributing to CMC sections of regulatory filings.

• Transfer processes to internal manufacturing and CDMOs providing documentation training and technical support to ensure successful scale-up and implementation in cGMP environments.

• Plan execute and document experiments and data analyses in support of process improvement.

• Draft study protocols and reports while ensuring data integrity.

• Contribute to technical reports regulatory filings source documents patents and external publications.

• Prepare data analysis and deliver technical presentations to both the internal and external stakeholders in the process development department.

• Utilize industry standard quality management tools (RCA FMEA) to troubleshoot and continuously improve process issues.

• Collaborate with cross-functional teams to meet project deliverables by providing technicalexpertisefrom lab experiment results to enable data-driven decisions for key stakeholders.

REQUIREMENTS: Employer will accept aMastersdegree in Biotechnology Science Engineeringor a related field and3years of experience in the job offered or inProcess Dev Engineering Principal Scientific Associate-related occupation.

Alternatively employer will accept aBachelors degree in Biotechnology Science Engineering or a related field and 5 years of experience in the job offered or in a Process Dev Engineering Principal Scientific Associate-related occupation.

Position requires demonstrable experience in the following:

• Experience in process development optimization and characterization using DoE/QbDapproaches for cell therapy products in ongoing and future projects.
• Exceptional aseptic techniques and hands-on cell culture laboratory experience with stem cells and mammalian cells in bench or bioreactor systems.
• Experience with small-scale bioreactors with working knowledge of scale-up parameters and strategies.
• Hands-on experience with routine and product-specific cell culture assays including cell counting metabolite analysis flow cytometry morphologyddPCR nucleic acid and protein assays stem cell isolationselectroporationand cell harvest methods.
• Experience in potency and efficacy assay development and execution to evaluate the product quality profile of cell therapy products.
• Experience with data analysis and statistical software including GraphPad Prism JMP and Excel to support process optimization and cell culture studies
• Documentation and technical report writing to support research deliverables regulatoryfilingsand commercial milestones.
• Knowledge of cell therapy product profiles including iPSC-derived cell therapy products hematopoietic stemcellsand other mammalian cells.
• Deep understanding of 2D/3D stem cell culture expansion and differentiation in high throughput cell culture systems.
• Experience transferring processes to internal manufacturing or CDMOs including preparation of technical documentation training and technical support for cGMP implementation.
• Utilizationof industry-standard quality management tools (RCA-FMEA) to troubleshoot process deviations and continuously improve the process.
• Strong molecular biologyexpertisewith CRISPR/Cas9 genome editing technologies including assay development to evaluate editing efficiency and therapeutic performance.