Summary
The Research Associate will execute testing with regards to the analytical method development for cell and gene therapy products with a multidisciplinary R&D team focused on developing innovative assays for cell and gene therapy products.
Responsibilities
- Execution of testing in an R&D & GMP laboratory
- Collaborate with a diverse team to develop new assays for cell and gene therapy applications.
- Conduct cell-based, molecular and analytical assays
- With supervision design, execute and interpret experiments to meet R&D objectives.
- Develop presentations and communicate technical results to internal technical groups.
- Maintain accurate laboratory records and draft technical reports to comply with good laboratory practices. and standard operating procedures.
- Work with scientists to transition assays to GMP
- Generate, analyze, and record high-quality data using documentation, and database tools.
- Maintain laboratory records and contribute to laboratory organization and maintenance.
- Independently develop, optimize, and qualify analytical methods to characterize viral vector and cell therapy products.
- Perform and coordinate analytical testing in support of process development, cGMP investigations and product characterization.
- Designs and executes experiments to characterize RCT drug product for protein expression, cell metabolism and lipid structure and function.
- Identifies critical product quality attributes in RCT drug product through forced degradation and structure-function related studies.
- Characterize process and product related impurities in cell product and viral vector in collaboration with process development teams.
- Evaluate new technologies to assess biophysical and biochemical properties of RCTs.
- Participate in the support of analytical activities related to analytics including method qualification, data trending, troubleshooting, optimization, review and reporting.
- Reviews, interprets and communicates data cross-functionally within the organization.
- Attend, participate in, and present results at cross-functional team meetings.
- Author reports and source documentation to support regulatory filings.
Education & Experience
- Bachelor’s Degree in Biology, Biochemistry, Molecular Biology, Immunology or related discipline
- Minimum 3 years’ experience in cell and molecular biology, biochemistry, chemical engineering, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.
- Demonstrated ability to conduct and interpret experiments to meet technical objectives
- Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal
- A proven ability to collaborate with team members to complete projects in an efficient and timely manner.
- Capability and desire to work in a dynamic, fast-paced, innovative environment
- Prior experience with cell culture, ELISA and flow cytometry techniques is highly desirable
- Prior exposure to GMP, ISO regulated environment is a desirable
- Independently troubleshoot experiments and contribute to research directions
- Understanding of compliance and cGMP considerations.
