Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.
CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.
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.
- 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
- 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.
- Minimum 3 year’s of experience with ELISA and similar techniques
- 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.