Associate Scientist, Analytical Development (Elisa)

Position: Associate Scientist, Analytical Development (Elisa)

Location: King of Prussia (onsite)

Company: Sk Pharmteco

The 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 concept 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. The Associate Scientist will execute in-process analytical testing for cell and gene therapy products with a multidisciplinary Process Development team.

Responsibilities:Execution of testing in development laboratoryCollaborate with a diverse team to execute assays for cell and gene therapy applications.Conduct cell-based and molecular assays with supervision design, execute and interpret experiments to meet 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.Generate, analyze, and record high-quality data using documentation, and database tools.Maintain laboratory records and contribute to laboratory organization and maintenance.Independently execute analytical methods to characterize viral vector and cell therapy products.Perform analytical testing in support of process development, cGMP investigations and product characterization.Characterize process and product related impurities in cell product and viral vector in collaboration with process development teams.

Requirements:Bachelor’s degree in biology or Master degree in Biochemistry, Molecular Biology, Immunology or related discipline.1-2 years’ experience in cell and molecular biology, biochemistry, chemical engineering, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.Minimum 1 year of experience with Master and 2 years with BSc, with in-process analytics and characterization methods including flow cytometry, plate-based assays (ie, ELISA and infectious titer), PCR-based assays (ie qPCR, dPCR, ddPCR), and/or other common analytics highly desired.Demonstrated ability to conduct experiments to meet technical objectivesExcellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbalAbility to collaborate with team members to complete projects in an efficient and timely mannerCapability and desire to work in a dynamic, fast-paced, innovative environmentPrior exposure to GMP, ISO regulated environment is a desirable

Physical Requirements:Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.