Expert / Senior Expert, Science & Technology - Potency

Job Description Summary

As a key member of the Analytical Development team, this individual will support developmental activities to aid in delivering gene therapy to patients. The successful candidate will support technical and development projects designed to characterize gene therapy products through an assortment of analytical methods. This role will also contribute to cross-functional activities including monitoring and characterizing of processes and products to identify opportunities for continuous improvement. Growth mentality and passion to serve patients, his/her technical team and development programs is a must.

 

Job Description

Major accountabilities:

• Performs a wide variety of laboratory tasks and experiments to collaboratively meet established timelines while maintaining high quality and data integrity. 

• Provides detailed observations, analyze data and interpret results. 

• Authors experimental reports, summaries and protocols. 

• Reviews and approves data generated by other team members. 

• Develops, optimizes, and leads qualification of bioassays suitable for gene therapy characterization, lot release and stability monitoring, may participate in assay transfer to QC department.  

• Continuously identified areas of improvement to ensure effective laboratory operations. 

• Performs analytical testing including relative potency assay, protein expression assay, flow cytometry, cell count, cell viability, qPCR/dPCR, etc. 

• Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiency. 

• Assist in drafting and reviewing technical and regulatory documents to ensure completeness, accuracy, consistency and clarity. 

• Present results and project updates to team 

• Work according to appropriate GMP/GLP regulations and Novartis SOPs/Guidelines and Code of Conduct.  

• Other related job duties as assigned.   

Requirements:

Expert:

• Bachelor's degree in biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline with > 2 years of prior industry experience required. BS with > 5 years, MS with >2 years, Ph.D. with >1 year experience preferred  

• Strong understanding and working knowledge of Cell Biology, protein, and DNA chemistry. 

• Strong understanding and working experience with cell-based assays and other plate-based assays using variety of platforms including ELISA, flow cytometry, PCR, MSD, high-content imaging, and luminescent/fluorescent plate reader. 

• Quick learner, highly motivated, hard-working and detail oriented.  

• Expertise with aseptic technique and mammalian cell culture experience a plus 

• Strong ability to work in a fast-paced team environment with highly goal-oriented approaches and to prioritize work from multiple projects with can-do attitude is required.