Expert/Senior Expert Science & Technology - Chemistry

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 chromatography (HPLC), Capillary electrophoresis (CE), mass spectrometry (MS) based and other biophysical assays 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 chromatography (HPLC), Capillary electrophoresis (CE), mass spectrometry (MS) based and other biophysical assays 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:

The level of the role is commensurate to experience/education.

For Expert level:

• Bachelor's degree in Analytical Chemistry, 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 chromatography (HPLC), Capillary electrophoresis (CE), mass spectrometry (MS) based and other biophysical assays 

• Working knowledge on analytical software including but not limited to Chromeleon, Empower, Chemstation, Astra, 32Karat, Xcalibur, Mascot, and Byonic a plus. 

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

• Strong ability to work in a fast-paced team environment with highly goal-ori