Senior Expert, Good Manufacturing Practice

Job Description Summary

As a key member of the Analytical Operations team, this individual will support GMP activities to aid in delivering gene therapy to patients. The successful candidate will support development projects designed to release and characterize gene therapy products through an assortment of analytical methods. This role will also contribute to cross-functional activities including monitoring 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

Key Responsibilities:​ 

This role may require 10 hours (8 am - 6 pm; 10 am - 8 pm) a day, 4 days a week shift.

• Serves as SME (Subject Matter Experts) in analytical method qualification, transfer, validation and life cycle management for several GMP assays, such as AUC (Analytical Ultracentrifugation), cell-based potency, ELISA (Enzyme Linked Immunosorbent Assay), PCR,(qPCR and dPCR) flow cytometry, next generation sequencing and separation assays.  

• Plays an active role in establishing the site GMP lab operations to support development and commercialization of new gene therapy medicines. 

• Design, participate and/or oversee method qualification/transfer/validation strategy, protocol and execution.  

• Routine sample testing under GMP or non-GMP modes (in-process, release, and stability), laboratory maintenance and reviews and trends analytical results.  

• Manages the procurement, implementation, use, and maintenance of equipment, instrumentation, and computer systems.  

• Writes and revises documents such as SOPs (Standard Operation Procedures), method validation/transfer protocols, and technical reports.   

• Leads investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.   

• Identifies and implements innovative technologies to improve the compliance and efficiency of GMP operations.  

• Represents GMP to work with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs.  

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

• Bachelor's degree in Biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline with > 4 years of prior experience in academia or industry 
• At least 4 years experience in a GMP laboratory preferred. 

• Possess strong understanding of GMP testing operations and provide expertise in several assays such as AUC, cell-based potency, flow cytometry, ELISA, PCR, and separations-based assays. 

• Strong expertise in method qualification/validation/transfer and familiarity with ICH guidelines 

• Ability to work independently on problem solving, lab investigations, and implementation of preventative and correc