Key Responsibilities:​ 

• 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.    

**Shift position** Shift: Tues- Friday and weekend coverage as needed 10 hour shift 8am -6pm. Shift will be fixed according to business need.

Essential Requirements:  

• Bachelor's degree in Biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline with 5 years of prior experience in academia or industry 
• Possess strong understanding of GMP testing operations and provide expertise in several assays such as cell-based potency, flow cytometry, ELISA, PCR, or separations-based assays is required
• Strong expertise in method qualification/validation/transfer and familiarity with ICH guidelines is required
• Ability to work independently on problem solving, lab investigations, and implementation of preventative and corrective actions. 
• Ability to work effectively within the group, within Quality, and across sites. Additional responsibilities include adherence to all GMP requirements, an understanding of FDA/EMEA regulations, effective interactions/communication with Quality management. 
• Demonstrated ability to work collaboratively in a fast-paced team environment and quickly acquire new technical skills and knowledge   

Preferred Qualifications:

• At least 4 years experience in a GMP laboratory preferred.

Novartis Compensation and Benefit Summary

The salary for this position is expected to range between $114,100 and $211,900 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.