Senior Expert Science & Technology, Good Manufacturing Practice (Tuesday - Friday)

Band

Level 4

Job Description Summary

Internal Title: Senior Expert Science & Technology
LI #onsite
This is an onsite role located in East Hanover NJ

As a key member of the Analytical Operations team the Senior Expert Science & Technology 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:

• 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 theprocurement implementationuseand maintenance of equipmentinstrumentation and computer systems.
• Writes and revises documents such as SOPs (Standard Operation Procedures) method validation/transfer protocols and technical reports.
• Leadsinvestigations to determine root causeof deviationsand non-conforming resultsand 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 workwith other departments includingAnalytical DevelopmentQuality AssuranceandManufacturing 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:

• Bachelors 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 guidelinesis 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 $114100 and $211900 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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$114100.00 - $211900.00

Skills Desired

Continued Learning Dealing With Ambiguity Decision Making Skills Gxp Industry Standards Laboratory Equipment Laboratory Excellence Managing Resources Organizational Savvy Quality Control (Qc) Testing Quality Control Sampling Self-Awareness Smart Risk Taking Technological Expertise Total Quality Management