Expert Science & Technology - Quality Control, Information Technology
Expert Science & Technology - Quality Control, Information Technology
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$ 77000 - 143000
1 Vacancy
Job Description
Band
Level 3Job Description Summary
Location: East Hanover NJ United States. Position will be onsiteInternal Title: Expert Science & Technology
Join Our Vision: At Novartis we are on a transformative journey in cell and gene therapy pushing the boundaries of medical innovation. We are currently looking for an Expert Science & Technology to join our team and help us deliver high-quality solutions that supports the management of data analytical equipment and computerized system specialist.
Your Role: As the Expert Science & Technology you are responsible to support maintain update and troubleshoot the GMP analytical equipments related items for Cell and Gene Therapies. Additionally the Expert will assist with site projects such as system updates and/or enhancements within tight timelines following guidelines and compliance. Knowledge of GxP regulations is recommended.
This position will be located at East Hanover site and will not have the ability to be located remotely.
Job Description
Key Responsibilities:
- Acts as the SME for GxP lab systems for all analytical instruments in the analytical labs in TRD CGTsuch as Flow cytometer ddPCR UPL NGS Empower etc.
- Ensures the GxP lab systems are in compliance to all regulatory requirements such as 21 CFR Part 11 and Annex 11.
- Day-to-day management and continuous improvement of all GxP lab systems/processes and supports data integrity initiatives related to GxP lab systems
- Works with Analytical Development and Operation teams IT Engineering and Validation to support GxP lab system lifecycle management activities from concept development validation implementation and maintenance to retirement.
- Authors reviews reports on and approves corrective actions to protocols investigations non-conformance CAPAs and other records related to GxP lab systems.
- Reviews identifies and leadsimplementation of improvements to existing lab SOPs and training related to GxP lab systems.
- Lead representation of GxP lab systems during and/or communicates and tracks all follow-up items through to completion.
- Plans and leads large GxP system projects such as LIMS implementation and lab instrument related duties as assigned.
- Position is a Monday-Friday but weekend support may be needed
Requirements:
- Bachelors degree is required. A degree in Biology Biochemistry Molecular Biology Immunology or related scientific discipline is preferred.
- A minimum of 3 years of industry experience in automation/digitalization projects and Pharmaceuticals.
- Experience in instrument administration preferably in CGT
- Strong knowledge of regulatory requirements and industry standards including GxP FDA 21 CFR Part 11 and EU Annex 11.
- Experience with validation lifecycle documentation including URS FRS DS IQ OQ PQ and traceability matrices.
- Working knowledge in SQL Java or other LIMS programming language.
- Experienced in lifecycle management of GxP lab systems.
Desired Requirements:
- LIMS administration a plus.
- Experience working with AAV LVV and cell therapy analytics preferred.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $77000-$143000; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
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
Skills Desired
Agility Audit Management Business Partnering Change Control Continued Learning Health Authorities Influencing Skills Knowledge Of Capa Qa (Quality Assurance) Quality Management Quality Management Systems (QMS) Risk Management Root Cause Analysis (RCA) Self-Awareness Sop (Standard Operating Procedure) Technological ExpertiseEmployment Type
Full-Time
