Expert Science & Technology
Expert Science & Technology
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$ 85400 - 158600
1 Vacancy
Job Description
Job Description Summary
Title: Expert Science & TechnologyThis position will be located at East Hanover NJ site and will not have the ability to be located remotely.
Please note that this role would not provide relocation and only local candidates will be considered.
Under general direction perform microbiological and EM testing and execute other activities and functions to ensure the timely testing and release of products related to development/clinical operations in East Hanover Cell and Gene Therapy GMP facility. Deliver quality products and services on time to all customers internal and external. Monitor processes and products to identify opportunities for continuous improvement. Lead technical projects and collaborate with the team in the design and execution of validation and other projects. Serve as the subject matter expert on specific areas and techniques.
#LI-Onsite
Key Responsibilities:
**Shift position** Work on shifts covering daytime / evening and one or both weekend days. Shift will be fixed according to business needs.
Perform micro and EM testing in support of clinical release strategies.
Perform all testing and activities compliantly following appropriate SOPs and Work Procedures.
Document results within electronic and paper-based systems accordingly. Enter/review data in LIMS as applicable.
Perform review of analytical data and archiving in lab documentation systems. Review QC documents to ensure completeness accuracy consistency and clarity.
Maintain controls and reference standards/materials to support testing.
Ensure cleanliness of laboratory working areas.
Perform laboratory/equipment cleaning as per applicable schedules and procedures.
Draft finalize and revise technical protocols procedures and reports with minimal supervision.
Support and/or manage tracking and trending systems and programs that assist in the testing evaluation and monitoring of quality assay performance and efficiency.
Support external teams in qualifying new and/or replacement equipment within the laboratory.
Ensure assigned analytical methods are ready to be performed when required including management of reagent consumables and equipment inventory.
Job Description
Requirements:
- BS MS or advanced degree in microbiology biology biochemistry or other preferred
- Minimum 3-5 years of relevant experience in the pharmaceutical biologics
microbiology sterile manufacture cell and gene therapy or medical device industry.
- Working knowledge of aseptic manufacturing cGMPs GLPs and applicable compendial and regulatory guidelines (e.g. FDA EP JP)
- Thorough knowledge of microbiological test methods and environmental monitoring programs.
- Experience with LIMS.
- Experience in support/writing OOS/OOE/OOT and/or deviation investigation.
- Strong written and verbal communication skills.
- Detail-oriented with expertise in problem solving and solid decision-making abilities.
- Strong interpersonal skills.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $85400/yr and $158600/yr; 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.
Company will not sponsor visas for this position.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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 sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.
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 to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$85400.00 - $158600.00Skills 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
