摘要
This 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.
About the Role
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 $85,400/yr and $158,600/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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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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 & 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 [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
