Job Description Summary
Internal Title: Expert, Science & Technology
Position is on-site in East Hanover, NJ
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About the role:
Novartis expands its early development and innovative CAR-T cell therapy manufacturing capabilities in its newly launched Center of Excellence, located in the East Hanover, NJ campus. Our therapies are being developed as transformative treatments with life-saving potential for various B cell malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.
Under general direction, the Expert, Science & Technology associate will 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.
Your Key Responsibilities:
- This is a Monday-Friday 12pm-8pm shift position with rotations on the weekend. Shift will be fixed according to business needs.
- Perform micro and EM testing in support of clinical release strategies and 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.
- Perform laboratory/equipment cleaning as per applicable schedules and procedures and ensure cleanliness of laboratory working areas.
- 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.
- Support execution of method qualification/development & optimization/transfer as governed by protocols and/or under minimal supervision.
- Train other associates in specific areas of competency.
- Support/manage shipments and communications to external testing sites and support laboratory management in drafting analytical response/strategy documents.
- Prepare presentations as required.
- Identify and execute process improvements, lead and/or contribute to writing CAPAs/OOS/OOE/OOT and perform deviation investigations.
- Support change control as required, support internal and external audits of facilities, follow GxP quality policies and procedures and drive 5S and Lean Lab projects.
- Assist equipment and metrology teams in troubleshooting equipment issues, working knowledge of LabWare, LIMS and/or other QC data systems.
- Ensure all assigned training is completed within the required time frame.
- Greater exposure and knowledge of internal and external guidance, good compliance in appropriate GMP quality systems (e.g., ESOPs, Subway, Trackwise, BMRAM, 1QEM and CONDOR etc.).
- Coordinate cross-functional activities, serves as a QC/Micro representative in cross-functional teams.
- Perform other job duties as assigned.
Role Requirements:
- Bachelor's degree in biology, chemistry, biochemistry, microbiology or other related science. MS is preferred.
- Minimum of 3 years of relevant experience in one of the following 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.
Desired Requirements:
- Gowning Qualified
- Environmental monitoring and qualification of cleanrooms
- Knowledge of Microbiology Test methods including but not limited to Sterility, Growth Promotion, Microbial Identification and Endotoxin testing
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?
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally.
Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams, representative of the patients and communities we serve, and 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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com 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.
Salary Range: $84,000.00 - $126,000.00
Skills Desired: Audit Management, Business Partnerships, Change Controls, 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, Speed and Agility Training, Standard Operating Procedure (SOP), Technical Knowledge
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