Description
Job Description
1 purpose! Novartis expands its early development and innovative CAR-T cell therapy capabilities for making personalized medicine accessible to more patients in need. Our therapies are being developed as transformative treatments with life-saving potential for various hematological 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 Associate Expert, Science & Technology will direct and assist in functions supporting QC Micro/EM.
Your responsibilities will include, but are not limited to:
Shift Position: Monday - Friday, 8am - 4pm with alternating weekend coverage to support business needs.
* Perform micro/EM testing such as environmental monitoring, gram stain, sterility, endotoxin, and mycoplasma.
* Perform all testing and activities compliantly following appropriate SOPs and procedures.
* Executes and follows SOPs and quality policies.
* Collects and generates data for trend reporting
* Monthly review of laboratory logbooks and monthly laboratory cleaning..
* Manage reagent and equipment inventory for assigned areas of responsibilities
* Maintain controls and reference standards to support testing.
* Maintain input to keep LIMS current
* Verify the accuracy of data generated
* Review/approve data generated by other team members.
* Contributes to assigned projects by following pre-defined tasks and executing as instruct-ed.
* Contributes to the gowning qualification program by taking samples and analyzes and generates data.
* Identify process improvements
* Execute method qualification/optimization of methods.
* Contributes to investigations by partnering with Scientist and/or Senior Scientist.
* Participate in OOS/OOE investigation
* Participate in deviation investigation/CAPA implementation in a timely manner
* Support 5S and Lean projects.
* Interface with regulatory agencies during audits.
* Knowledge of LabWare LIMS and/or other QC data systems.
* Knowledge of appropriate GMP/GLP quality systems (eSOPs, TEDI, etc).
* Plan and schedule activities.
Diversity & Inclusion / EEO
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.
Minimum Requirements
What You'll Bring to the Role:
* BA or MS or advanced degree in biology, chemistry, biochemistry, microbiology or other related science or equivalent work experience.
* 1+ years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
* Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e. ANSI, ISO, etc.).
* Thorough knowledge of microbiological and environmental monitoring, test methods.
* Micro/Environmental knowledge to facilitate investigations.
* Knowledge of LIMS systems.
* Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations.
* Detail-oriented with expertise in problem solving and solid decision making abilities.
* Strong interpersonal skills which include a professional demeanor when interacting with Novartis personnel.
* Sound, practical and appropriate regulations with regards to Novartis
* Strong written and verbal communication skills are essential.
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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 [email protected] call +1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Division
Global Drug Development
Business Unit
TECHNICAL R & D GDD
Location
USA
Site
East Hanover, NJ
Company / Legal Entity
Novartis Pharmaceuticals
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
Yes
