Senior Scientist, Quality Control Analytics (Wed-Sat)

365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.

The Senior Scientist, Quality Control Analytics will coordinate and execute all activities to ensure the timely testing and release of all samples, collaborate with team in the design and execution of validation and other major projects. Provide employees with training and resources to meet or exceed customer requirements. Monitor processes and products to identify opportunities for continuous improvement. Serve as the subject matter expert on specific areas and techniques and proactively provides education technical knowledge and skills to less experienced scientists.

**Shift Hours: Wednesday - Saturday / Day Shift / 4/10 hours***

Your responsibilities will include, but are not limited:

• Takes on non-standard duties (i.e. HS&E representative)
• Supports laboratory management in scheduling activities
• Supports laboratory management or leads in drafting analytical response/strategy documents.
• Drives designing and executing CAPA outcomes
• Supports external teams in qualifying new and/or replacement equipment within the la-boratory
• Assists and supervises equipment and metrology teams in troubleshooting equipment is-sues
• Executes and leads non-standard studies/projects as required
• Support internal and external audits of facility as a recognized SME.
• Support and manage tracking and trending systems, and programs which assist in the testing, evaluation and monitoring of quality, assay performance and efficiency. Train other associates in specific areas of competency.
• Perform Bioanalytical testing in support of clinical and commercial release strategies.
• Ensures cleanliness of laboratory working areas
• Drives 5S and Lean projects.
• Work on shifts covering daytime / evening and one or both weekend days.
• Document results within electronic and paper based systems accordingly.
• Draft under supervision protocols compliant with ICH and NVS expectations
• Performs other job duties as assigned.
• Follows GxP quality policies and procedures.
• Revise and/or create SOPs, forms, laboratory test records as required using appropriate electronic systems.
• Acts as liaison for other departments in support of non-standard testing regimes
• Execute and supervise peer review of analytical data and archiving in lab documentation systems.
• Mentors and supports junior staff members
• Drives execution of method qualification/development & optimization/transfer as governed by protocols and/or under the supervision of senior lab staff.
• Perform daily equipment startup, shutdown and equipment calibration/PQ (when re-quired)
• Ensure assigned analytical methods are ready to be performed when required including management of reagent and equipment inventory
• Contribute, supports and lead writing of OOS/OOE/OOT and deviation investigations.
• Draft presentations as required
• Ensures all assigned training is completed within required time frame.

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.

What you'll bring to the role:

• Thorough general knowledge of bioassay test methods (e.g. Elisa, Flow cytometry, qPCR, cell culture)
• Experience using LIMS systems
• Knowledge of ICH, Eur. Ph., USP and FDA and JP guidelines.
• SME level knowledge of a particular area of bioanalytical testing
• Experienced in writing OOS/OOE/OOT and/or deviation investigations
• Experience in supporting internal and/or external laboratory audits
• Thorough knowledge of cGxP expectations
• 5 years experience in the pharmaceutical/Biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory.
• BA or MS in Cell biology Immunology, Molecular biology, virology, biochemistry, microbiology or other related science. Advanced degree may be an advantage but not essential.
• Advanced experience in the use of computer-based systems and applications associated with bioanalytical testing
• Advanced written and verbal communication skills
• Knowledge of LIMS systems.

The pay range for this position at commencement of employment is expected to be between $88,000 and $132,200/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.

Why Novartis?
236 million lives were touched by Novartis medicines in 2022, 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 (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.

Operations

QUALITY

USA

Morris Plains, NJ

Novartis Pharmaceuticals

Quality

Full Time

Regular

No

No