Quality Control Scientist

Job Description Summary

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 Quality Control Scientist in an individual contributor role located in Morris Plains, NJ. The Quality Control Scientist will support patient throughput and compliance activities within the Quality department.

 

Job Description

Number of positions open: 3

Shifts Available:

Wed-Sat AM - 7:30am-6:00pm (1 position available)

Wed-Sat PM - 2:30pm-1:00am (1 position available)

Sun-Wed AM - 7:30am-6:00pm (1 position available)

Location: Morris Plains, NJ
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Your responsibilities include, but are not limited to:

Patient Throughput

• Execute in-process and release testing on batches including, but not limited to, flow cytometry, IFNg potency, ELISA, qPCR, cell count and viability, sterility, and endotoxin.
• Perform data review, generate Certificates of Analyses for release of final produce in accordance with company procedure
• Work with cross-functional stakeholders to meet company timelines

Project Management

• Helps maintain progress of projects

Compliance

• Ensures that all planned, executed, and documented activities are aligned with company and site objectives.
• Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.

Support of Quality partners

• Assists Quality Control, AS&T, and Quality Assurance in investigations of assay-related issues.
• Executes and supports transfer of analytical methods between AS&T-QC, to other Novartis sites, and to CMOs.
• Provides timely response to requests for support of manufacturing deviations, investigations and change requests.

Other

• Performs or supports other tasks related to Quality and site operations, as needed
• Performs evaluation of new and existing analytical methods being transferred to or from the site by utilizing a risk-based approach.
• Ability to lift 20lbs unassisted

What you’ll bring to the role:

Requirements (mandatory: every candidate who is considered must have the qualifications described here. A candidate without these qualifications will not be considered or presented to the hiring manager)

• A minimum of a BA/BS in biology, chemistry, biochemistry, microbiology or other related science is required.
• At least 3 years of experience within pharmaceuticals of related testing laboratory is required
• Experience in Analytical Quality Control, method development, or a technical support function is required
• Demonstrated knowledge and skills in multiple analytical techniques is required
• Ability to prioritize and execute multiple tasks simultaneously under tight deadlines
• Strong verbal and written technical communication skills
• Strong interpersonal skill
• Proficiency using MS Word, Excel, and MS project is required
• Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations.
• Detail-oriented with ability towards problem solving and solid decision-making abilities
• Strong written and verbal communication skills are essential

Desirable (not mandatory but are used to prioritize candidates who have described preferred qualifications but does not eliminate candidates from being considered)

• Understanding of ICH and FDA/EMEA GMP requirements
• Knowledge of cGMP, USP and FDA guidelines
• Knowledge of LIMS systems
• Knowledge of Quality Management Systems, such as Trackwise and 1QEM

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. Be