Scientist, Quality Control (Wed - Sat 7am - 5:30pm)

　　Job ID

　　390554BR

　　Jan 22, 2024

　　USA

　　About the Role

　　Location: Onsite - Morris Plains, NJ

　　Shift: Wednesday - Saturday 7am - 5:30pm

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

　　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, 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

　　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.

　　Diversity & Inclusion / EEO

　　We 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

　　Novartis: e-mail [email protected] or call +1 (877)395-2339

　　Sandoz: e-mail [email protected] or call: +1-609-422-4098

　　Role Requirements

　　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 as well as strong interpersonal skill

　　• Detail-oriented with ability towards problem solving and solid decision-making abilities

　　• Strong written and verbal communication skills are essential as well as proficiency using MS Word, Excel, and MS project is required

　　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: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:

　　https://www.novartis.com/about/strategy/people-and-culture .

　　The pay range for this position at commencement of employment is expected to be between $97,600 - $146,400 salaried; 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. You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

　　You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

　　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.

　　Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool.

　　Division

　　Operations

　　Business Unit

　　QUALITY

　　Location

　　USA

　　Site

　　Morris Plains, NJ

　　Company / Legal Entity

　　Novartis Pharmaceuticals

　　Functional Area

　　Quality

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　Yes