Souhrn
About the Role
Shift: (Sun-Wed 7am-5:30pm)
Location: Morris Plains, NJ
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Key Responsibilities:
Perform Bioanalytical testing in support of clinical and commercial release strategies.
Acts as liaison for other departments and/or external stakeholders in support of non-standard testing regimes
Execute and supervise peer review of analytical data.
Support and manage tracking and trending systems, and programs which assist in the testing, evaluation and monitoring of quality, assay performance and efficiency.
Drives execution of method qualification/development & optimization/transfer as governed by protocols and/or under the supervision of senior lab staff.
Contribute, supports and lead writing of change controls, OOS/OOE/OOT and deviation investigations.
Supports laboratory management in drafting analytical response/strategy documents.
Assists and supervises equipment and metrology teams in troubleshooting equipment issues
Revise and/or create SOPs, forms, laboratory test records as required using appropriate electronic systems.
Support internal and external audits of facility as a recognized SME.
Key performance indicators:
Flawlessly delivers quality results on time to all customers, internal and external.
Essential Requirements:
- Minimum of 5 years' experience in the Pharmaceutical/Biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory.
- Thorough knowledge of cGxP expectations
- Thorough general knowledge of bioassay test methods (e.g. Elisa, Flow cytometry, qPCR, cell culture)
- SME level knowledge of a particular area of bioanalytical testing
- Experienced in writing OOS/OOE/OOT, and/or deviation investigations
- Knowledge of LIMS systems.
- Experience in supporting internal and/or external laboratory audits
- Advanced written and verbal communication skills as well as advanced experience in the use of computer-based systems and applications associated with bioanalytical testing
Desirable Requirements:
- Knowledge of ICH, Eur. Ph., USP and FDA and JP guidelines preferred, but not necessary
- Experience writing change controls preferred, but not necessary
Languages:
- English.
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 and $146,400/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. 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’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patient and communities we serve.
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:
https://talentnetwork.novartis.com/network
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
EEO Statement:
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 & 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 [email protected] 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.
