Jul 25, 2022

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

The organizational title for this role will be Senior Expert, Science & Technology. He/she/they will initiate, direct and execute the Development and optimization of cell-based potency and other functional bioassays in a team environment of phase-appropriate bioassays that are used for drug substance and drug product stability and lot release testing as well as characterization studies.

• Plan and execute experiments that contribute to bioassay development, optimization, qualification/validation of bioassays suitable for drug product stability studies and lot disposition.
• Optimize and troubleshoot cell-based assays as well as other plate-based assays using variety of platforms including but not limited to ELISA, MSD, high-content imaging and luminescent/fluorescent plate reader in support of developing release and characterization assays for gene therapy products.
• Participate (or lead) method qualification/validation in a cGMP setting and may be involved in the method transfer to internal and/or external QC laboratories. Support tech transfer of methods to internal QC group and/or CROs.
• Assist in authoring of technical reports and SOPs.
• Work with junior research associate on experimental design, troubleshooting, assay optimization and data interpretation as needed.
• Interpret and present data at group and department meetings.
• Collaborate within Bioassay group and provide support to collaborating functional groups as needed
• Monitors and evaluates completion of tasks and projects.
• Participate in exploratory assay development efforts to bring new technologies or assays to Analytical development
• Conducts work in compliance with cGMP, GDP, safety and regulatory requirements.
• Thoroughly analyzing data and ensuring the data quality. Provides analysis and evaluation of material and products at all stages of development process.
• Maintains broad knowledge of state-of-the-art principles and theories in Bioassay
• Makes major contributions to scientific literature and conferences.
• Serves as in-house and outside consultant.
• Interfaces with various departments.
• Other related job duties as assigned.

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:

• Bachelor's in Cell Biology, Molecular Biology or related discipline with 8 years experience or Master's with 6 years experience or PHD with 4 years experience.
• Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Expert knowledge of scientific principles and concepts; Reputation as emerging leader in field with sustained performance and accomplishment.
• Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• May determine methods and procedures on new assignments and may provide guidance to other lower level personnel.
• Experienced in cell-based assays as well as other plate-based assays using variety of platforms including but not limited to ELISA, MSD, high-content imaging and luminescent/fluorescent plate reader.
• Ability to work in a fast-paced team-orientated environment.
• Excellent written and verbal communication skills.
• Experience with analytical and/or statistical software (e.g., JMP, Softmax Pro, XLfit, Gen5 etc.), is highly beneficial.
• Familiarity with virology is a plus.

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 (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.
Global Drug Development
San Diego, CA
Research & Development
Full Time
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Senior Scientist, Analytical Development - Bioassay

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