Mar 02, 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 Expert, Science & Technology (Analytical Process Development), is responsible for developing and optimizing phase-appropriate analytical assays used for testing and characterization of drug substance/drug product as well as in-process pool product quality attribute and concentration testing.

Your responsibilities will include, but are not limited to:

• Provides analytical testing support across the entire process (e.g. upstream, downstream, drug product) in support of exploratory studies targeted at developing, demonstrating and characterizing new technology platforms and innovative upgrades for existing platforms.
• Perform analytical method development, transfer and testing support in the TR&D laboratory
• Work with QC and/or Analytical Sciences group to transfer analytical methods into TR&D lab
• Perform in-process and drug substance/drug product assays.
• Design, perform, and guide lab experiments in support of AAV process development and process characterization studies using some of the following techniques: ddPCR, qPCR, ELISA, analytical ultracentrifugation, spectrophotometry, particle analysis, HPLC, CE, SDS-PAGE, and Western blot.
• Author experimental protocols/reports and related to analytical methods
• Participate in assay troubleshooting and method performance improvement projects
• Represent TR&D laboratory in cross-functional teams (QC, Analytical Sciences, Technical Development, Manufacturing Sciences and Technology, etc.)
• Collaborate with contract testing labs to ensure successful completion of testing projects
• Manage the use and maintenance of scientific equipment and instrumentation, computer systems
• Support test sample forecasting, submission, progress tracking, and results reporting
• Participate in exploratory assay development efforts to bring new technologies or assays to the Analytical Development department.
• 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 chemistry, analytical chemistry, molecular biology, biochemistry or a related technical field with 4 years experience or Master's with 2 or PHD with 0.
• Experience, with knowledge and hands-on experience with various analytical methods including but not limited to, ddPCR, qPCR, Western Blot, ELISA, MSD, ELISpot, Flow HPLC, Capillary Electrophoresis, Cytometry/FACS, Luminescence/Fluorescence plate-based assays, Immunofluorescence microscopy.
• Demonstrated proficiency in developing and optimizing assays independently with limited guidance by more senior scientists.
• Demonstrated ability to work in a fast-paced, team-orientated environment with aggressive timelines.
• Excellent written and verbal communication skills.
• Experience and understanding of phase-appropriate analytical assay development, qualification, and validation in GxP environments is preferred.
• Experience with analytical and/or statistical software (e.g., JMP, Softmax Pro, XLfit, Gen5 etc.), preferred.
• Ability to troubleshoot experiments based on thorough understanding of assay principles.

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
careers default image

Expert, Science & Technology (Analytical Process Development)

Apply to Job Access Job Account