Mar 18, 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 Senior Expert, Science & Technology - MolBio, Initiates, directs and executes the Development and optimization of phase-appropriate molecular biology assays for the lot release, stability testing and characterization of drug substance/drug product. Participate in exploratory studies driving the evaluation of state-of-the-art new technology platforms, and innovative upgrades for existing assay platforms.

Your responsibilities include, but are not limited to:

• Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems.
• Plans and executes laboratory research.
Initiates, directs and executes the development, optimization, qualification of robust molecular assays (i.e. NGS, qPCR, ddPCR and/or other molecular assay platforms) for DNA characteristics such as genomic integrity and residual packaged impurity DNA, suitable for the characterization and lot disposition of AAV-based gene products
• Conducts work in compliance with cGMP, safety and regulatory requirements.
• Participates in activities such as RNA isolation, cDNA library construction, library amplification, genomic DNA isolation, polymerase chain reaction, and other standard molecular biology techniques.
• Analyze data with applicable bioinformatics tools/scientifically sound interpretation and present data at group/departmental meetings.
• Able to troubleshoot experiments based on thorough understanding of assay principles
• Authoring of technical reports and SOPs associated with the molecular assays developed and qualified .
• Communicates and partners with cross-interdisciplinary teams to include, but not limited to engineering, regulatory compliance, scientists and other professionals
• Serve as SME of molecular assays in support of technology transfer of methods to internal QC group and/or CROs and subsequent trouble-shooting, as needed.
• May act as spokesperson on corporate research and development and advise top management.
• Collaborate within the Analytical Development-Molecular group and provide support to collaborating functional groups, as needed
• Work with junior research associates on experimental design, troubleshooting, assay optimization and data interpretation, if applicable.
• Maintains broad knowledge of state-of-the-art principles and theories.
• Participate in exploratory studies driving the evaluation of state-of-the-art new technology platforms, and innovative upgrades for existing assay platforms.
• Makes major contributions to scientific literature and conferences.
• 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.
• Knowledge and hands-on experience with various molecular biology analytical methods .For example, DNA/RNA isolation, primer design, end point PCR, qPCR, qRT-PCR, droplet digital PCR, Sanger sequencing, next-generation sequencing (NGS)
• Experience in various molecular biology and sequence analysis softwares. For example, Geneious, Applied Biosystems 7500, QuantaSoft
• GXP experience preferred, but not required
• Experience with bioinformatics programming (e.g., Python, R, etc.), is a plus
• Experience with analytical and/or statistical software (e.g., JMP, Softmax Pro, XLfit, Gen5 etc.), is highly beneficial
• Demonstrated proficiency in developing and optimizing molecular bioassays independently with limited guidance
• Demonstrated ability to work in a fast-paced, team-orientated environment with aggressive timelines
• Experience and understanding of phase-appropriate analytical assay development, qualification, and validation obtained from 1-2 years of experience in GxP environment is a significant plus, but not required
• 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 Expert, Science & Technology (Analytical Molecular Biology)

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