Responsibilities:
- Work as a lead bioinformatics scientist, both independently and as a member of cross-functional teams, to develop bioinformatics pipelines for cell and gene therapy products to enable deep understanding of the product, including (but not limited to) genome integrity, impurities, integration, and oncogenicity.
- Support next generation sequencing (NGS) method development and validation following ICH guidance.
- Support ad hoc NGS analysis with scientific judgement for product characteristics
- Support validation of developed bioinformatics pipelines to meet GMP testing requirements.
- Support responses to questions from the FDA and EMA in support of IND, BLA, and post-authorization commitments for cell and gene therapy products.
- Follow Novartis quality guidance to ensure the integrity and traceability of pipeline development and validation
- Support bioinformatics pipeline transfer, installation, testing, and maintenance in non-GMP and GMP environments.
- Work with IT and engineering teams on data flow and automation of NGS data analysis
- Produce high quality written documentation including study protocols, data analysis plans and reports.
- Refine algorithms and tools for sequencing data analysis and propose improvements.
- Communicating internally with other departments and externally with collaborators about technological capabilities and gap analysis.
- Support the wider R&D team with general bioinformatics needs.
Essential Requirements:
- PhD or equivalent in bioinformatics, computational biology, biostatistics, physics, engineering, mathematics, molecular biology, virology or related discipline.
- 3 years of relevant industry work experience is strongly preferred, but related experience in academic settings will be considered.
- Work with IT and engineering teams on data flow and automation of NGS data analysis.
- Strong domain knowledge in genomics, excellent programming skills, and deep experience with next-generation sequencing and analysis.
- Strong problem-solving skill, adaptive, curious, and willing and able to learn new technologies and skills, applying this learning to the cell and gene therapy field.
- Knowledgeable in applying AI to software and bioinformatics pipeline development is a plus.
- Strong oral and written communication skills, ability to work both independently and collaboratively, to manage multiple concurrent, fast-paced projects and to work with multidisciplinary teams.
Desired Requirements:
- Knowledgeable in applying AI to software and bioinformatics pipeline development is desired
- Experience in cell and gene therapy drug development, or related fields dealing with virus-cell interactions, is desired.
- Experience in single cell sequencing is desired.
The salary for this position is expected to range is $132,300-$245,700
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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