Senior Analytical Development Specialist
4 days ago
As a key member of our team, you will play a crucial role in supporting developmental activities to deliver gene therapy to patients. You will be responsible for technical and development projects designed to characterize gene therapy products through various chromatographic and biophysical-based analytical methods.
Key Responsibilities:- Contribute to project strategy and drive implementation; apply scientific/technical/GMP and/or quality-related expertise to address complex R&D issues within a multifunctional project team.
- Coach team members and contribute to global technical strategies and goals; maintain and qualify equipment/infrastructure and manage operational aspects in the lab as assigned.
- Design, plan, perform, interpret, and report scientific experiments or GMP testing or pilot plant processes for the preparation and timely delivery of drug substances (DS), drug products (DP), processes, or procedures.
- Design, plan, and perform product characterization studies using chromatography (HPLC), Capillary electrophoresis (CE), mass spectrometry (MS) based, and other biophysical assays for the characterization and lot release/stability monitoring of gene therapy products. Identify, develop, validate, and implement novel analytical assays and new GMP-compliant methodologies for pipeline gene therapy products.
- Drive project timelines and deliverables while meeting internal quality and data integrity requirements.
- Implement resolution to technical challenges, communicate effectively, and present complex data within the department and cross-functionally.
- Author and/or review method development reports, SOPs, validation reports, and technical documents for regulatory filings.
- Actively contribute to analytical development for clinical and commercial manufacturing and assist in advancing science-driven and innovative methodologies.
- Independently identify new scientific technologies and instrumentation with the potential to improve development workflows. Actively keep ahead of the latest advances in analytical technologies for cell and gene therapy.
- Bachelor's degree in Analytical Chemistry, Biology, Biochemistry, Molecular Biology, Immunology, or related scientific discipline with > 4 years of prior experience in industry required. BS with > 5 years, MS with > 3 years, and Ph.D. with 0-2 years experience preferred.
- State-of-the-art principles and theories in analytical chemistry, protein chemistry, DNA chemistry, and related disciplines.
- Strong scientific background and understanding of gene therapy, cell biology, and drug product development.
- Strong working knowledge on analytical software including but not limited to Chromeleon, Empower, Chemstation, Astra, 32Karat, Xcalibur, Mascot, Byonic.
- Demonstrated ability to work collaboratively in a fast-paced team environment and quickly acquire new technical skills and knowledge.
- Drives innovation by researching relevant literature to improve existing methodologies while evaluating alternative approaches.
- Excellent organizational, communication, and scientific/technical writing skills and experience working with AAV, LVV analytics preferred.
We are the Novartis Group of Companies, committed to building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds, and perspectives. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
We offer a total compensation package for this position, which includes a salary range of $102,400 - $153,600 per year, a sign-on bonus, restricted stock units, and discretionary awards, in addition to a full range of medical, financial, and/or other benefits. Further details will be provided if an employee receives an offer of employment.
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