Expert/Senior* Expert Gene Therapy Analytical Development - Bioassay

U014 (FCRS = US014) Novartis Pharmaceuticals Corporation; East Hanover (NJ); On-site; USD 120,000 - 222,000; Full time

Job summary

Novartis Pharmaceuticals Corporation in East Hanover seeks an Analytical Development Bioassay specialist to support gene therapy programs. You will develop/validate assays (ELISA, MSD, PCR) and characterize products for DS/DP, applying GMP standards across diverse platforms.

You will collaborate with cross-functional teams, coach staff, and drive timelines. A strong biology/immunology background and excellent communication are essential.

Qualifications

• Bachelor's degree in biology, biochemistry, molecular biology, immunology or related field with industry experience.
• Experience developing/validating cell-based and plate-based assays (PCR, ELISA, flow cytometry, MSD).
• Strong understanding of gene therapy and drug product development.
• Able to work in a fast-paced team and communicate complex data.
• Experience with AAV/LVV analytics preferred.
• Strong writing and documentation skills.

Responsibilities

• Contribute to project/network strategy and drive implementation with GMP/quality expertise to address complex R&D issues within a multifunctional project team.
• Coach team members and manage lab equipment/infrastructure; maintain/qualify lab infrastructure.
• Design, plan, perform, interpret and report scientific experiments or GMP testing for DS/DP.
• Develop and validate novel analytical assays for pipeline gene therapy products.
• Drive project timelines and ensure data integrity; present data cross-functionally.
• Author/review method development reports, SOPs, validation reports for regulatory filings.
• Advance analytical development for clinical and commercial manufacturing.
• Identify new scientific technologies to improve workflows and stay ahead of advances in analytical methods.
• Follow GMP/GLP regulations and Novartis SOPs; other duties as assigned.

Skills

Analytical method development

Flow cytometry

PCR

ELISA

MSD

Gene therapy

Data analysis

Scientific writing

Team collaboration

GMP/GLP

Education

Bachelor's degree in biology/biochemistry/molecular biology/immunology or related field

Tools

MSD platform

High-content imaging system

Plate reader (luminescent/fluorescent)

Job description

Band Level 4 Job Description Summary

As a key member of the Analytical Development Bioassay team, this individual will support developmental activities to aid in delivering gene therapy to patients. The successful candidate will support technical and development projects designed to characterize gene therapy products through an assortment of analytical methods. This role will also contribute to cross-functional activities including monitoring and characterizing of processes and products to identify opportunities for continuous improvement. Growth mentality and passion to serve patients, his/her technical team and development programs is a must.

This role is based in East Hanover. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.

What you will be doing

• Contribute to all project/network strategy and drive the implementation; apply scientific/technical/ GMP and/or quality-related expertise to address complex R&D issues within a multifunctional project team.
• Work with/coach team members and contribute to global technical strategies and goals; maintain and qualify equipment/infrastructure and manage operational aspects in 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 cell-based assays and other plate-based assays using variety of platforms including ELISA, MSD, high-content imaging and luminescent/fluorescent plate reader 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 ahead of the latest advances in analytical technologies for cell and gene therapy.
• Work according to appropriate GMP/GLP regulations and Novartis SOPs/Guidelines and Code of Conduct.
• Other related job duties as assigned.

What you will bring to the role

• For Expert level: Bachelor's degree in biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline with > 2 years of prior industry experience required. BS with > 5 years, MS with >2 years, Ph.D. with >1 year experience preferred.
• For Sr. Expert level: Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline with > 4 years of prior experience in industry required. BS with > 5 years, MS with > 4 years and Ph.D. with > 3 years experience preferred.
• Established experience with analytical method development and validation for cell-based assays and other plate-based assays using variety of platforms including PCR, ELISA, flow cytometry, MSD, high-content imaging and luminescent/fluorescent plate reader.
• Strong scientific background and understanding of gene therapy, cell biology and drug product development.
• 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.
• Facilitates the incorporation of ideas from conferences or literature into work processes.
• Experience working with AAV, LVV analytics preferred.
• Knowledge of using AI in daily activities is a plus.
• *This is a dual level posting, and candidate will be assessed for both levels based on their knowledge and experience.

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role at Expert and Senior Expert levels:
Expert (level 3) $93,800.00 - 134,000.00 - 174,200.00
Senior Expert (level 4) $119,700.00 - 171,000.00 - 222,300.00

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. 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 strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$119,700.00 - $222,300.00

Skills Desired

Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Curious Mindset, Data Analysis, Detail-Oriented, Drug Development, Ethics, Gene Therapy, Immunology, Inventory Management, Machine Learning (ML), Medical Research, Molecular Biology, Python (Programming Language), Science

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

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