Senior Expert – Process Analytics

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Job Description Summary

The Senior Expert – Process Analytics designs, plans, performs experiments, interprets and reports results of scientific experiments for the preparation and timely delivery of drug substances (DS) and drug products (DP) for various programs and process improvements.

Job Description

#LI-Onsite

Key Responsibilities:

• Lead and manage projects, support/coach team members, participate in sub-teams and contribute to overall Technical Research & Development (TRD) strategies and goals
• Executes and documents experimental procedures in support of process development activities as well as supporting investigational, clinical and commercial gene therapy programs
• Performs routine testing of samples by ddPCR, qPCR, HPLC, ELISA, AUC and other analytical methods
• Designs and performs lab experiments with minimal guidance
• Acts as the analytical technical lead for one or more projects
• Represent Process Analytics and work collaboratively within cross-functional and multidisciplinary teams
• Authors or reviews experimental protocols/reports and support regulatory submission documents related to analytical testing
• Leads assay troubleshooting and projects to improve method performance across network. Also participates in exploratory assay development efforts to support onboarding of new analytical technologies or assays
• Assists in responses to agency questions related to analytical methods/specification
• Executes experiments and analyze acquired data that contribute to development, optimization of assays to support pipeline or platform projects
• Maintains good documentation practices and accurate records of experiments
• Mentors and trains other scientists
• Other related job duties as assigned

Essential Requirements:

• BS in relevant scientific discipline with 8 years of experience; MS with 6 years of experience; Ph.D. with 3 years biopharmaceutical experience
• Experience in gene/cell therapy field required, experience with AAV and LVV a plus
• Strong critical thinking and problem-solving skills.
• Experience with various analytical methods used within cell and gene therapy as well as method development and troubleshooting
• An excellent and persuasive communicator
• Energetic, flexible, collaborative and proactive
• Strong communication, scientific writing and presentation skills
• Advanced molecular biology and analytical chemistry knowledge and techniques
• Understanding of GMP requirements and regulations a plus

The salary for this position is expected to range between $114,100 and $211,900 per year.

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.

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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to [email protected] or 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.

Salary Range

$114,100.00 – $211,900.00

Skills Desired

Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model
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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.