Senior Expert Science Technology Analytical Project Lead
Senior Expert Science Technology Analytical Project Lead
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Job Description
Job Description Summary
The Analytical Development Operations (ADO) group is responsible for developing analytical technologies and applying them to support viral vector development for cell and gene therapies. ADO supports chemistry manufacturing and control (CMC) activities from the earliest stages of product candidacy through commercial licensure. Within ADO the Senior Expert Science & Technology Analytical Project Lead (APL) APL is responsible for identifying critical quality attributes (CQA) of a viral vector candidate and developing analytical strategies and methods for monitoring CQAs throughout product development. The APL works within a cross functional CMC team to design coordinate and execute studies that demonstrate Novartis understands and appropriately controls the quality of our product and process. This APL position offers the opportunity to develop and apply rapidly advancing analytical technologies necessary to ensure Novartis consistently delivers safe and effective cell and gene therapeutics.Job Description
#LIHybrid
Key Responsibilities:
- Produce product CQA assessment analytical strategy specifications and comparability strategies/criteria
- Lead the development qualification transfer and validation of analytical methods among multiple internal and external analytical laboratories
- Facilitate forecasting and allocation of internal analytical resources
- Manage scope timelines and budget activities with external analytical laboratories
- Lead crossfunctional and crosssite product characterization and investigations
- Provide technical expertise and leadership as you collaborate within and across crossfunctional teams to support process development and establish control strategy
- Provide strategic recommendations across the network
- Serve as a key scientific and technical representative on crossfunctional teams (CMC Regulatory Quality Manufacturing etc.
- Write review and/or approve experimental protocols/reports and regulatory submissions
- Respond to questions from regulatory authorities regarding analytical topics and specifications
Essential Requirements:
- BS/BA in relevant field with 8 years MS with 6 years or Ph.D. with 4 years experience in biopharmaceutical industry
- A critical thinking mindset problemsolving skills and the interpersonal communication scientific writing and presentation abilities to provide effective leadership
- Strong organizational skills and ability to prioritize simultaneous projects and activities
- Proven ability to effectively lead and participate on teams often via tele/video conference
- Passion for continuous learning and capability to work in a highly dynamic fastpaced collaborative environment is key to the success of this role.
- Experience with analytical support for biologic product commercialization especially in cell/gene therapy field
- Strong background in protein/nucleic acid chemistry/biochemistry/analytical chemistry
- Experience preparing regulatory filings and other correspondence/interactions with regulatory agencies
Desirable Experience:
- Project management experience
- Familiarity with GMP practices and requirements (e.g. change control) and regulations (FDA/EMA/ICH etc.
The pay range for this position at commencement of employment is expected to be between $114100 and $211900/year; however while salary ranges are effective from 1/1/25 through 12/31/2025 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a signon bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart passionate people like you. Collaborating supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: 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 email to or calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$114100.00 $211900.00Skills 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 ModelRequired Experience:
Senior IC
Employment Type
Full-Time
