Summary
About the Role
Major accountabilities:
Provide strategic, technical and scientific leadership to the gene therapy analytical development bioassay team, to develop, optimize, and characterize robust analytical methods and new technology evaluation and implementation.
Understand and characterize product critical quality attributes and develop assays to monitor and control these attributes
Collaborate closely with peer function teams and communicate complex technical topics and decisions within the department and to program teams. Provide effective technical and business leadership at the R&D-CMC interface.
Ensure seamless transition of analytical capabilities from development to a GMP laboratory.
Work collaboratively with process development leadership to develop and/or analytical platforms to support company’s multi-product portfolio of development programs.
Provide strategic leadership and influence for the development and tech transfer of analytical methods to support manufacturing of gene therapy products across a network of internal and external manufacturing sites.
Develop, lead and coach a group of engineers/scientists through direct supervision and/or as matrix leader.
Author and review regulatory submissions and responses to questions from health authorities.
Requirement:
PhD or equivalent in Biology, Biochemistry, Bioengineering or related scientific discipline.
Minimum 5 years of relevant industry experience in analytical development for biological, preferably cell and gene therapy products is required.
Strong fundamental knowledge of cell biology, immunology and existing analytical technology is expected. Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities.
Demonstrated experience leading analytical development initiatives in support of cell or gene therapies, or protein biologics manufacturing, early- and late-stage.
Proficiency in strategic planning, team dynamic management, and technical leadership.
Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a fast-paced environment.
Expertise in binding, cell-based assays and other plate-based assays using variety of platforms including ELISA, MSD, high-content imaging and luminescent/fluorescent plate reader, methods development, drug substance and drug product.
Demonstrated ability to influence scientific and business strategies and decisions via collaboration, communication, team building, creative thinking, and strong organizational skills are required.
The pay range for this position at commencement of employment is expected to be between $166,400 & $249,60/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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 sign-on 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 “at-will 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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: 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 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 are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
