Healthcare Businesswomen’s Association
Senior Expert Science & Technology, Analytical Development
Healthcare Businesswomen’s Association, East Hanover, New Jersey, us, 07936
Job Description Summary
Internal Posting Title: Senior Expert Science & Technology
Position is onsite in East Hanover, NJ
Bench to bedside! This exciting role serves as a Senior Expert Science & Technology to develop, optimize, and implement novel analytical methodologies for our CAR-T cell therapy products. The successful candidate will work with a talented and experienced team in our Technical Research and Development organization at East Hanover, New Jersey. The successful candidate will own and drive technical and development projects designed to test and characterize cell therapy products through an assortment of analytical methods. This role will also contribute to cross-functional activities including supporting process development, process characterization, product characterization, and method implementation in Quality Control Units. This position requires strong scientific leadership skills and a deep understanding of method suitability for Quality Control implementation. This individual will uphold Novartis Values & Beliefs and Code of Ethics to successfully support our bold mission of delivering effective CAR-T cell products for patients in need.
Job Description
Your responsibilities will include, but are not limited to:
Independently design and develop complex cellular characterization and potency assays for cell therapy products.
Lead, own, and drive method qualification, optimization, transfer, and implementation activities, along with the relevant project-specific sub-teams.
Actively keep abreast of the latest advances in next-generation analytical technologies for cell therapies.
Record and maintain meticulous records in electronic laboratory notebook in compliance with GLP/GMP standards.
Continually identify areas for improvement with tangible solutions and implementation approaches.
Knowledge of appropriate GMP/GLP quality systems.
Support tracking and trending systems, and programs, which assist in the testing, evaluation, and monitoring of quality and efficiency.
Author and review technical and regulatory documents to ensure completeness, accuracy, consistency, and clarity.
Requirements:
BS, MS or Ph.D in biology, chemistry, biochemistry, immunology or other related science.
8+ (BS), 5+ (MS) or 3+ (Ph.D) years of industry experience in assay development in cell and gene therapy field.
Understanding of the scientific principles underpinning cellular-based analytical methods including ELISA, MSD, and Cell-based assays.
Expertise with aseptic technique and mammalian cell culture, Human T-cell culture experience is required.
Ability to present complex data and communicate clearly with a variety of cross-functional teams.
Detail-oriented with expertise in problem solving and solid decision-making abilities.
Established ability to work in a regulated environment.
Good presentation skills and scientific/technical writing skills.
Desired Requirement:
Experience writing laboratory SOPs and technical instructions is preferred.
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?
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.
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.
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between $124,000-$186,000; however, 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.
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.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives.
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
Salary Range:
$124,000.00 - $186,000.00
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 Project Management
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Internal Posting Title: Senior Expert Science & Technology
Position is onsite in East Hanover, NJ
Bench to bedside! This exciting role serves as a Senior Expert Science & Technology to develop, optimize, and implement novel analytical methodologies for our CAR-T cell therapy products. The successful candidate will work with a talented and experienced team in our Technical Research and Development organization at East Hanover, New Jersey. The successful candidate will own and drive technical and development projects designed to test and characterize cell therapy products through an assortment of analytical methods. This role will also contribute to cross-functional activities including supporting process development, process characterization, product characterization, and method implementation in Quality Control Units. This position requires strong scientific leadership skills and a deep understanding of method suitability for Quality Control implementation. This individual will uphold Novartis Values & Beliefs and Code of Ethics to successfully support our bold mission of delivering effective CAR-T cell products for patients in need.
Job Description
Your responsibilities will include, but are not limited to:
Independently design and develop complex cellular characterization and potency assays for cell therapy products.
Lead, own, and drive method qualification, optimization, transfer, and implementation activities, along with the relevant project-specific sub-teams.
Actively keep abreast of the latest advances in next-generation analytical technologies for cell therapies.
Record and maintain meticulous records in electronic laboratory notebook in compliance with GLP/GMP standards.
Continually identify areas for improvement with tangible solutions and implementation approaches.
Knowledge of appropriate GMP/GLP quality systems.
Support tracking and trending systems, and programs, which assist in the testing, evaluation, and monitoring of quality and efficiency.
Author and review technical and regulatory documents to ensure completeness, accuracy, consistency, and clarity.
Requirements:
BS, MS or Ph.D in biology, chemistry, biochemistry, immunology or other related science.
8+ (BS), 5+ (MS) or 3+ (Ph.D) years of industry experience in assay development in cell and gene therapy field.
Understanding of the scientific principles underpinning cellular-based analytical methods including ELISA, MSD, and Cell-based assays.
Expertise with aseptic technique and mammalian cell culture, Human T-cell culture experience is required.
Ability to present complex data and communicate clearly with a variety of cross-functional teams.
Detail-oriented with expertise in problem solving and solid decision-making abilities.
Established ability to work in a regulated environment.
Good presentation skills and scientific/technical writing skills.
Desired Requirement:
Experience writing laboratory SOPs and technical instructions is preferred.
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?
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.
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.
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between $124,000-$186,000; however, 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.
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.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives.
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
Salary Range:
$124,000.00 - $186,000.00
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 Project Management
#J-18808-Ljbffr