Senior Expert Science & Technology, Analytical Development

Novartis

3-8 years

$114,100 - $211,900

Remote, USA

10 Jan. 31, 2025

Job Description

Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Expert Science & Technology – Analytical Development

Location: East Hanover, NJ (Onsite)
Job Type: Full-time
Application Deadline: February 4, 2025

Job Summary:

Novartis is seeking a Senior Expert in Science & Technology to support CAR-T cell therapy development by designing, optimizing, and implementing advanced analytical methodologies. This role will be based at our Technical Research and Development organization in East Hanover, NJ and will contribute to process development, characterization, and Quality Control implementation.

The ideal candidate will bring scientific leadership, expertise in cellular characterization assays, and experience working in a regulated environment (GMP/GLP).

Key Responsibilities:

Analytical Method Development & Implementation:

Independently design, develop, and optimize cellular characterization and potency assays for CAR-T cell therapy products.
Lead and drive method qualification, optimization, transfer, and implementation activities.
Ensure analytical methods meet suitability standards for Quality Control (QC) implementation.
Maintain accurate documentation in electronic laboratory notebooks (ELN) in compliance with GLP/GMP standards.

Innovation & Cross-functional Collaboration:

Stay up to date with emerging analytical technologies for cell therapies and apply innovative solutions.
Contribute to process development, characterization, and manufacturing support.
Participate in cross-functional activities, supporting regulatory filings and technical documentation.
Author and review technical reports, standard operating procedures (SOPs), and regulatory documents.

Quality, Compliance & Process Improvement:

Ensure compliance with GMP/GLP quality systems.
Identify areas for process improvement and implement practical solutions.
Support tracking and trending systems to evaluate quality and efficiency.

Qualifications & Experience:

Education & Industry Experience:

BS, MS, or Ph.D. in Biology, Chemistry, Biochemistry, Immunology, or a related field.
Industry experience in assay development for cell and gene therapy:
- 8+ years (BS)
- 5+ years (MS)
- 3+ years (Ph.D.)

Technical & Scientific Expertise:

Strong understanding of cell-based analytical methods (ELISA, MSD, and cell-based potency assays).
Expertise in mammalian cell culture and aseptic techniques.
Human T-cell culture experience is required.
Strong ability to present complex data and communicate scientific concepts.
Experience working in a regulated environment (GMP/GLP, Quality Control, compliance).

Preferred Experience:

Experience writing SOPs and technical instructions.
Strong problem-solving skills and decision-making abilities.
Effective collaboration with cross-functional teams in a fast-paced setting.

Skills & Competencies:

Analytical Method Development & Validation
Cell-based Assays (ELISA, MSD, Flow Cytometry, PCR)
GMP/GLP Compliance & Quality Control
Process Optimization & Manufacturing Support
Technical Writing & Regulatory Documentation
Laboratory Equipment & Safety
Coaching & Mentorship
Data Science & Experimental Design

Languages Required:

English (Fluent)

Why Join Novartis?

Innovative Science: Be part of cutting-edge CAR-T cell therapy research and development.
Professional Growth: Opportunities for career advancement and leadership in analytical development.
Global Impact: Work on life-changing therapies for patients in need.
Diverse & Inclusive Culture: Join a collaborative, supportive, and innovative work environment.

🚀 Help us transform medicine and make a difference in patients’ lives!

Compensation & Benefits:

💰 Salary Range: $114,100 - $211,900 (Final offer based on experience, skills, and location)
🎁 Additional Benefits:

Sign-on bonus (as applicable)
Restricted stock units & discretionary awards
Medical, dental, vision & 401(k) plans
Paid time off (vacation, sick leave, parental leave, etc.)

🔗 Learn more about Novartis Benefits & Rewards: Novartis Careers

Commitment to Diversity & Inclusion:

Novartis is an Equal Opportunity Employer dedicated to building diverse and inclusive teams. We encourage applications from individuals of all backgrounds, experiences, and abilities.

📢 Join our Talent Network: If this role isn't the right fit, stay updated on future career opportunities by signing up here: Novartis Talent Network

📌 Note: Visa sponsorship is not available for this position.

#Novartis #CAR-T #AnalyticalDevelopment #CellTherapy #GMP #Biotechnology #Immunology #CellCulture

Recommended Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Argentina | Peru |

Brazil :

Brazil | Sao paulo |

Attica :

Athens | Koropi |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Japan | Saitama |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

New Mexico | Ciudad de México |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Lyon | Paris |

South Africa :

South Africa | Midrand |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account