Senior Scientist - Bioanalytical Outsourcing

10+ years

Not Disclosed

Lexington

10 Jan. 8, 2025

Job Description

Job Type: Full Time Education: BS/BA/PhD 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 Scientist, Bioanalytical Sciences Outsourcing

Location: Greater Boston Area
Department: siRNA Nonclinical Development, Novo Nordisk

About the Department

Novo Nordisk's Greater Boston Research & Development hub brings together a collaborative and innovative team dedicated to advancing life sciences. We operate across Lexington, Watertown, and Cambridge, managing the full spectrum of R&D from early research to late-stage clinical development. Our team drives cutting-edge research and focuses on therapeutic areas such as diabetes, obesity, and MASH treatment. The culture we foster is one of fun, ingenuity, and innovation, supported by competitive compensation packages and a healthy work-life balance.

The Position

The Senior Scientist for Bioanalytical Sciences Outsourcing will play a key role in managing the outsourcing of PK, biomarker, and ADA assays to Contract Research Organizations (CROs). The position will work extensively within a multi-disciplinary team at Novo Nordisk and will serve as the bioanalytical assays subject matter expert, supporting RNAi technology platforms. The role requires in-depth knowledge of bioanalytical assays and their application to nonclinical and early-stage clinical studies.

Key Responsibilities

Outsourcing Management

Lead the outsourcing of bioanalytical assays for PK, biomarker, and ADA to CROs.
Identify suitable CROs and set up contracts for assay validation.
Support nonclinical studies and clinical trial sample analysis, ensuring smooth transfer and cross-validation of assays between Novo Nordisk and external partners.
Act as the subject matter expert for the application of bioanalytical assays (LC-MS, MSD, ELISA, qPCR, cell-based assays) to support study objectives.

Cross-Functional Collaboration

Participate in routine vendor meetings, supply critical reagents, assess study plans, negotiate data transfer agreements, and review data and reports.
Engage in the creation and review of regulatory documents for clinical trials (e.g., IND, CTA) and drug approvals (e.g., NDA, MAA).
Attend program team meetings, ensuring study timelines are met and providing bioanalytical support to advance programs.
Communicate effectively with teams across organizational levels and functions to ensure project success.

Leadership and Mentorship

Act as a cooperative and dependable bioanalytical representative within the team.
Collaborate with colleagues across Novo Nordisk's R&D organization and external partners to ensure the successful execution of studies.

Qualifications

Required

Master’s degree with at least 8 years of relevant academic or industry experience, or PhD with 4 years of industry or post-doctorate experience, or BS/BA with at least 10 years of technical experience in bioanalytical assays.
At least 8+ years of experience in bioanalytical assays (e.g., immunoassays, LC-MS/MS, HPLC) in the pharmaceutical industry.
Experience in outsourcing management for nonclinical and clinical studies.
Familiarity with regulatory guidelines, GLP/GCP principles, and the creation of regulatory documentation for clinical trials.

Preferred

Experience with nucleic acids (e.g., siRNA, ASO, gene therapy) preferred.
Proven ability to handle multiple priorities and meet aggressive deadlines.
Strong verbal and written communication skills, with the ability to effectively present findings and lead discussions.

Equal Opportunity Employer

Novo Nordisk is an equal opportunity employer, dedicated to fostering an inclusive culture that celebrates diversity. We are committed to providing equal employment opportunities to individuals regardless of race, ethnicity, gender, religion, disability, or any other characteristic protected by law.

If you require accommodation to apply for this role, please contact us at 1-855-411-5290.

Apply Now: Novo Nordisk Careers

Together, we’re life-changing.

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kannur | Kochi | Malappuram | Thiruvananthapuram |

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Boulder | Denver | Westminster |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | United States |

United States :

Hawai | Sylmar |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Latvia | Leuven | Poland | Spain |

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

North Brabant :

Breda |

South Holland :

Leiden |

Pharma Jobs in Australia

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in United Kingdom

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Surrey :

Pirbright |

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

Buenos Aires :

Buenos Aires |

Austria :

Austria |

Vienna :

Vienna |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

South Yorkshire :

Sheffield |

United Kingdom :

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Lyon | Paris |

Attica :

Athens | Koropi |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

Midrand |

Brazil :

Sao paulo |

South America :

Argentina |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |

Senior Scientist - Bioanalytical Outsourcing

Job Description

Job Title: Senior Scientist, Bioanalytical Sciences Outsourcing

About the Department

The Position

Key Responsibilities

Outsourcing Management

Cross-Functional Collaboration

Leadership and Mentorship

Qualifications

Required

Preferred

Equal Opportunity Employer

Latest Jobs

Senior Safety Medical Writer

Principal Scientist - Mathematical Modeling Of Microphysiological Systems

Scientist - Microphysiological Systems - Cardiometabolic Disease

Principal Scientist - Translational Medicine

Director - Safety Surveillance

Associate Director - Global Regulatory Lead

Director - Global Regulatory Lead

Global Safety Lead

Senior Clinical Pharmacology Specialist

Head Of Patient Safety - North America Operations