Novartis

Investigator

Business Unit

Translational Medicine

Country

USA

Work Location

East Hanover, NJ

Company/Legal Entity

Novartis Pharmaceuticals

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Job Description

Department overview
The global PK Sciences (PKS) department has major contributions to drug discovery and development within Novartis and is divided geographically with several groups in Europe, North America and Asia. Our main task is the evaluation of pharmacokinetic and pharmacodynamic aspects of new molecular entities throughout the entire drug development value chain. For this the department relies on various disciplines with expertise in project management, (pre)clinical pharmacokinetics, bioanalysis, drug metabolism and isotope synthesis.

Job Description
As part of an integrated team, the successful candidate will be responsible for method development and validation of LC-MS/MS quantitative assay and sample analysis for small and large molecule drug candidates in biological samples supporting nonclinical toxicokinetics in preclinical species and clinical studies in humans. This includes the preparation of method validation, toxicokinetic and bioanalytical data reports, and calculation of toxicokinetic and pharmacokinetic parameters. The position requires an individual to be capable of using multiple instrument software programs and a laboratory information management system (LIMS) for the calibration and quantitation of raw data, and standard word processing and spreadsheet applications. The candidate will also spend a significant portion of their time on new initiatives such as surface sampling and MS imaging. The candidate should understand key principles underlying relevant technologies and protocols in own discipline and closely related areas.

 

Key Activities
•Responsible for conducting all bioanalytical work with respect to scientific integrity, quality, and timelines.

•Establishment, troubleshooting and performing of advanced method development, validation and sample analysis in pre-clinical studies.

•Work with key stakeholders to execute Bioanalytical preclinical strategy and ensure performance metrics are maintained.
•In collaboration with the QA department, conduct GLP site audits and qualification activities as a Subject Matter Expert in bioanalytics, toxicokinetics and pharmcokinetics.
•Monitoring and review of Toxicokinetic studies and reports in support of IND enabling activities.
•Collaborate effectively and efficiently with internal customers and external providers in order to establish good working relationships while ensuring high quality deliverables.

EEO Statement

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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Minimum requirements

M.S. in Chemistry, Organic Chemistry, Biochemistry or related field with a minimum of three years or B.S. with five years of relevant industrial experience.

Experience in a GLP laboratory environment, proficiency with electronic laboratory notebook, Watson LIMS, Phoenix WinNonlin, Microsoft office product suite, as well as excellent oral and written communication skills are desirable.

An excellent working knowledge of general laboratory techniques, HPLC and LC-MS/MS operation, and troubleshooting and method development is essential. A strong background in bioanalytical problem solving is also required.

Good IT skills with the ability to write basic scripts or macros is desirable.
Good attention to detail, an analytical investigative and questioning nature, with an innovative solution-oriented approach.

Well developed interpersonal skills with good presence; experienced presenter and communicator.

A self-starting and decisive individual; open, confident and persuasive, succeeding through influence.

Good planning, prioritisation, problem solving,organisational and multi-tasking skills.

Resilient, energetic and enthusiastic; responding constructively to challenging new ideas and inputs.

Team player, ability to be flexible and adapt to a changing environment.