Bioanalytics Investigator, PK Sciences

Job description

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.

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.

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.

Minimum Req.
M.S. in Chemistry or Biochemistry or related field with a minimum of 5 years or B.S. with a minimum of 8 years of hands-on with HPLC and LC-MS/MS. The candidate should be capable of working independently under moderate supervision and should possess good writing and verbal communication skills. 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 analytical problem solving is also required. Proficiency with personal computer applications for word processing, spreadsheets and graphics are desirable.

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.
• Collaborate effectively and efficiently with internal customers and external providers in order to establish good working relationships while ensuring high quality deliverables.

Other Minimum Requirements
• Excellent presentation skills.
• Familiarity with digital system and 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, organizational 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.

Desired profile

Minimum requirements

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.