GCP Bioanalysis Senior Scientist

vor 20 Stunden

Basel, Schweiz Novartis Farmacéutica Vollzeit

We are looking for a GCP Bioanalysis Senior Scientist in the Translational Medicine Drug Disposition Bioanalytical group. The role involves using bioanalytical knowledge and lab/instrument skills to develop, validate, and analyze clinical samples for the company's novel modality biologics portfolio. Responsibilities include independently designing and validating assays, performing sample analysis, processing data, and evaluating results. As Senior Scientist you will also contribute to health authority documents, maintain lab equipment and records, and mentor team members. The ideal candidate has a college/university degree in biological sciences, experience in regulated biologics bioanalysis, proficiency in various biological techniques, and the ability to work independently and meet deadlines.

About the Role

In the Senior Scientist role, you will use your knowledge of bioanalytics and lab/instrument skills to develop, validate and analyze clinical samples focusing on our novel modality biologics portfolio.

Key responsibilities:

  • Independently designing, developing, and validating assays, and performing sample analysis using biological techniques for PK, PD and immunogenicity following SOPs and guidelines.
  • Being responsible for all assigned study/lab/project activities, and providing input to bioanalytical strategies.
  • Data processing, evaluating results, interpreting data, and drawing relevant conclusions. Critically analyzing data on study and project levels.
  • Conducting lab activities and keeping timely raw data records in accordance with company and health authority guidelines.
  • Preparing study protocols, reports, and contributing to health authority documents.
  • Maintaining high level of competence on routinely used laboratory equipment and/or LIMS systems. Evaluating and setting up new technologies as they are introduced to the lab.
  • Contributing to the general lab environment, including instrument maintenance, writing/updating templates and SOPs, software validation activities, ordering supplies, etc.
  • Coaching and mentoring in a matrix team environment.
  • College/university degree in biological related sciences or equivalent, with 3+ (Masters) or 5+ (Bachelors) years of experience. Experience in regulated biologics bioanalysis preferred.
  • Strong laboratory skills with proficiency in several biological techniques (ELISA, ECL, PCR, etc.) and their associated software.
  • Ability to work with minimal supervision and organize work across multiple projects to meet timelines.
  • Eagerness to take on additional responsibilities when required; flexibility to adapt to changing priorities and strategies.
  • A collaborative spirit and willingness to mentor/coach peers.
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