GCP Bioanalysis Senior Scientist

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.

Essential requirements:

• 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