GCP Bioanalysis Senior Scientist
vor 4 Wochen
We are seeking a highly skilled GCP Bioanalysis Senior Scientist to join our Translational Medicine Drug Disposition Bioanalytical group. As a key member of our team, you will be responsible for developing, validating, and analyzing clinical samples for our novel modality biologics portfolio.
Key Responsibilities:- Design, develop, and validate assays, and perform sample analysis using biological techniques for PK, PD, and immunogenicity following SOPs and guidelines.
- Be responsible for all assigned study/lab/project activities, and provide 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 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.
- Collaborative spirit and willingness to mentor/coach peers.
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