Senior Scientist Immunotherapies and Gene/Cell Therapies Assays
Work schedulePermanent, full time
Start dateAs soon as possible
With unrivaled expertise in immunology, and operating sites in North America (East and West Coast) and Europe, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines, anti-viral drugs, and immunotherapy, gene and cell therapy products.
We are currently looking for a motivated candidate with experience to fill the Senior Scientist position. This position reports to a Principal Scientist/Manager. The Senior Scientist will have relevant experience in bioanalytical and biomarker assays in the field of immunotherapies and gene/cell therapies. The position requires excellent ability to develop and validate bioanalytical and biomarker immunoassay tests, design research methods and testing procedures on a variety of different platforms, troubleshoot assay performance problems, and draft validation reports with minimal supervision and guidance.
- Develops and validates bioanalytical and biomarker immunoassay tests, designs research methods and testing procedures on a variety of different platforms, troubleshoots assay performance problems;
- Is responsible for new assay validation/development progress and completion within projected timeframe;
- Organizes and documents scientific projects and activities;
- Records, reviews, interprets and analyzes study data. Develops study documentation, such as technical protocols, reports, reviews, publications and summaries that meet scientific written standards, and comply with Nexelis’ quality assurance, operations standards and the client-specific requirements;
- Coordinates with internal and external customers to integrate services and data into new and ongoing tests;
- Relays information in a timely manner to supervisory personnel regarding problems that may impact the laboratory’s ability to meet expected service and turn-around-time;
- Performs other duties related to laboratory performance and efficiency as assigned to support the overall objective of the position.
Experience and Qualifications
- Experienced with biomarkers, pharmacokinetic and/or anti-drug antibody (immunogenicity) assays is required;
- Experienced in the fields of immunotherapies and gene/cell therapies, and/or metabolic diseases is desired;
- Understanding Good Laboratory Practice and how it is applied to above services is required;
- The position requires good knowledge of theories and principles of biology/immunology and protein chemistry techniques, such as but not limited to, immunoassays for bioanalytical immunogenicity and pharmacokinetic testing for large molecules;
- Requires well-developed skills using office productivity applications such as spreadsheets, data reduction and statistical applications, and presentation graphics;
- Requires well-developed human relations skills to understand scientific concepts and/or consult with senior colleagues for purposes of problem solving;
- Requires the ability to analyze and solve technical problems under time pressure; Requires the ability to read, interpret and apply complex technical information;
- Must be self-motivated with sense of urgency, detail oriented, well organized and committed to mastering rigorous documentation standards related to GLP and GCP standards.
Bachelor's or Master's degree in biology/immunology or related field with at least 8 years of bench laboratory experience in a clinical or GLP laboratory