- Analysis, quality control, and data reporting using immunoassay techniques including ELISAs, multiplex analysis and flow cytometry, on clinical samples
- Preparation of blood-derived samples (serum, plasma) from clinical samples
- Maintain sample biobanks and inventories
- Support translational research related to Cartesian's clinical trials
- Assay development for new assays, supporting experimental design, assay evaluation and reporting
- Prepare SOPs and approaches for effective implementation and performance
- Subject matter expert for technical performance and assay performance of biospecimen analysis
- Maintain documentation, experimental data records and protocols following good documentation practices
- Perform general laboratory maintenance and organization
- Masters or PhD degree in biology or life sciences
- Greater than 5 years' experience in immunoassay analysis on biospecimens (post-Masters)
- Greater than 2 years' experience in Translational Research in Industry (since PhD/Masters)
- In depth experience and technical knowledge of immunoassay and other analytical techniques in context of clinical sample analysis
- Experience with aseptic and cell culture techniques
- High level of technical expertise and attention to detail in laboratory work and record keeping
- Experience with standard life science laboratory equipment
- Excellent time management, organizational and documentation skills
- A good understanding of Statistical Analysis and Communication of Translational Research Data
- Experience practicing immunoassays in a Regulated environment with Good Clinical Laboratory Practice or comparable is highly desirable
- Assay development related to immunoassays and flow cytometry is desirable
- Experience and aptitude for development and implementation of translational or biomarker strategies, preparation of scientific publications, presentations, and regulatory documents is a plus
- Local candidates are highly preferred
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Translational Research Scientist - Gaithersburg, United States - Cartesian Therapeutics
Description
Job Description
Job DescriptionSummaryCartesian Therapeutics is seeking a Translational Research Scientist/Senior Scientist with extensive experience in clinical biospecimen analysis to join our team and support translational research related to Cartesians early- to late-stage Clinical Trials. The Scientist will provide subject-matter expertise in a range of translational research strategies, immunoassay techniques, assay development, and fit-for-purpose Regulatory approach. The individual will be responsible for biospecimen analysis using an array of assays to evaluate analytes and biomarkers relevant to late-stage drug development and clinical trials. Responsibilities include coordinating and analyzing samples using immunoassays (ELISA, Luminex, Meso Scale, etc) and cell assays (flow cytometry), maintenance of biobanks and inventories, developing assays, and reporting to cross-functional teams. The ideal candidate will be highly motivated, detail-oriented, and capable of providing high-quality benchwork and technical support in a team setting that values communication and collaboration. The candidate should be comfortable working in a multidisciplinary team, maintaining biobanks, managing and following SOPs, and keeping accurate and timely experimental records.
Principal Duties/Responsibilities:
Qualifications:
Work Environment:
The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.