„KCAS Bioanalytical & Biomarker Services“ yra pasaulinė bioanalitinių tyrimų sutartinė tyrimų organizacija, remianti farmacijos ir biotechnologijų vaistų kūrimą. Jos darbas, atitinkantis GLP ir GCP reikalavimus, apima imunogeniškumo tyrimus, didelių ir mažų molekulių bioanalizę, srauto citometriją, biomarkerių analizę ir mėginių valdymą. Įmonė turi daugiau kaip keturių dešimtmečių patirtį tokiose terapinėse srityse kaip onkologija, metabolinės, infekcinės ir neurologinės ligos. Ji vykdo veiklą Jungtinėse Valstijose ir Europos Sąjungoje, taip pat yra užmezgusi strategines partnerystes Australijoje. KCAS Bio teigia prisidėjusi prie daugiau kaip 300 FDA patvirtintų vaistų kūrimo ir sukūrusi daugiau kaip 5 000 tyrimų metodų, taip padėdama užsakovams gauti klinikinėms programoms vykdyti reikalingus duomenis.
Senior Report Coordinator, Mass Spectrometry Bioanalysis - Kansas City Hybrid
Coordinate accurate, compliant scientific reporting for LC-MS bioanalysis studies at KCAS Bio. Support drug discovery, preclinical, and clinical research involving drugs, metabolites, biomarkers, and other analytes.
Aprašymas
- Lead the preparation, review, assembly, and finalization of complex reports for mass spectrometry bioanalysis studies.
- Create report sections and import, format, review, and validate scientific data tables and related study information.
- Verify reports for technical accuracy, data consistency, presentation quality, and alignment with protocols, SOPs, and regulatory requirements.
- Investigate and resolve inconsistencies across study data, tables, documentation, and reports with scientists and study teams.
- Manage reporting requirements, revisions, schedules, and final approvals across multiple reports and competing priorities.
- Assist with Quality Assurance reviews and help resolve report-related findings and questions promptly.
- Provide reporting expertise, training, guidance, and mentorship to scientists, study teams, and junior Report Coordinators.
- Contribute to improving reporting templates, SOPs, systems, and operational processes.
- Represent and support the company’s brand, mission, vision, and values.
- Coordinate scientific data and report preparation, review, and completion for bioanalytical studies.
- Convert complex study data and scientific information into accurate, consistent, high-quality study reports.
- Support LC-MS bioanalytical testing for drug discovery, preclinical, and clinical studies involving drugs, metabolites, biomarkers, and other target analytes in biological matrices.
Reikalavimai
- Bachelor’s degree in biological sciences, chemistry, or a related discipline is preferred; equivalent relevant experience may be considered.
- Five or more years of experience in scientific reporting, technical documentation, scientific data presentation, data review, or a related field.
- Proven ability to independently prepare, review, and finalize complex scientific or technical reports.
- Advanced working knowledge of Microsoft Word and Excel, plus experience with scientific data or reporting systems.
- Exceptional attention to detail and the ability to detect and correct discrepancies in scientific data, tables, and reports.
- Strong technical writing, editing, proofreading, organization, and communication abilities.
- Ability to manage multiple reports, priorities, and deadlines independently while working effectively with scientists and cross-functional teams.
- Experience training, guiding, or mentoring less experienced colleagues.
- Experience in a regulated laboratory, pharmaceutical, biotechnology, or contract research organization setting is preferred.
- Mass spectrometry bioanalysis or LC-MS/MS experience is advantageous.
Privalumai
- Company-sponsored activities such as food trucks, family days, and spirit days.
- KCAS University professional development opportunities.
- Wellness, inclusion, and community outreach programs.
- Employee stock ownership program.
- Access to current technology.
- Paid time off for volunteering.
- Reasonable accommodations for people with disabilities and for sincerely held religious beliefs, observances, and practices.