Bioanalysis Scientist I

Job Responsibilities

• Adherence to laboratory health and safety procedures
• Adherence to Standard Operating Procedures (SOPs)
• Adherence to applicable company policies and guidelines
• Adherence to federal and/or local regulations, as applicable
• Responsible for bioanalytical and assay methods development in molecular biology (DNA, RNA and protein), validation, and sample management/analysis for preclinical and clinical drug development, and biotherapeutics services tasks
• Identify and develop assays to support biological characterization of large molecules and novel technologies
• Collaborate with the director to develop innovative bioanalytical techniques in support of contemporary therapeutic strategies
• Ensure compliance is maintained with GLP, GCP, GMP and GCLP regulatory guidelines and continuing successful FDA audits
• Regularly perform method development, validation, sample analysis, and troubleshoot failures with internal and external project teams
• Create, maintain, and improve standardized tools for method development and validation activities; identify opportunities for automation to increase speed and efficiency
• Act as study principal investigator requiring timely feedback to clients on projects
• Provide directions and guidance to new and junior scientists
• Author and review technical documents (protocols, analytical reports, SOPs and raw data summaries)
• Train new staff to conduct experiments and troubleshoot experimental issues
• Present research data/posters in scientific meetings and publish scientific data in reputable journals
• Review all protocol designs prior to assignment
• Operate, maintain, and troubleshoot complex analytical instruments and techniques
• Perform other job duties as assigned

• Ph.D. or MSc in immunology, cell biology, molecular biology, biochemistry, biotechnology, or related field, with 3-5 years of bioanalytical experience in pre‑clinical/clinical CRO
• Knowledge/experience working with biotherapeutics, biomarkers and large molecules (proteins, peptides, monoclonal antibodies, oligonucleotides)
• Experience in method development and validation of large molecules for cell and gene therapy, pharmacokinetic (PK), toxicokinetic and immunogenicity (ADA and Nab)
• Experience with genomics platforms (qPCR, ddPCR, NGS) and ligand binding assay platforms (ELISA, ELISPOT, MSD, Luminex) and instruments under lab safety guidelines using aseptic techniques
• Experience in complex method development and validation in a GxP or CLIA and CRO environment according to FDA and industry guidance documents
• Experience interfacing with sponsors/clients on a wide range of bioanalytical method development projects
• Demonstrated expertise in bioanalytical best practices and processes
• Understanding of GLP/GCP/GMP/GCLP regulations and ability to apply practices daily
• Excellent written and verbal communication skills (English required); open, interactive style that facilitates high levels of trust
• Exceptional project management and organizational skills
• Exceptional partnering and collaboration skills with stakeholders at all levels
• Superior interpersonal skills that demonstrate high levels of emotional intelligence and critical thinking
• Self‑starter, capable of working independently to generate desired results
• Proficiency with MS Office Suite products
• Expert knowledge of molecular biology and various immunoassay platforms (fluorescence and chemiluminescence) including PCR instruments for biotherapeutics and biomarkers
• Experience with LIMS system and data acquisition software

• General ability to read, write, speak and understand English
• Moderate physical activity: frequent walking, sitting and/or standing for extended periods of time, carrying, heavy lifting (max. 50 lbs), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions (for more than four [4] hours per day)
• Ability to wear latex or nitrile gloves, and safety glasses as required
• Manual dexterity to operate laboratory equipment and calculator/computer
• Ability to read and interpret test results and instrument specifications

Work is normally performed in a typical…