Inotiv
Bioanalysis Scientist I
Rockville, MD
Sponsorship not specified$80k-$106kDetected 30 days ago
GCPProject ManagementGMPFDA RegulatoryBioinformaticsPCRqPCRCRISPRMolecular BiologyNGSLaTeXResearchProtein AnalysisAnimal StudiesCommunicationCollaborationMicrosoft OfficeGxP
About the role
- This position will require frequent walking, sitting and/or standing for extended periods of time, carrying, heavy lifting (max.
- Due to exposure to hazardous biological material (which may include HIV positive specimens), immunization to Hepatitis B and/or other diseases may be a requirement.
- Professional - Attend continuing education courses or webinars, as appropriate.
Responsibilities
- Collaborate with the director to develop innovative bioanalytical techniques in support of contemporary therapeutic strategies discovered by Inotiv's client base.
- Review all protocols design prior for which he is assigned
- Operate, maintain, and troubleshoot complex analytical instruments and techniques.
- Experience in complex method development and validation in a GxP or CLIA and CRO environment according to FDA and industry guidance documents.
Requirements
- 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 (e.g., proteins, peptides, monoclonal antibodies, oligonucleotides) is required.
- 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 (e.g., qPCR, ddPCR, NGS) and ligand binding assay platforms (ELISA, ELISPOT, MSD, and Luminex), and instruments following lab safety guidelines and using appropriate aseptic techniques.
- Experience interfacing with sponsors/clients on a wide range of bioanalytical method development projects.
Skills
- Demonstrated expertise in bioanalytical best practices and processes.
- Understanding of GLP/GCP/GMP/GCLP regulations; 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.
- Experience with LIMS system and data acquisition software.
- Ability to read, write, speak and understand English
- Able to wear latex or nitrile gloves, and safety glasses as required.
- Ability to read and understand applicable materials
Compensation
- The pay range estimated for this position is $80,100- $105,500.00 annually.
Benefits
- include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!
- This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.
- Adherence to laboratory health and safety procedures
Equal opportunity
- Equal Opportunity Employer.
This listing is sourced directly from Inotiv's careers page and normalized into a canonical job model.