Bioanalysis Scientist I

Inotiv•Rockville, MD

19h•Onsite

About The Position

This position is responsible for bioanalytical and assay methods development in molecular biology (DNA, RNA and protein), validation, and sample management/analysis in support of preclinical and clinical drug development, and biotherapeutics services tasks by maintaining the integrity of data in compliance with standard operating procedures (SOPs) and GxP (GLP, GCP, GMP, GCLP) regulatory guidelines. The role involves identifying and developing assays to support biological characterization of large molecules and novel technologies to improve assays and facilitate endpoint evaluation for pre-clinical studies. The scientist will collaborate with the director to develop innovative bioanalytical techniques and ensure compliance with FDA audits. Responsibilities include performing method development, validation, sample analysis, and troubleshooting with internal and external project teams. The role also involves creating and improving standardized tools for method development and validation, identifying opportunities for automation, and exploring new approaches and equipment. The scientist will act as a study principal investigator, providing feedback to clients, and guiding new and junior scientists. Additionally, the role requires authoring and reviewing technical documents, training new staff, presenting research data, and operating/maintaining analytical instruments.

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 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; 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 (e.g., fluorescence and chemiluminescence) including PCR instruments for biotherapeutics and biomarkers.
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
Manual dexterity to operate laboratory equipment and calculator/computer
Able to read and interpret test results and instrument specifications
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.

Nice To Haves

Attend continuing education courses or webinars, as appropriate.

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 in support of preclinical and clinical drug development, and biotherapeutics services tasks by maintaining the integrity of data in compliances with standard operating procedures (SOPs) and GxP (GLP, GCP, GMP, GCLP) regulatory guidelines.
Identify and develop assays to support biological characterization of large molecules and novel technologies to improve the assays and facilitate endpoint evaluation for pre-clinical studies.
Collaborate with the director to develop innovative bioanalytical techniques in support of contemporary therapeutic strategies discovered by Inotiv’s client base.
Ensure compliance is maintained, continuing Inotiv’s phenomenal track record of successful FDA audits.
Regularly perform method development, validation, sample analysis, and troubleshoot failures with internal and external project teams in a collaborative and supportive manner.
Create, maintain, and improve standardized tools for method development and validation activities; identify opportunities for automation to increase speed and efficiency.
Identify new approaches, methodology, and/or the advent of state-of-the-art equipment.
Act as study principal investigator which requires 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
Presents research data/posters in scientific meetings and publish scientific data in reputed journals
Review all protocols design prior for which he is assigned
Operate, maintain, and troubleshoot complex analytical instruments and techniques.
Perform other job duties, as assigned.