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As demand increased, a new Biotherapeutics GLP/GCLP laboratory is being implemented which requires associate scientists to perform bioanalysis in the biotherapeutics laboratory, including running batches for method development and validation for large molecules (peptide/protein therapeutics), monoclonal antibodies, oligonucleotides, cell and gene therapies, ADCs (PK and immunogenicity) and the whole spectrum of biomarkers in regulated environment. All development and validation of these methods need to meet the standards for MDV as prescribed by the FDA, EMA and other Regulatory bodies to fully comply with GLP and GCLP Guidelines. Continuous adaption would be required to scale to ensure the department delivers optimal performance as bioanalytical sciences undertakes a broad spectrum of therapeutics in the drug discovery as well as in the clinical arena in the future. The associate scientists will work closely with the scientists/senior scientists who will be responsible for the overall bioanalytical study and method development and validation in the biotherapeutics laboratory.
The associate scientists should have knowledge and experience in ligand binding assay techniques, e.g., ELISA, MSD, Luminex, cell-based assays for PK and Immunogenicity determinations, or knowledge of PCR, DNA, RNA analysis, as well as flow cytometry. Due to the different techniques involved, some associate scientists would need essential experience in PCR, DNA, RNA, and flow cytometry analysis with a working knowledge of ligand binding assay techniques, e.g., ELISA (HELISA, etc.), MSD, Luminex, cell-based assays for PK and Immunogenicity determinations and LC-MS/MS. Depending on their experience and capabilities they will be placed in the different sections.
The associate scientists of the Biotherapeutics laboratory will perform analysis of samples generated in the GLP/GCLP laboratory for preclinical samples according to the applicable FDA/EMA Guidelines.
The associate scientists will thrive in a collaborative and welcoming environment that values a culture of empowerment, transparency, innovation, agility, professional growth, and credibility providing them the opportunity for promotion to scientists.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Skills, Specialized Knowledge and Abilities:
Inotiv has been named a 2023 Top Workplace! Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K participation with company match, and more!
Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, gender, gender identity, sexual orientation, physical or mental disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.
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