Principal Scientist - Biotransformation​/Metabolic Identification

Principal Scientist of Biotransformation

The Principal Scientist of Biotransformation will assist with the identification of enzymatic pathways that metabolize drug candidates in preclinical in vitro and in vivo models, including human tissue and cellular models (P450, non-P450/AO/FMO, conjugative/UGT). Working primarily with preclinical species and human tissues/organ subcellular fractions, the individual will utilize contemporary mass spectrometry techniques (LC‑MS/MS) to identify and elucidate drug metabolites (small molecules, peptides, oligonucleotides).

The individual will contribute to the development of in vitro‑to‑in vivo relationships related to drug clearance and half‑life predictions and collaborate with Pharmacology and Toxicology laboratory leadership to establish Novel Approach Methodologies (NAMs) to address mechanistic inquiries and platform screening processes.

• Design and execute laboratory studies to identify enzymatic pathways that metabolize small molecule, peptide, and oligonucleotide therapeutics, establishing the primary enzymes contributing to in vitro metabolism of drug candidates.
• Design and execute laboratory studies to elucidate primary drug clearance mechanisms in vitro, establishing in vitro‑to‑in vivo correlations for predicted human half‑life.
• Collaborate with in vivo pharmacology and toxicology team members to execute ADME studies (non‑radio labeled), elucidating disposition of drug candidates with respect to absorption, distribution, metabolism, and excretion, and supplementing with in vitro protein binding and blood distribution.
• Design and execute in vitro studies for oligonucleotide and peptide molecules to elucidate exonuclease/endonuclease and peptidase metabolism of drug candidates.
• Collaborate with the Toxicology Department to establish cellular models of drug metabolism, induction, and predictive toxicologic mechanisms.

• Experience conducting in vitro and ex vivo biotransformation assays using LC‑MS/MS techniques for quantitation and structural elucidation.
• Knowledge of contemporary bioanalytical techniques, including wet chemistry separations, liquid chromatography, and mass spectrometric analysis, instrument operation, and data processing.
• Knowledge of enzyme kinetics desirable.
• Ability to use software to maintain databases for cataloging records and inventory.
• Independence in the laboratory and data work‑up phases of research.
• Working knowledge of general laboratory procedures.
• Excellent written and oral communication skills.
• Ability to adhere to all safety regulations and procedures.

• PhD in Organic Chemistry, Biochemistry, Analytical Chemistry or related discipline with 2‑5years direct industrial biotransformation experience following postdoctoral training.
• M.Sc. in a related discipline with 5‑7years direct industrial biotransformation experience.
• Working command of in vitro kinetic analysis and contemporary mathematical models to analyze, interpret and model drug clearance, predicted half‑life, and drug‑drug interactions.
• Experience performing mass spectrometry data collection, analysis, and interpretation via LC‑MS/MS.
• Command of pharmacokinetic modeling, analysis, interpretation, and simulation desirable.

Work is normally performed in a typical interior office or laboratory environment. Exposure to potentially hazardous chemicals, solvents, bio‑hazards, and electrical equipment requires adherence to extensive safety precautions and use of protective equipment. The role may involve handling acids, bases, flammable materials, and hazardous biological material (including HIV‑positive specimens). Immunization to hepatitis B and other diseases may be required.

Salary commensurate with experience and responsibilities. Benefits include health and dental coverage, short‑ and long‑term disability, paid time off, paid parental leave, 401(k) participation with company match, and more.

Inotiv is an Equal Opportunity Employer. We 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, assignment, compensation, discipline, termination and access to benefits and training.