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Director - In Vivo Operations

Employer
Inotiv
Location
West Lafayette, IN
Start date
Aug 5, 2022

View more

Discipline
Manufacturing & Production, Operations
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest

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Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity.  Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world.  There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen.

Join us in embracing research and science to impact the health and well-being of people all over the world.

Job Summary

Inotiv is seeking a Drug Metabolism & Disposition-focused Pharmacology leader that will build and direct a team and operation responsible for the design and execution of in vivo ADME studies in support of traditional small molecule therapies and novel biotherapeutics.

Essential Duties and Responsibilities

·Serve as the in vivo DMPK subject matter expert (SME) on Discovery- and Development-staged project teams.

·Design and direct the execution of discovery-, preclinical-, and nonclinical-staged studies to understand the pharmacokinetics (PK) and Absorption, Metabolism, Distribution, and Excretion (ADME) of traditional and novel biotherapeutic products including, small molecules, monoclonal antibodies, oligonucleotides/peptides, and select cell & gene therapy derived agents.

·Utilize a diverse set of in vivo tools, dose-sampling approaches, and surgical models to aid in the elucidation of PK/PD attributes of an experimental or clinically approved therapeutic in order to translate exposure and/or effect relationships important in discovery, as well as in preclinical to clinical stages of development.

·Design and execute radiolabeled studies towards the determination of a therapeutic’s absolute bioavailability, mass balance, ADME attributes and metabolite.

·Author high quality non-regulated and regulated documents including, but not limited to reports in support of nonclinical summaries while partnering with and supporting Pharmacology, Toxicology, DMPK and Project Management.

·Knowledgeable of regulatory guidance relating to DMPK and select guidances related to the translation of PK and drug metabolism from nonclinical species to the clinic.

·Participate in the design and management of cross-site (Inotiv sites) client projects and programs during various stages of discovery and preclinical drug development.

 

Skills and Abilities

·Excellent organizational, written, and oral communication skills

·An attitude for quality; detail-oriented

·Demonstrate an understanding of and adhere to facility SOPs and Good Laboratory Practice Regulations (21CFR, Part 58) as they relate to study specific services provided, this job description, and general facility operations

·A working knowledge and awareness of general laboratory procedures

·Ability to use personal computer and various software programs

·Ability to work independently

·Interact with clients, other employees, and the community in a professional manner

·Maintain confidential information

·Support and participate in other company initiatives as directed

·Ability to read, write, speak, and understand English

·Demonstrate Inotiv Core Values and adhere to Code of Conduct

Education and Experience

·PhD and 5 years of industry experience

·MS and 10 years of industry experience

·BS and 15 years of industry experience

·Equivalent combination of related education and required work experience will be considered with management approval.

 

Physical Activity and Working Conditions

·Work is normally performed in a typical interior office or laboratory environment

·Prolonged periods of sitting at a desk and working on a computer

·The noise level is usually moderate

·Requires moderate physical activity with frequent talking, standing, walking and repetitive movement of hands and fingers, reaching and lifting 10 -20 pounds.

·Use of PPE (Personal Protection Equipment) when required (i.e., able to wear latex or nitrile gloves, dust mask or respirator, and safety glasses as required)

 

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, etc. 

Inotiv is a proud equal opportunity employer and an E-Verify employer.

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