Scientist - Biotherapuetics

COMPANY OVERVIEW:

Inotiv, Inc., is a publicly listed drug discovery and development company with more than 500 employees at 6 sites. Originally founded in 1974 under the name Bioanalytical Systems, Inc. (BASi), the company was reinvented in 2017 when current leadership launched a new strategic plan and vision to become the preferred, “solutions-oriented” CRO. Our headquarters are in West Lafayette, Indiana. 

Inotiv provides contract research services on innovative approaches to drug discovery and development for and with emerging pharmaceutical companies and the world’s leading drug development companies and medical research organizations. By assembling top-class scientists, state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas, Inotiv has a strong foundation to continue our unique leading position as a contemporary drug discovery and development company.

POSITION SUMMARY:

Inotiv’s accelerating growth is fueled in part by a drive to contemporize and innovate across the organization. As Inotiv leverages internal collaboration and diversification to offer best-in-class service to customers, they are committed to continuously accelerate bioanalytical method development and validation processes without any compromise to quality. 

As demand increased, a new Biotherapeutics GLP laboratory is being implemented which requires scientists to perform all scientific aspects of this biotherapeutics laboratory, including 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 a GLP/GCLP laboratory.  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. He/she will also need to work closely with the small molecule bioanalytical laboratory for any LC-MS/MS techniques required for some of these biotherapeutic drugs.

The scientists/senior scientists should have excellent knowledge and experience in ligand binding assay techniques, e.g., ELISA (HELISA, etc.), MSD, Luminex, cell-based assays for PK and Immunogenicity determinations, as well as a working knowledge of PCR, DNA, RNA analysis, LC-MS/MS, as well as flow cytometry. Due to the different techniques involved, some 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 scientists of the Biotherapeutics laboratory need to ensure the smooth transition of programs and assets from discovery, development full GLP and clinical sample analysis (GCLP).

The scientist will work closely with the laboratory manager as consummate bridge-builders and estimable liaison between sponsors and project teams (inter-site and inter-departmental), effectively managing expectations to ensure superior client satisfaction. The scientist would need to act as study directors for specific studies as allocated to them by the lab director for GLP studies or as study manager for GCLP studies.

The scientists will thrive in a collaborative and welcoming environment that values a culture of empowerment, transparency, innovation, agility, professional growth, and credibility. 

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Be responsible for bioanalytical method development (PK, ADA, biomarkers, DNA, RNA, genomics, flow), validation and sample management/analysis in support of preclinical and clinical drug development.
• 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, solve issues, and 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 director/study manager/project manager which requires timely feedback to clients on projects.

PROFESSIONAL QUALIFICATIONS:

Education/Experience:

• Ph.D. or MSc in Immunology, molecular biology, bioanalytical chemistry, drug metabolism, pharmacokinetics, or related science, with 5+ years of bioanalytical experience in the pharmaceutical industry, biotech field or a drug discovery & development or clinical CRO.
• Biotherapeutics, Biomarker and technical experience required - Small molecule experience is desirable.
• Experience in method development and validation of large molecules for PK, ADA and NAb using ELISA, MSD, Luminex, PCR and cell-based assays for e.g., proteins, peptides, monoclonal antibodies, oligonucleotides, essential.  Knowledge on cell and gene therapy products and other biomarker analysis including flow analysis preferable.
• Experience in complex method development and validation in a GxP environment. 
• Experience interfacing with sponsors/clients on a wide range of bioanalytical method development projects.

Skills, Specialized Knowledge and Abilities:

• Demonstrated expertise in bioanalytical chemistry 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 ELISA, MSD, PCR instruments for biotherapeutics and biomarkers.

PERSONAL QUALIFICATIONS:

• Self-driven, creative, and entrepreneurial by being resourceful, optimistic, fiscally responsible, innovative, fearless, determined, open-minded, and focused.
• Balanced and dynamic communication style that radiates honesty, integrity, and credibility through effective use of active listening skills and follow through.
• Superior relationship-building skills with all levels of internal and external stakeholders and clients.
• Compelled to join highly desirable and sought-after employer that that will drive their development toward their aspirations.
• Naturally inquisitive and adept at crafting lines of questions that reveal deep and complete insights into situations and challenges.
• Self-assured and confident, yet humble and open-minded; place the team ahead of personal interests and ambitions.
• Solutions-oriented personality that embraces challenges as opportunities and demonstrates a persistent drive to take initiative and diplomatically resolve issues or challenges
• Strong sense of personal accountability and responsibility; propels throughout the organization.
• Assertive and driven to exceed expectations in a way that inspires others to do the same.
• Exceptional attention to detail and quality; strong organizational capabilities.

At Inotiv our team members come together in support of an organization focused on delivering the experience, knowledge, and responsiveness demanded from an industry striving to bring new cures to market more safely and faster than ever before. Come join our team!  

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, 401K participation with company match, etc. 

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