Associate Scientist - Biotherapeutics

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Job description

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/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:

• Be responsible for sample preparation and running batches for bioanalytical method development (PK, ADA, biomarkers, DNA, RNA, genomics, flow), validation and sample analysis in support of preclinical and clinical drug development under the supervision of the scientists.
• Collaborate with the scientists 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.
• Assist with performing method development, validation, sample analysis, solve issues, and failures with internal and external project teams in a collaborative and supportive manner.
• Assist in the creation, maintenance, and improvement of 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.

PROFESSIONAL QUALIFICATIONS:

Education/Experience:

• BSc or MSc in Immunology, molecular biology, bioanalytical chemistry, drug metabolism, pharmacokinetics, or related science, with 1-3 years of bioanalytical experience in the pharmaceutical industry, biotech field or a drug discovery & development or clinical CRO.
• Experience in quantitative analysis of biological samples (e.g. blood, plasma, urine, tissue, etc.) for exogenous (mainly drugs) and endogenous compounds for Biotherapeutics and Biomarker compounds preferred.
• Preferably good knowledge and practical experience with the requirements of ISO and Good Laboratory Practice (GLP) or other laboratory accreditation systems standards.
• Experience in running batches for 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, cell and gene therapy products and other biomarker analysis including flow analysis preferable.
• Experience interfacing with supervising scientists 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.

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.

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