Scientist Immunochemistry- Biotherapeutics
- Expired: over a month ago. Applications are no longer accepted.
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.
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As demand increased, a new Biotherapeutics GLP laboratory is expanding which requires scientists to perform all scientific aspects of this biotherapeutics laboratory, including method development and validation and sample analysis 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.
The scientist 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.
Additional experience in operating flow cytometers and performing basic techniques in molecular biology (e.g., PCR, DNA and RNA analyses) is highly desirable.
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 senior scientist and directors 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 or PI for specific studies as allocated to them by the lab director for GLP 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 (primarily for PK, ADA and
soluble biomarkers) using immunochemistry and cell-based assays, validation and sample management/analysis in support of preclinical drug development.
- Act as study director/study manager/project manager which requires timelyx
feedback to clients on projects.
- Required to assist in various project involving the use of molecular biology,
genomics and flow cytometry methods.
- Collaborate with the senior 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.
- 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
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 and other immunoassay instruments for biotherapeutics and biomarkers.
- Experience working with Watson-LIMS and ELN is desired
- Ph.D. or MSc in Immunology, molecular biology, bioanalytical chemistry, drug metabolism, pharmacokinetics, or related science, with 5+ years of bioanalytical experience preferably in the pharmaceutical industry, or biotech field, or a drug discovery & development, or preclinical, or clinical CRO.
- Biotherapeutics, Biomarker and technical experience is required.
- 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 would be advantageous.
- Experience interfacing with sponsors/clients on a wide range of bioanalytical method development projects would be considered a plus.
- Experience in conducting projects and managing associate scientists and/or lab technicians.
- 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.
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 an equal opportunity and E-Verify employer
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