Senior Scientist/Flow Cytometry and Molecular Biology

Qualifications:              

• Ph.D. or MSc in immunology, cell biology, molecular biology, biochemistry, biotechnology, or related field, with 5+ years of bioanalytical experience and preferred relevant experience in QA/QC or equivalent in the pharmaceutical industry, biotech field or a drug discovery & development or pre-clinical/clinical CRO.
• Knowledge/experience working with biotherapeutics, biomarkers and large molecules (e.g., proteins, peptides, monoclonal antibodies, oligonucleotides) is required – Technical experience working with gene therapy products and small molecule is desired.
• Experience in cell culture and cell-based assay development, and knowledge in immunology and molecular biology. 
• Essential practice of immune assay development using multi-color and multi-parameter flow cytometry, molecular biology (cloning and mutations, gene/proteins expressions and regulations) and high content imaging instrumentation and applications. Proficient in assessing, developing, optimizing, and validating new testing solutions.
• Experience in RNA/DNA purification, RNA transfections, virus infections and proteins expressions in mammalian cells as well as PCR, RT-PCT, qPCR and RT-qPCR techniques. 
• Proficient in data evaluation and validation by using specialized analysis software, such as FlowJo.
• Experience in designing and performing in vitro and pre-clinical models to assess immune responses, immune cell function and immunophenotyping.
• Experience in complex method development and validation in a GxP, CLIA and CRO environment according to FDA and industry guidance documents.
• Experience interfacing with sponsors/clients on a wide range of bioanalytical method development projects.

Corporate Responsibilities:

• Adherence to laboratory health and safety procedures.
• Adherence to Standard Operating Procedures (SOPs).
• Adherence to applicable company policies and guidelines.
• Adherence to federal and/or local regulations, as applicable

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, 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 scientist/senior scientist should have excellent knowledge and experience in flow cytometry techniques, cell-based assays, as well as a working knowledge of PCR, DNA, RNA and protein analyses. 

The scientist of the biotherapeutics laboratory needs 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/director 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 and immunoassay methods development in molecular biology (DNA, RNA and protein) and flow cytometry, validation, and sample management/analysis in support of preclinical and clinical drug development, and biotherapeutics services tasks by maintaining the integrity of data in compliances with standard operating procedures (SOPs) and GxP (GLP, GCP, GMP, GCLP) regulatory guidelines. 
• Identify and develop functional and cell-based assays to support biological characterization of large molecules and novel technologies to improve the immunoassays and facilitate immunological endpoint evaluation for pre-clinical studies.
• 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, and troubleshoot 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.
• Provide directions and guidance to new and junior scientists.
• Support immunological aspects of gene therapy, vaccine developments and biomarker immunoassays.
• Author and review technical documents (protocols, analytical reports, SOPs and raw data summaries).
• Experience in designing and performing in vitro and pre-clinical models to assess immune responses, immune cell function and immunophenotyping.
• Experience in complex method development and validation in a GxP, CLIA and CRO environment according to FDA and industry guidance documents.
• 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 flow-cytometry, molecular biology and various immunoassay platforms (e.g., fluorescence and chemiluminescence) including PCR instruments for biotherapeutics and biomarkers.
• Experience with LIMS system and data acquisition software.

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.