Responsibilities and Duties
Corporate
• 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 Requirements
Education and experience
- Ph.D. or MSc in immunology, cell biology, molecular biology, biochemistry, biotechnology, or related field, with 3-5 years of bioanalytical experience in pre-clinical/clinical CRO.
- Knowledge/experience working with biotherapeutics, biomarkers and large molecules (e.g., proteins, peptides, monoclonal antibodies, oligonucleotides) is required.
- Experience in method development and validation of large molecules for cell and gene therapy, pharmacokinetic (PK), toxicokinetic and immunogenicity (ADA and Nab).
- Experience with genomics platforms (e.g., qPCR, ddPCR, NGS) and ligand binding assay platforms (ELISA, ELISPOT, MSD, and Luminex), and instruments following lab safety guidelines and using appropriate aseptic techniques.
- Experience in complex method development and validation in a GxP or 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 and abilities
- Demonstrated expertise in bioanalytical 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 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.
Performance requirements
General
- Ability to read, write, speak and understand English
Physical Activity
- Moderate physical activity. This position will require frequent walking, sitting and/or standing for extended periods of time, carrying, heavy lifting (max. 50 lbs), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions (for more than four [4] hours per day)
- Able to wear latex or nitrile gloves, and safety glasses as required.
- Ability to read and understand applicable materials
- Manual dexterity to operate laboratory equipment and calculator/computer
- Able to read and interpret test results and instrument specifications
Working Conditions
- Work is normally performed in a typical interior office or laboratory environment
- Work environment involves exposure to potentially dangerous materials and situations that require following safety precautions and may include use of protective equipment
- This position will frequently involved irritants, acids, bases, and other hazardous chemicals, flammable materials and bio-hazards. Due to exposure to hazardous biological material (which may include HIV positive specimens), immunization to Hepatitis B and/or other diseases may be a requirement.
Specific
- Be responsible for bioanalytical and assay methods development in molecular biology (DNA, RNA and protein), 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 assays to support biological characterization of large molecules and novel technologies to improve the assays and facilitate 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 principal investigator which requires timely feedback to clients on projects.
- Provide directions and guidance to new and junior scientists.
- Author and review technical documents (protocols, analytical reports, SOPs and raw data summaries).
- Train new staff to conduct experiments and troubleshoot experimental issues
- Presents research data/posters in scientific meetings and publish scientific data in reputed journals
- Review all protocols design prior for which he is assigned
- Operate, maintain, and troubleshoot complex analytical instruments and techniques.
- Perform other job duties, as assigned.
Professional
- Attend continuing education courses or webinars, as appropriate.
The pay range estimated for this position is $80,100- $105,500.00 annually. Please note that rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.
*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.
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.
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, and more!
Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.
