SCIENTIST -BIOTHERAPEUTICS

SCIENTIST -BIOTHERAPEUTICS

EDUCATION/EXPERIENCE:

• Ph.D., MSC, or BS in Immunology, molecular biology, bioanalytical chemistry, pharmacokinetics, or related science, with 5+ years of bioanalytical experience preferably in the pharmaceutical industry, or CRO.
• Biotherapeutics, genomics and cell-based assay 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.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Be responsible for bioanalytical method development and method validation for PK, ADA and NAB using immunochemistry and cell-based assays, and sample analysis in support of preclinical and clinical drug development.
• 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 new approaches, methodology, and/or the advent of state-of-the-art equipment.
• Required to assist in various project involving the use of genomics and flow cytometry methods.
• Collaborate with the other 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.

SKILLS, SPECIALIZED KNOWLEDGE AND ABILITIES:

• Demonstrated expertise in bioanalytical chemistry best practices and processes.
• Demonstrated expertise in cell tissue culture.
• Expert knowledge of ELISA, MSD and other immunoassay instruments for biotherapeutics and biomarkers.
• Preferably knowledge and experience in genomic analysis as well.
• 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.
• Proficiency with MS Office Suite products.
• Experience working with Watson-LIMS and ELN is desired.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

• Work is normally performed in a typical interior office work or laboratory environment
• Work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and may include use of protective equipment
• The noise level is usually moderate
• This position will frequently be involved with radiant/electrical energy, solvents, grease, oil, irritants, acids, bases, and other hazardous chemicals, electro-mechanical hazards, flammable materials and biohazards. 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.
• Overtime and weekend work as required.
• Work may require the use of PPE (personal protective equipment).
• Might have to lift 20-40 pounds.

Starting salary is $82,100. Exact compensation may vary based on several factors. These factors include, but are not limited to, geographic location, experience, training, education, and local market conditions,

*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.