Scientist I - III BioPharma Regulatory

Company: KCAS
Location: Olathe
Posted on: June 19, 2022

Job Description:

KCAS Bioanalytical & Biomarker Services is seeking Scientist I, II and III level candidates for positions within its BioPharma Regulatory group in a growing organization in Shawnee, KS.KCAS is a contract research organization (CRO) providing bioanalytical & biomarker services to pharmaceutical clients in support of drug developments, preclinical and clinical studies.As a Scientist in our GLP bioanalytical laboratory at KCAS, you will leverage your knowledge in bioanalysis and scientific principles to be responsible for carrying out and/or supervising all aspects of Ligand-binding studies, from setup through reporting, as well as development. You will utilize your strong base in scientific principles/theories to assess data integrity and troubleshoot when necessary.In the roles of Scientist I, II or III, we will rely on you for the following:

• Plan and carry out all phases of assigned projects including, R&D, ensure adequate supplies, method validation, test procedure preparation, sample analysis, data calculation, interpretation & review, troubleshooting and report preparation.
• Design, troubleshoot, and validate ELISA and Immunogenicity Assays.
• Assess or internalize methods for regulatory and SOP compliance.
• Design moderately complex experiments & evaluate outcome vs. current SOPs, protocols other relevant standards; recommend appropriate course of action as necessary.
• Provide work instructions and technical training to more junior scientific staff in the conduct of assigned projects.
• Interact with clients and/or auditors as necessary.
• Recommend solutions to scientific problems and troubleshooting approaches.
• Perform all aspects of job in a way that supports company brand and supports company mission, vision, and values.(This is a representative summary of responsibilities and is not meant to be exhaustive)WHO YOU ARE:You will thrive at KCAS if you enjoy a fast-paced environment, are open-minded and flexible, can prioritize effectively to solve problems and meet deadlines, embrace high-level performance and constant development, and are self-directed while being drawn to the camaraderie of a team atmosphere.In addition, to qualify specifically for this role, you will have:Education and Experience:Scientist I:
  • Bachelor's degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with 6 years' experience in a scientific laboratory environment; or
  • Master's degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with 4 years' experience in a scientific laboratory environment; or
  • PhD in degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with 2 years' experience in a scientific laboratory environment.Scientist II:
    • Bachelor's degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with 8 years' experience in a scientific laboratory environment; or
    • Master's degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with 6 years' experience in a scientific laboratory environment; or
    • PhD in degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with 4 years' experience in a scientific laboratory environment.Scientist III:
      • Bachelor's degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with 10 years' experience in a scientific laboratory environment; or
      • Master's degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with 8 years' experience in a scientific laboratory environment; or
      • PhD in degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with 6 years' experience in a scientific laboratory environment.Knowledge, Skills and Abilities:
        • Must have ability to design, troubleshoot, and validate ELISA, and Immunogenicity Assays.
        • Experience with design, method development, validation, and sample analysis
        • Thorough understanding of GLP requirements, and Good Documentation Practices (GDP)
        • Experience in organizing and leading teams
        • Manage material, equipment, and instrumentation
        • Analyze and interpret data, prepare summary tables, and review raw data
        • Write SOPs, study plans and reports
        • Communicate with clients, as needed
        • Ability to multi-task and meet deadlines
        • Excellent verbal and written communication and organizational skills.
        • Self-motivated and driven
        • Flexible and adaptable - able to work independently and/or in a team environment.
        • Ability to troubleshoot and problem solve - Critical Thinking
        • Perform all aspects of job in a way that supports company brand and supports company
          mission, vision, and valuesPhysical Requirements:
          • Ability to lift 20 pounds
          • Ability to sit or stand for extended periods of time
          • Ability to convey complex information clearly and concisely
          • Ability to ascend and descend stairsWHAT YOU'LL GET:In addition to a competitive compensation, full suite of medical benefits and time off, you will have the opportunity to be part of employee appreciation events and local community outreach. You'll thrive in a fast-paced environment centered on career progression and development, where we collaborate on impactful contributions and reward for outstanding performance.WHO WE ARE:KCAS is a contract research organization (CRO) headquartered within the metro area of Kansas City, KS. We are uniquely positioned to provide our pharmaceutical clients with both large and small molecule development in support of drug developments, preclinical and clinical studies. Demand for our expertise in bioanalytical & biomarker services is growing and so is our team of dedicated experts - now is a great time to join us to be part of improving the world's health!KCAS is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, sex, sexual orientation, gender identity or any other legally protected category.LIMITATIONS AND DISCLAIMERThe above position description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position.This position description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees may be required to follow additional instructions and to perform other duties as directed by a supervisor. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Continued employment remains on an "at-will" basis.KCAS recruits qualified candidates without regard to citizenship status. We have internal processes in place to enable hiring of the right candidates through appropriate U.S. immigration framework.#LI-JS1IND123

Keywords: KCAS, Olathe , Scientist I - III BioPharma Regulatory, Other , Olathe, Kansas