Scientist PI (Principal Investigator), Biopharma Bioanalytical & Biomarker

KCAS Bioanalytical & Biomarker Services is seeking a Scientist PI (Principal Investigator) for a position within its Bioanalytical and Biomarker 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 PI in our GLP bioanalytical laboratory at KCAS, you will leverage your knowledge in bioanalytical and scientific principles to be responsible for carrying out all aspects of a study, from study 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.

As a Scientist PI you will monitor and make recommendations to procedures with GLP and SOP requirements while developing and instituting processes to improve cost efficiency. You will also interact with clients and participate in FDA and/or client audits.

In the role of Scientist PI, we will rely on you for the following:

As a Scientist:

• Design, plan, and execute bioanalytical assays (ADA, PK, Biomarker and Nab) method development and validation
• Proficient in using common immunoassay platforms (ELISA, MSD, Luminex, etc.)
• Design complex experiments & evaluate outcome vs. regulatory guidelines, white papers and current industry practices.
• Troubleshoot problems and actively participate in the life cycle management of assays.
• Act as lead scientist, 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.
• Act a technical expert for all aspects of process design and problem solving.
• Perform all aspects of job in a way that supports company brand and supports company mission, vision, and values.

As a Principal Investigator:

• Responsible for all client communication related to study conduct.
• Interacts with QAU to resolve identified audit issues and is accountable for continuous quality management in assigned studies.
• Has final authority for sample identification, including discrepancies with clinical sites and/or client.
• Responsible for timeline adherence and communication of status to management as required.
• Ensures compliance of study activities with pertinent portion of study protocol, SOPs & regulatory requirements
• Accountable for final decisions regarding reporting data.
• Ensures laboratory investigations, deviations, validation, and/or reports are initiated and completed as required.
• Has final approval for all data in assigned studies; accountable for quality & integrity of data, methods, and reports.
• Ensures timely archive of all study-related materials.
• Maintains expert knowledge of scientific trends as well as regulatory requirements.

(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 & Experience:

Scientist PI:

• Bachelor’s degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with at least 6 years of experience from CRO or Biotech/Pharmaceutical in large molecule immunoassay development/validation OR
• Master’s degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with at least 4 years of experience from CRO or Biotech/Pharmaceutical in large molecule immunoassay development/validation OR
• PhD in Immunology, Biochemistry, Biotechnology, Biology, or related field and at least 2 years of experience from CRO or Biotech/Pharmaceutical in large molecule immunoassay development/validation

Knowledge, Skills, and Abilities:

• Good knowledge of Good Laboratory Practices (GLP) and Good Clinical Practice (GCP).
• Ability to design, develop, validate, and execute ligand-binding assays including ELISA and ECL-based assays.
• Watson LIMS proficiencies preferred.
• Strong attention to detail.
• Cell based assays experience is a plus
• Good written and verbal communication skills.
• Strong technical writing and basic computer skills.
• Willingness and ability to provide procedural training and coaching.
• Perform all aspects of job in a way that supports company brand and supports company mission, vision, and values.

Physical 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 stairs.

WHAT 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 DISCLAIMER

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.

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