Scientist I, Analytical Development

Location
Boca Raton, FL
Posted
Oct 14, 2020
Ref
20169
Required Education
Bachelors Degree
Position Type
Full time
ADMA Biologics is a bio pharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the bio pharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We have an exciting opportunity for a Analytical Development Scientist I.

This position is responsible for the development, optimization, validation/qualification, and tech transfer of analytical test methods and bioanalytical assays such as ELISA, spectrophotometric, chromatographic, gel-based, enzymatic activity and chromogenic assays. Design, development, and hands-on execution of analytical studies to support protein characterization and quantitation. Perform experiments as needed to generate data for validations and other special projects. Evaluate and interpret test and experimental data generated from development/qualification and validation work using Excel or other software as required. Collaborate cross-functionality with other departments to select, qualify, and implement reference standards. Execute assigned tasks within the constraints of timelines, under minimal supervision by senior scientific staff. Troubleshoots technical procedures, methodology and instrumentation. Perform instrument calibration or qualification according to written procedures. Serve as primary authors, reviewers, and approvers of regulated documents such as method validation/qualification reports, protocols, transfers, SOPs, change controls, investigational reports, and deviations. Experience in writing technical reports and presenting findings to internal or external clients. Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary. Accountable for following Standard Operating Procedures (SOPs), adhering to cGMP guidelines and all relevant compliance regulations. Use judgment, creativity, and sound technical knowledge to obtain and recommend solutions to problems as directed by AD management. Maintain current knowledge in field of expertise and develop a subject matter expertise with analytical technology.

Qualifications

BS in Biological Sciences, Chemistry, Biochemistry (or relevant discipline) and minimum of 4-5 years of related lab experience. MS in Biological Sciences, Chemistry, Biochemistry (or relevant discipline) and minimum of 2-4 years of related lab experience. PhD in Biological Sciences, Chemistry, Biochemistry (or relevant discipline) and minimum of 0-2 years of related lab experience.

A combination of equivalent education and relevant work experience may also meet these requirements. This position requires experience in Chemical/Biochemical testing, including experience in a regulated environment (FDA, EPA, etc). Knowledge of FDA cGMP requirements is an essential pre-requisite for this position.