Scientist I, Analytical Development

ADMA Biologics is a biopharmaceutical company focused on creating superior products for immunodeficient patients at risk for infection. We are a dynamic, innovative, and growing company committed to excellence and integrity.

About the role

The Scientist I, Analytical Development demonstrates technical proficiency, scientific creativity, collaboration, and independent thought. As a key member of the Analytical Development group, you will provide analytical support for process development and manufacturing, developing, implementing, and executing routine analytical techniques for protein quantification and characterization.

Responsibilities

• 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 to generate data for validations and other special projects.
• Evaluate and interpret test and experimental data using Excel or other software.
• Collaborate cross-functionally to select, qualify, and implement reference standards.
• Execute assigned tasks within timelines, under minimal supervision by senior scientific staff.
• Troubleshoot technical procedures, methodology, and instrumentation.
• Perform instrument calibration or qualification according to written procedures.
• Serve as primary author, reviewer, and approver of regulated documents such as method validation/qualification reports, protocols, transfers, SOPs, change controls, investigational reports, and deviations.
• Write technical reports and present findings to internal or external clients.
• Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary.
• Adhere to Standard Operating Procedures (SOPs), cGMP guidelines, and all relevant compliance regulations.
• Use judgment, creativity, and sound technical knowledge to obtain and recommend solutions to problems.
• Maintain current knowledge in your field of expertise and develop subject matter expertise with analytical technology.

Requirements

• Bachelor of Science (BS) in Biological Sciences, Chemistry, Biochemistry, or a relevant discipline is required.
• Master of Science (MS) or PhD in Biological Sciences, Chemistry, Biochemistry, or a relevant discipline is preferred.
• A minimum of 4 years of related lab experience with a BS, or 2 years with an MS.
• Experience in Chemical/Biochemical testing.
• Experience in a regulated environment (FDA, EPA, etc.).
• Knowledge of FDA and cGMP requirements.

Compliance Requirements

• Strict adherence to FDA regulations and company policies governing activities.
• Completion of required compliance training.
• Accurate documentation of interactions and adherence to data privacy regulations.
• Proactive participation in compliance reviews and prompt reporting of potential issues.
• Ongoing education to stay updated on relevant FDA regulations.

Benefits

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life, and Dental Insurance
• Pet Insurance
• Company-paid Short-Term Disability (STD) and Long-Term Disability (LTD)
• Company-paid holidays
• 3 weeks’ paid time off (within the first year)
• Tuition assistance (after the first year)
• Easily accessible to Tri-Rail with a free shuttle to the Boca Tri-Rail station