Scientist I, Analytical Development

ADMA Biologics, Inc.; Boca Raton (FL); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

401K plan with employer match

Medical, Vision, Life and Dental Insurance

Tuition Assistance

3 Weeks’ Paid Time Off

Free shuttle to Boca Tri-Rail station

Job summary

ADMA Biologics, Inc. is seeking a Scientist I for Analytical Development in Boca Raton, Florida. This role involves developing and validating analytical test methods for protein characterization, collaborating across departments, and maintaining compliance with FDA and cGMP standards.

The ideal candidate should possess a Bachelor’s degree in a relevant field, with additional master's or PhD preferred. Competitive compensation along with a comprehensive benefits package including health insurance, a 401K plan with employer match, and generous paid time off are provided.

Qualifications

• Minimum 4 years of lab experience with a BS required.
• Experience in a regulated environment (FDA, EPA) is necessary.
• Knowledge of cGMP requirements is required.

Responsibilities

• Develop and validate analytical methods for tests and assays.
• Execute experiments to gather data for validations and projects.
• Collaborate with various departments on technical standards.

Skills

Analytical test methods

Protein quantification

Collaborative teamwork

Technical report writing

cGMP compliance

Education

Bachelor of Science in Biological Sciences, Chemistry, or Biochemistry

Master of Science in Biological Sciences, Chemistry, or Biochemistry

PhD in Biological Sciences, Chemistry, or Biochemistry

Tools

Excel

Spectrophotometric methods

Chromatographic techniques

Job description

ADMA Biologics is a biopharmaceutical 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 biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Scientist I, Analytical Development in Boca Raton, Florida!

Position Summary:

The Scientist I, Analytical Development demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. As a key member of the Analytical Development group, provide analytical support for process development and manufacturing. Be responsible for the development, implementation and execution of routine analytical techniques for protein quantification and characterization.

Essential Functions and 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 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.
• Troubleshoot 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 subject matter expertise with analytical technology.

Education & Experience Requirements:

Education:

• Bachelor of Science (BS) in Biological Sciences, Chemistry, Biochemistry or a relevant discipline is required.
• Master of Science (MS) in Biological Sciences, Chemistry, Biochemistry or a relevant discipline is preferred.
• PhD in Biological Sciences, Chemistry, Biochemistry or a relevant discipline is preferred.

Experience:

• A minimum of 4 years of related lab experience with a BS is required.
• A minimum of 2 years of related lab experience with a MS is required.
• Experience in Chemical/Biochemical testing is required.
• Experience in a regulated environment (FDA, EPA, etc.) is required.
• Knowledge of FDA and cGMP requirements are required.

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Free shuttle to the Boca Tri‑Rail station

ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. To learn more about E‑Verify, including your rights and responsibilities, please visit www.dhs.gov/E‑Verify.

ADMA Biologics is an Equal Opportunity Employer.