Scientist I, Analytical Development

Initial Therapeutics, Inc.; Boca Raton (FL); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

401K plan with employer match

Medical, Vision, Life and Dental Insurance

3 Weeks’ Paid Time Off

Tuition Assistance

Free shuttle to Boca Tri-Rail station

Job summary

ADMA Biologics in Boca Raton, Florida is seeking a Scientist I to provide analytical support for the development and manufacturing of biopharmaceutical products. This role requires technical proficiency, scientific creativity, and collaboration to optimize analytical methods such as ELISA and chromatography.

The ideal candidate has a Bachelor's degree in a relevant discipline, with 4+ years of lab experience and knowledge of regulatory environments. The position offers a dynamic work environment and a comprehensive benefits package.

Qualifications

• Minimum of 4 years of related lab experience with a BS.
• Minimum of 2 years of related lab experience with an MS.
• Experience in Chemical/Biochemical testing.
• Experience in a regulated environment (FDA, EPA).

Responsibilities

• Develop analytical test methods and bioanalytical assays.
• Collaborate cross-functionally with other departments.
• Troubleshoot technical procedures.
• Write technical reports and present findings.

Skills

Analytical test methods

Collaboration

Technical writing

Problem-solving

Data analysis

Education

Bachelor of Science in Biological Sciences, Chemistry, or relevant discipline

Master of Science in Biological Sciences, Chemistry, or relevant discipline (preferred)

PhD in Biological Sciences, Chemistry, or relevant discipline (preferred)

Tools

Excel

cGMP guidelines

Job description

Scientist I, Analytical Development

Boca Raton, Florida

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.

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 group 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‑functionally 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 an 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.

Benefits

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) Easily accessible to Tri‑Rail
• 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, visit https://www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.