Scientist I, Analytical Development (Biotechnology)

Location: Onsite in Boca Raton, Florida, United States

Company

ADMA Biologics is a biopharmaceutical company developing products for immunodeficient patients at risk of infection.

What you will do

• Develop, optimize, validate, qualify, and transfer analytical test methods and bioanalytical assays.
• Design and execute studies supporting protein characterization and quantification.
• Generate, evaluate, and interpret data from analytical development, qualification, and validation experiments.
• Collaborate with process development, manufacturing, and other departments to qualify and implement reference standards.
• Troubleshoot analytical procedures and instrumentation, and perform instrument calibration or qualification.
• Author, review, and approve regulated documents, including validation reports, protocols, SOPs, change controls, investigations, and deviations.

Requirements

• Bachelor of Science in biological sciences, chemistry, biochemistry, or a relevant discipline is required.
• At least 4 years of related laboratory experience with a BS, or at least 2 years with an MS, is required.
• Experience in chemical or biochemical testing is required.
• Experience working in a regulated environment, such as FDA- or EPA-regulated operations, is required.
• Knowledge of FDA and cGMP requirements is required.
• Ability to prepare technical reports, present findings, follow SOPs, and work with minimal supervision.

Nice to have

• Master of Science or PhD in biological sciences, chemistry, biochemistry, or a relevant discipline.

Culture & Benefits

• 401(k) plan with employer match and immediate vesting.
• Medical, vision, life, dental, and pet insurance.
• Company-paid short-term and long-term disability coverage.
• Company-paid holidays and three weeks of paid time off during the first year.
• Tuition assistance after the first year.
• Access to Tri-Rail and a free shuttle to the Boca Tri-Rail station.