Senior Scientist, Analytical Development

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 Senior Scientist, Analytical Development
.

Demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. Works on complex problems in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

• Develop, qualify, validate Bioassays with minimum supervision, write SOPs and transfer methods to QC department as needed.
• Be familiar with regulatory guidelines pertaining to assay development/qualification/validation.
• Be familiar with BSL-2 laboratories and working in BSL-2 environment.
• Design experiments and write protocols for assay development and validation.
• Perform assays or supervise other analysts for assay development and validation work.
• Frequently write technical reports and present findings to internal or external clients.
• Analyze experimental data with appropriate statistical tools and report scientific results.
• Interpret data and adhere to strict guidelines on documentation when recording data.
• Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary.
• Analyze samples from various sources to provide information on compounds or quantities of compounds present. Use of mammalian cell culture techniques.
• Use analytical technique, software, and instrumentation, such as HPLC, GC, spectrophotometric assays, immunochemical methods, titration assays, SDS PAGE, IEF, ELISAs, enzymatic assays and/or IR spectroscopy.

Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines. Possesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross‑functional teams and communicate findings and recommendations. Possesses strong organizational, critical thinking, reasoning, and problem‑solving abilities.

• Education Requirements: Masters or PhD in a scientific discipline such as Chemistry, Analytical Chemistry, Biochemistry, Biological Sciences, Engineering or equivalent is required.
• Experience Requirements: Minimum 5 years of industrial experience. Expert knowledge of scientific principles and concepts. Extensive experience with chemical/biochemical and biological testing is necessary. The individual should have experience with one or more of the following: mammalian cell culture techniques, Bioassay development, neutralization assays, method transfer, Bioassay development and validation. Knowledge of working in a BSL-2 environment and be familiar with required guidelines and procedures.
• Physical Requirements (ES):
• Working under BSL-2 conditions, exposure to infectious materials (human source products), toxic chemicals, chemical fumes and odors, electrical hazards, temperature extremes when going to and from coolers and freezers.
• Stressors:
  Maintain workflow. Assuring high quality product, within ADMA’s SOPs and other guidelines at all times.
• Physical Demands:
  Must walk, sit, stand, carry, lift and pull; some close sight required. Exposure to human source products, odors, and sudden temperature changes under normal laboratory conditions.
• Physical Location of Role: Boca Raton, FL

• Work collaboratively in cross‑functional teams. Interact with contract labs in method development/qualification/validation.
• Be aware of and keep up to date with health and safety issues in all aspects of the work undertaken.
• Use judgment, creativity and sound…