Position Summary

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.

Essential Functions (ES) and Responsibilities

• 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

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

• 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 work flow. 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

Preferred Experience

• 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 technical knowledge to obtain and recommend solutions to problems as directed by AD management.
• Maintain an overview of current QC methods and propose areas for improvement.
• Maintain current knowledge in field of expertise through reading articles and attending technical courses.

Compliance Requirements (ES)