Senior Scientist, Analytical Development

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. 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 & 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 a 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. Competencies 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. Experience Requirements Education: Masters or PhD in a scientific discipline such as Chemistry, Analytical Chemistry, Biochemistry, Biological Sciences, Engineering or equivalent is required. 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: 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: 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. Benefits 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, please visit ADMA Biologics is an Equal Opportunity Employer. #J-18808-Ljbffr ADMA BioCenters