Senior Scientist, Analytical Development

Senior Scientist, Analytical Development

Join ADMA Biologics, Inc., a biopharmaceutical company committed to creating superior products for immunodeficient patients.

Senior Scientist, Analytical Development (Mid‑Senior level, Full‑time, Boca Raton, FL).

Demonstrated technical proficiency, scientific creativity, collaboration and independent thought with a focus on complex analytical problems.

• Develop, qualify, and validate bioassays with minimal supervision, write SOPs and transfer methods to the QC department.
• Design experiments and write protocols for assay development and validation.
• Perform assays or supervise analysts for assay development and validation work.
• Frequently write technical reports and present findings internally or to 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 using mammalian cell culture techniques.
• Use analytical techniques, software, and instrumentation such as HPLC, GC, spectrophotometric assays, immunochemical methods, titration assays, SDS‑PAGE, IEF, ELISAs, enzymatic assays, and IR spectroscopy.
• Possess familiarity with regulatory guidelines pertaining to assay development, qualification, and validation.
• Be familiar with BSL‑2 laboratories and work in a BSL‑2 environment.

• Education:
  
  Masters or PhD in Chemistry, Analytical Chemistry, Biochemistry, Biological Sciences, Engineering or equivalent.
• Minimum 5 years industrial experience with extensive experience in chemical/biochemical and biological testing.
• Expert knowledge of scientific principles and concepts; extensive experience with mammalian cell culture techniques, bioassay development, neutralization assays, method transfer, and bioassay validation.
• Knowledge of working in a BSL‑2 environment and familiarity with required guidelines and procedures.
• Physical requirements:
  
  work under BSL‑2 conditions, exposure to infectious materials, toxic chemicals, fumes, electrical hazards, temperature extremes, and routine lab hazards.
• Must walk, sit, stand, carry, lift, and pull; regular close sight required.

• Work collaboratively in cross‑functional teams and 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 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.

• 401(k) 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)
• Travel to Tri‑Rail station via free shuttle

• Must operate according to company SOPs and other guidelines at all times.

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ADMA Biologics is an Equal Opportunity Employer.