ADMA BioCenters · 5 days ago
Senior Scientist, Analytical Development
Boca Raton, FL
Full-time
Onsite
Senior Level
5+ years expADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients. They are seeking a Senior Scientist in Analytical Development to develop, qualify, and validate bioassays, while ensuring compliance with regulatory guidelines and collaborating with cross-functional teams.
BiotechnologyHealth CareProfessional Services
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
Qualification
Required
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
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
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-RailFree shuttle to the Boca Tri-Rail station
Company
ADMA BioCenters
ADMA BioCenters is a fda licensed facility specializing in the collection of human plasma used to make special medication for the treatment.
201-500 employees
Funding
Current Stage
Growth StageRecent News
MarketScreener
2025-11-06
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