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ADMA Biologics, Inc. · 17 hours ago

Senior Scientist, Analytical Development

Boca Raton, FL

Full-time

Onsite

Senior Level

5+ years exp

ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. They are seeking a Senior Scientist in Analytical Development to work on complex problems, develop and validate bioassays, and collaborate with cross-functional teams.

BiotechnologyHealth CareManufacturingMedical

No H1B

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

Bioassay developmentHPLCMammalian cell cultureBSL-2 environmentStatistical analysisTechnical writingCollaborationProblem-solvingCommunication skills

Required

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

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

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