BioSpace
Overview
Scientist I, Analytical Development in Boca Raton, Florida. Job Title: Scientist I, Analytical Development. ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. The role provides analytical support for the process development group and manufacturing, with development, implementation and execution of routine analytical techniques for protein quantification and characterization. Responsibilities
Development, optimization, validation/qualification, and tech transfer of analytical test methods and bioanalytical assays such as ELISA, spectrophotometric, chromatographic, gel-based, enzymatic activity and chromogenic assays. Design, development, and hands-on execution of analytical studies to support protein characterization and quantitation. Perform experiments to generate data for validations and other special projects. Evaluate and interpret test data from development/qualification and validation work using Excel or other required software. Collaborate cross-functionally with other departments to select, qualify, and implement reference standards. Execute assigned tasks within timelines, under minimal supervision by senior scientific staff. Troubleshoot technical procedures, methodology and instrumentation. Perform instrument calibration or qualification according to written procedures. Serve as primary authors, reviewers, and approvers of regulated documents such as method validation/qualification reports, protocols, transfers, SOPs, change controls, investigational reports, and deviations. Experience in writing technical reports and presenting findings to internal or external clients. Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary. Follow Standard Operating Procedures (SOPs), adhere to cGMP guidelines and all relevant compliance regulations. Use judgment, creativity, and technical knowledge to obtain and recommend solutions as directed by AD management. Maintain current knowledge in the field and develop subject matter expertise with analytical technology. Qualifications
Education: Bachelor of Science (BS) in Biological Sciences, Chemistry, Biochemistry or relevant discipline required. Master of Science (MS) and PhD in these fields preferred. Experience: A minimum of 4 years of related lab experience with a BS; a minimum of 2 years with an MS; experience in Chemical/Biochemical testing; experience in a regulated environment (FDA, EPA, etc.); knowledge of FDA and cGMP requirements. Job Requirements / Competencies
Ability to follow cGMPs and procedures with great attention to detail Ability to work in a high-pressure, deadline-driven environment Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines Time management skills and ability to balance multiple assignments Excellent oral and written communication skills with attention to detail and accuracy Ability to collaborate effectively with cross-functional teams 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; company paid shuttle to the Boca Tri-Rail station Compliance & Equal Opportunity
ADMA Biologics uses E-Verify to confirm employment eligibility. ADMA Biologics is an Equal Opportunity Employer.
#J-18808-Ljbffr
Scientist I, Analytical Development in Boca Raton, Florida. Job Title: Scientist I, Analytical Development. ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. The role provides analytical support for the process development group and manufacturing, with development, implementation and execution of routine analytical techniques for protein quantification and characterization. Responsibilities
Development, optimization, validation/qualification, and tech transfer of analytical test methods and bioanalytical assays such as ELISA, spectrophotometric, chromatographic, gel-based, enzymatic activity and chromogenic assays. Design, development, and hands-on execution of analytical studies to support protein characterization and quantitation. Perform experiments to generate data for validations and other special projects. Evaluate and interpret test data from development/qualification and validation work using Excel or other required software. Collaborate cross-functionally with other departments to select, qualify, and implement reference standards. Execute assigned tasks within timelines, under minimal supervision by senior scientific staff. Troubleshoot technical procedures, methodology and instrumentation. Perform instrument calibration or qualification according to written procedures. Serve as primary authors, reviewers, and approvers of regulated documents such as method validation/qualification reports, protocols, transfers, SOPs, change controls, investigational reports, and deviations. Experience in writing technical reports and presenting findings to internal or external clients. Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary. Follow Standard Operating Procedures (SOPs), adhere to cGMP guidelines and all relevant compliance regulations. Use judgment, creativity, and technical knowledge to obtain and recommend solutions as directed by AD management. Maintain current knowledge in the field and develop subject matter expertise with analytical technology. Qualifications
Education: Bachelor of Science (BS) in Biological Sciences, Chemistry, Biochemistry or relevant discipline required. Master of Science (MS) and PhD in these fields preferred. Experience: A minimum of 4 years of related lab experience with a BS; a minimum of 2 years with an MS; experience in Chemical/Biochemical testing; experience in a regulated environment (FDA, EPA, etc.); knowledge of FDA and cGMP requirements. Job Requirements / Competencies
Ability to follow cGMPs and procedures with great attention to detail Ability to work in a high-pressure, deadline-driven environment Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines Time management skills and ability to balance multiple assignments Excellent oral and written communication skills with attention to detail and accuracy Ability to collaborate effectively with cross-functional teams 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; company paid shuttle to the Boca Tri-Rail station Compliance & Equal Opportunity
ADMA Biologics uses E-Verify to confirm employment eligibility. ADMA Biologics is an Equal Opportunity Employer.
#J-18808-Ljbffr