Scientist I Analytical Development

Description

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.  If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics.  We currently have an exciting opportunity available for a Scientist I centrally located in Boca Raton, FL!
 

Demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought.  As a key member of the Analytical Development group provide analytical support for process development group and manufacturing. Be responsible for the 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 as needed to generate data for validations and other special projects.
• Evaluate and interpret test and experimental data generated from development/qualification and validation work using Excel or other software as required.
• Collaborate cross-functionality with other departments to select, qualify, and implement reference standards.
• Execute assigned tasks within the constraints of timelines, under minimal supervision by senior scientific staff.
• Troubleshoots 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.
• Accountable for following Standard Operating Procedures (SOPs), adhering to cGMP guidelines and all relevant compliance regulations.
• Use judgment, creativity, and sound technical knowledge to obtain and recommend solutions to problems as directed by AD management.
• Maintain current knowledge in field of expertise and develop a subject matter expertise with analytical technology.

Qualifications

Education/Experience Requirements:            

BS in Biological Sciences, Chemistry, Biochemistry (or relevant discipline) and minimum of 4-5 years of related lab experience. MS in Biological Sciences, Chemistry, Biochemistry (or relevant discipline) and minimum of 2-4 years of related lab experience. PhD in Biological Sciences, Chemistry, Biochemistry (or relevant discipline) and minimum of 0-2 years of related lab experience.  A combination of equivalent education and relevant work experience may also meet these requirements. This position requires experience in Chemical/Biochemical testing, including experience in a regulated environment (FDA, EPA, etc). Knowledge of FDA cGMP requirements is an essential pre-requisite for this position.

Other Essential Knowledge:                             

Extensive experience with chemical/biochemical testing is necessary.  The individual should have direct experience with HPLC and GC and one or more of the following: spectrophotometric assays, immunochemical methods, titration assays, SDS PAGE, IEF, various ELISAs and/or IR spectroscopy. The individual should possess good communication skills, be highly motivated, detail-oriented, and able to work well with others. The individual should be flexible and able to handle multiple priorities. Able to use personal computer, perform dilutions and math calculations, understand and follow instructions, record information, find solutions to practical problems or request assistance. Knowledgeable of the different laboratory areas. 

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 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 www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employee