Chemist II, Bioanalytics

Job 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 Chemist II, Bioanalytics in Boca Raton, FL!

Job Title: Chemist II, Bioanalytics

Job Description:

Position Summary

The Chemist II, Bioanalytics will perform quality control testing of raw materials, in-process, and final products with minimal supervision, with a concentration in immunoassays. Uses knowledge of corporate policies to resolve routine problems and ensure compliance with procedures.

Essential Functions (ES) And Responsibilities

• Perform quality control testing for raw materials, in-process, and final product samples, according to approved Standard Operating Procedures (SOPs) and cGMP guidelines
• Complete testing documentation and data entry as required for procedures and tests performed
• Apply knowledge of analyzing issues and uses judgment to make decisions
• Knowledge of immunoassays, specifically plate-based assays and ELISAs
• Utilize cGMP practices in documentation and execution of job functions
• Perform instrument calibration or qualification according to written procedures
• Write and revise SOPs and/or participate in validation protocol execution, as needed
• Perform testing, as needed, to generate data for qualification/validation and special projects
• Fulfill requests from management for assistance in other matters, as needed
• Accountable for following SOPs and adhering to cGMP guidelines
• Review documentation on trained tasks as assigned by QC management
• Use technical and scientific knowledge to recommend solutions to problems as directed by QC management
• Mentor junior analysts and provide training as requested on QC assays.
  
  
  

Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP’s and procedures with great attention to detailAble to work in high-pressure, deadline-driven environmentDemonstrated ability to achieve goals, overcome obstacles, and meet deadlinesPossess time management skills and be able to balance multiple job assignments at oncePossesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendationsExperience Requirements

Education Requirements: Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology, or related science discipline.

Experience Requirements: At least three years of experience performing chemical/biochemical testing or developing immunoassays. Work in a regulated environment (FDA, EPA, etc.) is highly preferred.

Preferred Experience Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

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
• Company paid 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 Employer.