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Senior Bioanalytical Chemist

2 months ago

Boca Raton, Florida, United States ADMA BIOMANUFACTURING LLC Full time
Position Overview

Company
ADMA Biomanufacturing LLC

Location
Boca Raton, FL

Employment Type
Full-Time

Educational Background
Bachelor's degree in Chemistry, Biochemistry, Molecular Biology, or a related scientific field is essential.

Role Summary

ADMA Biomanufacturing LLC is dedicated to developing exceptional products for patients with compromised immune systems. Our commitment to this critical demographic drives our innovative approach to production and research. We are currently seeking a Senior Bioanalytical Chemist to join our team in Boca Raton, FL.

The Senior Bioanalytical Chemist will play a vital role in the design, execution, and oversight of quality control assessments. This position involves reviewing documented results to ensure adherence to established specifications and protocols. The ideal candidate will utilize their expertise and creativity to propose effective solutions to challenges encountered in the laboratory.

Key Responsibilities
  • Conduct quality control evaluations for raw materials, in-process samples, and final products, following approved Standard Operating Procedures and cGMP regulations. Ensure thorough documentation and data entry for all testing performed.
  • Maintain a high level of technical proficiency in immunoassays, particularly ELISA methodologies.
  • Provide mentorship and training to junior laboratory personnel as needed.
  • Review and approve cGMP documentation produced by other analysts within the lab.
  • Ensure compliance with Standard Operating Procedures (SOPs) and cGMP guidelines at all times.
  • Conduct testing to generate data for validation processes and special projects as required.
  • Perform instrument calibration and qualification in accordance with established procedures.
  • Draft and review SOPs and Validation Protocols to ensure clarity and compliance.
  • Employ sound judgment and technical knowledge to identify and recommend solutions to issues as directed by Quality Control management.
  • Stay informed of current regulatory standards and practices.
Experience Requirements

A minimum of five years of experience in chemical or biochemical testing, particularly within a regulated environment (such as FDA or EPA), along with a solid understanding of FDA cGMP requirements, is essential for this role.

Benefits
  • 401K plan with employer matching and immediate vesting
  • Comprehensive Medical, Vision, Life, and Dental Insurance
  • Pet Insurance options
  • Company-paid Short-Term and Long-Term Disability Insurance
  • Paid Holidays
  • Three Weeks of Paid Time Off within the first year
  • Tuition Assistance after the first year of employment
  • Convenient access to public transportation
  • Complimentary shuttle service to nearby transit stations
Equal Opportunity Statement

ADMA Biomanufacturing LLC is an Equal Opportunity Employer and uses E-Verify to confirm the employment eligibility of all newly hired employees.