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Biologics Raw Materials Group Leader

Eurofins · Columbia, MO, United States

Diagnostics / LaboratoryExternal listingfull-timeabout 1 hour ago

About The Role

Responsibilities include

  • Supervise daily laboratory activities and laboratory scheduling to ensure optimum group performance.
  • Provides guidance, support, direction and leadership to technicians and analysts through positive interactions with all personnel during daily operations.
  • Responsible for the analysis of samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, and endotoxin.
  • Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).
  • Coordinates the scheduling of personnel to maximize productivity.
  • Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with chemists and laboratory management.
  • Coordinates and communicates delays and technical issues with management in a timely manner.
  • Devises and develops processes and methods for the solution of technical problems.
  • Responsible for system maintenance and calibration to ensure equipment is operating within specified requirements.
  • Trains, mentors and supervises analysts (microbiologists).
  • Reviews lab investigations and deviations with analysts/microbiologists.
  • Conducts root cause analysis and implements solutions in collaboration with the chemists.
  • Performs statistical analysis of data and evaluates the area supervised for microbiological trends, and responds appropriately.

Looking for someone with expertise in

  • Chromatography
  • Empower software
  • SEC
  • Mass Spectrometry 

The ideal candidate would possess

  • A minimum of five years of relevant experience in biochemistry, with experience in cell and molecular biology preferred.
  • Prior leadership or supervisory experience
  • A strong understanding of cGMP requirements, regulatory compliance, and applicable industry guidance.
  • Demonstrated expertise in a broad range of analytical techniques, including chromatographic and electrophoretic methods, ICP-MS, FTIR, Karl Fischer (KF) methodologies.
  • Experience supporting and overseeing services such as stability studies, method development and validation, and the use of laboratory systems including LIMS and electronic laboratory notebooks (ELN).
  • A solid understanding of USP and EP compendial requirements and their application in a regulated laboratory environment.
  • Strong organizational, communication, and interpersonal skills, with the ability to take initiative, assume a leadership role within the laboratory, and effectively collaborate with internal departments and client personnel.
  • Proven hands-on laboratory experience and demonstrated technical proficiency in laboratory techniques and troubleshooting.
  • Proficiency in Microsoft Word, Excel, and Outlook, as well as the ability to effectively utilize enterprise software systems.

Minimum Qualifications

  • Bachelor’s degree in relevant field such as chemistry, biochemistry, immunology, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework in the above areas and a minimum of five years of experience in a directly relevant setting.
  • Master’s degree in a relevant field and three years of directly relevant experience may be substituted for the bachelor’s degree and experience.
  • PhD in a relevant field may be substituted for bachelor’s degree and experience.
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Position is Full-time, Monday-Friday, 8:00 a.m.-4:30 p.m., with additional hours, as needed.  Candidates currently living within a commutable distance of Columbia, MO  are encouraged to apply. 

 We offer excellent full-time benefits including

  • Comprehensive medical coverage,
  • Life and disability insurance,
  • 401(k) with company match,
  • Paid holidays and vacation, 
  • Dental and vision options.
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  • Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

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