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Biologics Raw Materials Group Leader
Eurofins · Columbia, MO, United States
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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