Biologics Raw Materials Group Leader
About The Position
Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services. We are looking for a Biologics Raw Materials Group Leader to supervise daily laboratory activities and laboratory scheduling to ensure optimum group performance. This role provides guidance, support, direction, and leadership to technicians and analysts through positive interactions with all personnel during daily operations. The position is responsible for the analysis of samples to determine microbiological quality through microbial enumeration methods, absence of specified microorganisms, and endotoxin testing. The Group Leader will coordinate work projects to appropriately prioritize laboratory workload to meet client requirements related to quality, on-time performance, and turnaround time (TAT). This includes coordinating the scheduling of personnel to maximize productivity, maintaining quality performance metrics, conducting routine metrics review, and root cause analysis in collaboration with chemists and laboratory management. The role also involves coordinating and communicating delays and technical issues with management in a timely manner, devising and developing processes and methods for technical problem-solving, and ensuring system maintenance and calibration. Additionally, the Group Leader will train, mentor, and supervise analysts (microbiologists), review lab investigations and deviations, conduct root cause analysis, and perform statistical analysis of data to evaluate microbiological trends and respond appropriately.
Requirements
- Expertise in Chromatography
- Expertise in Empower software
- Expertise in SEC Mass Spectrometry
- 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.
- 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
Nice To Haves
- Experience in cell and molecular biology preferred.
Responsibilities
- 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.
Benefits
- Comprehensive medical coverage
- Life and disability insurance
- 401(k) with company match
- Paid holidays and vacation
- Dental and vision options
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What This Job Offers
Job Type
Full-time
Career Level
Manager
