Biologics Raw Materials Group Leader
Eurofins USA BioPharma Services
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. The Group also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
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
Qualifications
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
Additional Information
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.
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
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