Biologics Raw Materials Group Leader

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 The ideal candidate would possess:Minimum 5 years related experience in Cell and Molecular Biology preferred.Previous leadership experience preferred.Knowledge of cGMPs and related compliance regulations and guidance(s) required.Knowledge of RT-PCR, flow cytometry and cell based methodologies.Must have experience with the various products and services including stability studies, method development and validation, LIMS, and ELN.This position requires a self-starting, motivated person who possesses excellent interpersonal skills; who is able to assume a leadership role in the laboratory; and, who is able to effectively interact with all departments within the company and with client personnel.Demonstrated skills in laboratory techniques.Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise softwareMinimum 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 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.