Biologics Raw Materials Group Leader

Responsibilities

Supervise daily laboratory activities and laboratory scheduling; Provide guidance, support, direction, and leadership to technicians and analysts; Responsible for analysis of samples to determine microbiological quality through microbial enumeration methods, absence of specified microorganisms, and endotoxin; Coordinate work projects to prioritize laboratory workload to meet client requirements; Coordinate scheduling of personnel to maximize productivity; Maintain quality performance metrics and conduct routine metrics review and root cause analysis; Coordinate and communicate delays and technical issues with management; Devise and develop processes and methods for solution of technical problems; Responsible for system maintenance and calibration; Train, mentor, and supervise analysts (microbiologists); Review lab investigations and deviations; Conduct root cause analysis and implement solutions; Perform statistical analysis of data and evaluate the area for microbiological trends

Requirements

Bachelor's degree in chemistry, biochemistry, immunology, biology, chemical engineering, pharmaceutical sciences, or related field with five years of relevant experience; Master's degree with three years of directly relevant experience may be substituted; PhD in relevant field may be substituted; Authorization to work in the United States indefinitely without restriction or sponsorship; Minimum five years of relevant experience in biochemistry; Prior leadership or supervisory experience; Strong understanding of cGMP requirements, regulatory compliance, and applicable industry guidance; Demonstrated expertise in analytical techniques including chromatographic and electrophoretic methods, ICP-MS, FTIR, Karl Fischer (KF) methodologies; Experience supporting stability studies, method development and validation, and laboratory systems including LIMS and electronic laboratory notebooks (ELN); Solid understanding of USP and EP compendial requirements; Strong organizational, communication, and interpersonal skills; Proven hands-on laboratory experience and technical proficiency; Proficiency in Microsoft Word, Excel, and Outlook; Expertise in Chromatography; Empower software; SEC; Mass Spectrometry

Nice to have

Experience in cell and molecular biology preferred

Benefits

Comprehensive medical coverage; Life and disability insurance; 401(k) with company match; Paid holidays and vacation; Dental and vision options