Biologics Raw Materials Group Leader

About the role

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.

Responsibilities

• Analyze samples to determine microbiological quality through microbial enumeration methods, absence of specified microorganisms, and endotoxin.
• Coordinate work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).
• Coordinate the scheduling of personnel to maximize productivity.
• Maintain quality performance metrics, conduct routine metrics review and root cause analysis in collaboration with chemists and laboratory management.
• Coordinate and communicate delays and technical issues with management in a timely manner.
• Devise and develop processes and methods for the solution of technical problems.
• Maintain system maintenance and calibration to ensure equipment is operating within specified requirements.
• Train, mentor and supervise analysts (microbiologists).
• Review lab investigations and deviations with analysts/microbiologists.
• Conduct root cause analysis and implement solutions in collaboration with the chemists.
• Perform statistical analysis of data and evaluate the area supervised for microbiological trends, and respond appropriately.

Looking For Someone With Expertise In

• Chromatography
• Empower software
• SECM
• Mass Spectrometry

Qualifications

• 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.

Benefits

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