Eurofins Lancaster Laboratories

Biologics Raw Materials Group Leader

Eurofins Lancaster Laboratories$95K — $115K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Minimum five years of relevant experience in biochemistry; cell and molecular biology experience preferred.
  • Prior leadership or supervisory experience.
  • Strong understanding of cGMP requirements and regulatory compliance.
  • Expertise in analytical techniques, including chromatography and electrophoresis.
  • Experience with stability studies, method development, and lab systems such as LIMS.
  • Solid knowledge of USP and EP compendial requirements.
  • Strong organizational and interpersonal skills.

Responsibilities

  • Supervise daily lab activities and scheduling for optimal group performance.
  • Provide leadership and support to technicians and analysts through positive interactions.
  • Analyze samples for microbiological quality using various enumeration methods.
  • Coordinate lab projects and personnel scheduling to meet client requirements.
  • Maintain quality performance metrics and conduct root cause analyses with laboratory management.
  • Communicate delays and technical issues to management promptly.
  • Develop processes for the resolution of technical problems.

Benefits

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

About Eurofins Lancaster Laboratories

Eurofins Lancaster Laboratories is a leading contract research organization (CRO) providing analytical, research and testing services to clients in the pharmaceutical, biopharmaceutical, biotechnology, crop protection, chemical, food, environmental and consumer products industries. The company was founded in 1961 and has grown to become one of the largest CROs in the world, with over 50 locations in 20 countries. Eurofins Lancaster Laboratories is part of the Eurofins Scientific Group, a global leader in bioanalytical testing and laboratory services. The company's services include method development and validation, stability testing, quality control testing, and regulatory compliance support.
Learn more about Eurofins Lancaster Laboratories
Size
12,000 employees
Industry

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