Biologics Raw Materials Group Leader

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

• Bachelors 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.
• Masters degree in a relevant field and three years of directly relevant experience may be substituted for the bachelors degree and experience.
• PhD in a relevant field may be substituted for bachelors 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.

Remote Work :

No

Employment Type :

Full-time