Supervisor, Microbiology

Fresenius Kabi • Melrose Park, IL

1d

About The Position

This position is responsible for supervising the activities of microbiology staff members from Lab Tech II to Lead Scientist levels. The microbiology laboratory consists of four main divisions including the Environmental Monitoring group, the Finished Products group, Aseptic Mentor group and the Methods Validation group, which includes the BFR Laboratory. The principal activities performed vary by which division the supervisor is responsible for, but the expectation is that each supervisor has the necessary background and skills to be responsible for any of the groups. The role involves managing personnel, overseeing laboratory operations, ensuring quality control, and maintaining compliance with regulations.

Requirements

• Bachelor’s degree in the Biological Sciences
• 5 years of progressive laboratory responsibility in support of pharmaceutical manufacturing or equivalent, related industrial or clinical experience.
• Knowledgeable of quality control testing methods, validation techniques and concepts of microbiology.
• Must be able to understand and scientifically interpret data utilizing analytical skills and practical experience in pharmaceutical applications.
• Excellent verbal and written communication skills are essential.
• Planning and organizational skills necessary for primary responsibilities.
• The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Nice To Haves

• Supervisory experience preferred.

Responsibilities

• Responsible for effectively hiring, developing, training, coaching, counseling, managing and motivating staff members.
• Responsible for supervising the activities of microbiology staff members from Lab Tech II to Lead Scientist levels.
• Supervises and schedules daily activities of lead/senior scientists, scientists, associate scientists, mentors and technicians.
• Effectively delegates to assure job objectives are met on a timely basis.
• Hires and oversees the training of department personnel.
• Assures steps are taken to maintain positive personnel morale and development.
• Conducts performance evaluations.
• Oversees microbiology department training of non-departmental personnel in aseptic technique, media fill execution and related topics.
• Assists management with development of training curricula and verifies department personnel maintain a current status on all training requirements.
• Supervises gowning and aseptic technique qualification/requalification program for production employees.
• Assures execution of monitoring and testing programs to assess the microbiology quality parameters of raw materials, components, in-process and finished goods, environmental systems and effectiveness of production processes.
• Establishes and meets goals for the timely release of product and performance of projects such as product transfers, equipment validation.
• Supports all Tech Transfer and I&D Validation activities, filter validation studies and plant equipment qualification and requalification.
• Ensures that a component, raw material, product or an environmental system not meeting specifications or limits is promptly investigated.
• Identifies possible root cause, corrective action needed and evaluates the impact upon the lot.
• Identifies significant adverse quality trends by preparing and analyzing summary reports and key process indicators.
• Addresses quality control test results, microbial profiles of environmental areas, and aseptic behavior.
• Generates new and updates Standard Operating Procedures.
• Ensures timely reviews of existing SOPs are assigned and completed.
• Maintains current knowledge of cGMPs and regulatory issues/guidelines.
• Assures department is equipped with functional, calibrated equipment and necessary supplies.

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage.
• Life insurance
• Disability
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level