Job Summary

Salary: Starting at $80-100K.
Overnight Shift Differential: $153.85 bi-weekly

This position is eligible to participate in a bonus plan with a target of 6% of the base salary

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

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. 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.

• 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

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. Supervisory experience preferred.
• 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 Company's primary business language is English. 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.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.