We are currently looking to fill a QA Microbiology Specialist (Drug Substance) position. This position is responsible for leading and being a team member for microbiologically based initiatives. Aspects of training, investigation activities, project implementation, data collection, and coaching will be used. Large percentage of time will be applied observing manufacturing practices with the goal of improving manufacturing procedures. Basic knowledge of biopharmaceuticals and cell culture manufacturing required.

In this role, a typical day might include the following:

• Ability to foster working relationships between multiple Regeneron departmental representatives. Must maintain current knowledge in microbiological practices and methods as they relate to industry and Regeneron expectations.

• Observe manufacturing operations on the floor to provide constructive feedback for strengthening microbial controls and aseptic practices.

• Partner with training team and / or relevant SMEs to develop and deliver training solutions and build capabilities, at site, associated to microbial risk and controls, as well as clean room behaviors and aseptic techniques.

• Aid in investigations pertaining to microbial controls either as a self-directed individual or as part of a group effort.

• Provide advice on technology transfer plans related to microbiological method transfers and new technology.

• Review SOPs, microbiology assay validation, sterilization and related documentation in support of biopharmaceutical manufacturing and testing.

• Provide quality support of API manufacturing with the focus on comprehensive review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.

• Assess the impact of deviation investigations and changes and ensure that all appropriate records are detailed and retrievable.

• Review and provide input on environmental monitoring SOPs and validation.

• Support the work and efforts of QA Microbiology, QC, and Manufacturing training groups.

• Aid in quality audits of CMOs as the microbiology authority and aid in generation of audit reports.

This role may be for you if you:

• Have knowledge of current industry microbial aseptic practices.

• Are able to enter and work in aseptic controlled environments.

• Excel in a quality driven organization

To be considered for this role you must hold a Bachelors degree in Microbiology/Life Science field and the following amount of experience in pharmaceutical/biotechnology or related industry for each level:

• Associate QA Microbiology Specialist – 0-2 years

• QA Microbiology Specialist – 2 years

• Sr QA Microbiology Specialist – 5 years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA