The Manager of QA Microbiology will lead a team for microbiologically based initiatives within the drug substance side of manufacturing. Aspects of training, investigation activities, project implementation, data collection, and mentoring will be included in the day to day activities of this position. Some time will be applied observing manufacturing and Quality Control Microbiology Laboratory practices with the goal of improving manufacturing procedures associated with those functions.
As a Manager of QA Microbiology a typical day might include the following:
- Ability to champion working relationships between multiple Regeneron departmental representatives. Must maintain current knowledge in microbiological practices and methods as they relate to industry and Regeneron expectations;
- Lead teams for common company objectives and projects as needed.
- Observe manufacturing operations on the floor to provide constructive feedback for strengthening microbial controls and aseptic practices;
- Aid in investigations pertaining to microbial controls either as a self-directed individual or as part of a group effort;
- Supply information on technology transfer plans related to microbiological method transfers and new technology;
- Review and provide input on SOPs, microbiology assay validation, sterilization and related documentation in support of biopharmaceutical manufacturing and testing in addition to environmental monitoring SOPs and validation;
- Support the work and efforts of the QA Microbiology, QC, and Manufacturing training groups;
- Aid in quality audits of CMOs as the microbiology SME, providing guidance and aid in generation of audit reports;
- Perform managerial duties including, but not limited to, performance evaluations, 30/30s, time sheets, coaching/guiding new hires, PIPs and other duties
- Some domestic and foreign travel required
This role may be for you if you have:
- Knowledge of current industry microbial aseptic practices required.
- Ability to enter and work in aseptic controlled environments is required.
- Device and filling experience preferred but not required.
- Basic knowledge of Biopharmaceuticals and cell culture manufacturing required.
To be considered for this role you must hold a Bachelors Degree in Microbiology or Life Science field and
- Associate Manager: 6 years relevant experience in the pharmaceutical/biotechnology or related industry with at least 2 years in a leadership role
- Manager: 7 years relevant experience in the pharmaceutical/biotechnology or related industry with at least 2 years in a leadership role
- Master’s degree in Microbiology preferred. Relevant experience may be considered in lieu of the educational requirement.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.