The Microbiology Department is hiring!
We are currently looking to fill a Senior Quality Assurance Microbiology Specialist
. This position leads microbiologically based initiatives, surrounding drug product manufacturing, bulk/API and our newly established fill finish facility. Aspects of training, investigation activities, project implementation, data collection, and collaboration with other departments will be applied. Large percentage of time will involve observing manufacturing practices with the goal of improving manufacturing procedures.
In this role, a typical day might include the following:
This role may be for you if you:
- Developing 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
- Aid in investigations pertaining to microbial controls either as a self-directed individual or as part of a group effort
- Provide input 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
- Review 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 specialist
- Have knowledge of biopharmaceuticals and cell culture manufacturing required
- Are knowledgeable of current industry microbial aseptic practices
- Are able to enter and work in aseptic controlled environments
- Have device and filling experience
- Have experience in project leadership
To be considered for this role you must hold a Bachelor's degree in the Microbiology/Life Science field and
- 2+ years of proven experience for a Specialist in the pharmaceutical/biotechnology or related industry
- 5+ years of proven experience for a Senior Specialist in the pharmaceutical/biotechnology or related industry
- May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
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 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 maternity 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.