Sr Microbiologist (Validation)
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Rensselaer, New York
- Start date
- Mar 23, 2023
View more
- Discipline
- Science/R&D, Microbiology
- Required Education
- Bachelors Degree
- Position Type
- Contract
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Regeneron is currently looking for a Sr. Microbiologist to join our Quality Control (QC) Validation team. This role is responsible for QC microbiological aspects of cGMP compliance, testing and investigations and will support our manufacturing operations, including our new Fill Finish Facility.
As a Sr. Microbiologist, a typical day might include the following:
- Responsible for QC microbiological aspects of cGMP compliance and testing
- Assist Contract Labs with setting up studies for Disinfectant efficacy and act as a reviewer for the final summary report
- Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed
- Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate
- Participate in cleaning and process validation activities involving microbiology as needed
- Participate in the investigation of microbiological product OOS results and DNF as needed
- Contribute to the preparation of technical proposals, amendments, reports and memoranda
- Contribute toward creating and revising microbiological SOPs
- Assist in scheduling of M/C and post incursion supervising procedures with follow-up responsibility to provide test results
- Assist in the review of EM and product release data
- Have experience with environmental monitoring, endotoxin testing, bioburden testing, aseptic techniques and sterility testing
- Are able to communicate with transparency
- Continuously drive to improve processes for improved performance
- Have experience working in a GMP environment
- Are able to interpret data and develop improvement plan
- Initiate the development of leadership skills by providing training and guidance to others
- Anticipate and plan for change
- Demonstrate analytical skills through critical problem-solving
- Participate in projects in addition to daily responsibilities
To be considered for the Sr. Microbiologist you must have a BS/BA in Biochemistry, Chemistry or Biology or related field and 2+ years of relevant experience, preferably in the pharmaceuticals or biotechnology industries. Experience with pharmaceutical documentation practices and demonstrated leadership experience is preferred.
#LI-MB1
#Hybrid
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually)
$74,300.00 - $121,300.00Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Mini-site
- Regeneron Pharmaceuticals, Inc.
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US
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