Project Manager, QA Microbiology

4 days left

Regeneron Pharmaceuticals Inc
Rensselaer County, New York, US
Jun 08, 2021
Jun 18, 2021
Employment Type
Full time
Salary Type
We are currently looking to fill a Project Manager, QA Microbiology position. This position focuses on all microbial aspects supporting final Drug Product (DP) manufacturing by Regeneron Pharmaceuticals, validation activities, contamination controls, clean utilities, process and environmental monitoring, fill simulations and all aspect of controlling and investigating microbial aspect of the fill finish operations

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

Resolve problems, identify trends and decide system improvements

Develop working relationships between multiple Regeneron departmental representatives

Implement change when vital within the guidelines of GMP

Support the review of microbial control related documents, including but not limited to, SOPs, Validation and Qualification documentation, Study Protocols, and Investigations

Maintain project timelines associated with department initiatives to support the evolving business

Responsible for all logistics associated with regulatory inspections with QA Microbiology

Attend meetings relevant to assigned projects as needed

Supervise internal findings and communicate updates, metrics and outstanding items to senior personnel

Project support may span into operations, validation and inspection management

Maintain consistency of Microbial programs and initiatives across multiple sites through procedures and facility education of personnel

Assist in quality audits of CMOs as the microbiology specialist, offering feedback and aid in generation of audit reports

This role may be for you if you:

Excel in a quality driven organization

Are able to enter and work in aseptic controlled environments

Have experience/understanding if aseptic fill finish operations, including all types of in process monitoring criteria and microbial controls

Enjoy maintaining current knowledge in microbiological practices and methods as they relate to industry and Regeneron expectations

To be considered for this role you must hold a Bachelor's degree in Life Sciences or related field and following minimum amounts of relevant experience for each level:

Associate Project Manager - 8+ years

Project Manager - 10+ years

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.


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