Project Manager, QA Microbiology
- Employer
- Regeneron Pharmaceuticals Inc
- Location
- Rensselaer County, New York, US
- Salary
- Competitive
- Closing date
- Jun 20, 2021
View more
- Sector
- Consultancy/Private Sector
- Field
- Conservation science
- Discipline
- Biology
- Salary Type
- Salary
- Employment Type
- Full time
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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.
#LI-DF1
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.
#LI-DF1
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