Qc Specialist- Cell Therapy - Cambridge, United States - Regeneron Pharmaceuticals Inc.

Regeneron Pharmaceuticals Inc.

Verified Company

Cambridge, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

As a QC Specialist, a typical day might include:
Managing the contract testing laboratory for microbial testing of in-process and final product

Overseeing sample collection, shipment, receiving and reviewing test data, and deliver the results internally

Overseeing environmental monitoring contractors for manufacturing suites including ensuring samples are collected at determined frequency, receiving results of sampling, and delivering results internally

Supporting the establishment of rapid microbial method testing for lot release of drug product to support internal clinical manufacturing

Supporting set up, management, and maintaining the Environmental Monitoring program for an internal manufacturing site

Supporting all aspects for microbial testing, from sample receipt and chain of custody through generation of CoTs

Providing expertise to support investigations, deviations and CAPAs

Implementing process improvements to support operational efficiencies

Promoting a culture of Quality and Operational excellence

This role may be for you if you:
Are a highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders (internal and external)

Have demonstrated leadership within teams producing results

Have the ability to communicate effectively in a way that fosters positive relationship building

Have a passion for addressing the critical unmet medical needs of patients

Are self-directed individual who can work in a risk tolerant, fast-paced, innovative environment

In order to be considered for this role, you must have at least a Bachelor's degree and 5+ years of relevant experience.

Biopharmaceutical/industry experience in the cell and gene therapy space is strongly preferred. Must have experience with environmental monitoring, aseptic processing, and microbial testing.

We need someone with a strong understanding of cGMP/ICH/FDA/EU guidance and regulations relating to safety testing of biologics or cell and gene therapies.

Leading activities in microbiology laboratories that support sterile manufacturing required. Experience in site start-up operations is a plus.

Regeneron Cell Medicines (RCM) has been created to advance the next generation of cell therapies and explore combinations with Regeneron's proprietar y antibodies and bispecifics.

We are a group of about 160 research, development, manufacturing and clinical employees based in Seattle, WA and Cambridge, MA.

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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Salary Range (annually) $69, $112,900.00