Senior QC Micro Specialist- Cell Therapy (Cambridge, MA)

We are seeking a Senior QC Specialist to join our Quality Control team as a part of our new Regeneron Cell Medicines group. You will be responsible for overseeing contract lab testing and supporting safety testing for novel drug products targeting oncological indications and providing oversight for the testing of release, stability, and routine environmental monitoring samples via contractors. You will play a key role in training and overseeing internal environmental monitoring once brought in-house. Combining your experience in supporting validating and implementing rapid microbial methods with the support of clinical candidates, you will serve as the subject matter expert for environmental monitoring issues to provide technical expertise aligned with current GMPs.

As a Senior QC Specialist, a typical day might include:

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

• 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 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 Bachelors degree and 5+ years of relevant experience. Biopharmaceutical/industry experience in the cell and gene therapy space is strongly preferred. Must have extensive experience with implementing and overseeing an environmental monitoring program. Experience with aseptic processing and microbial testing required. 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 Regenerons proprietary antibodies and bispecifics. We are a group of about 160 research, development, manufacturing and clinical employees based in Seattle, WA and Cambridge, MA.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)