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

TN United Kingdom; Cambridge; On-site; GBP 45,000 - 75,000; Full time

Job summary

An innovative firm is seeking a Senior QC Micro Specialist to join their Quality Control team in Cambridge. This role involves overseeing contract lab testing and environmental monitoring for novel drug products, particularly in the field of cell and gene therapy. The ideal candidate will have extensive experience in microbial testing and a strong understanding of regulatory guidelines. You will play a pivotal role in training and implementing rapid microbial methods, contributing significantly to operational efficiencies and quality excellence. Join a dynamic team dedicated to addressing critical medical needs and advancing groundbreaking therapies.

Qualifications

• 5+ years of experience in biopharmaceutical industry, focusing on cell and gene therapy.
• Strong understanding of cGMP/ICH/FDA/EU regulations.

Responsibilities

• Manage contract testing laboratory for microbial testing of products.
• Oversee environmental monitoring contractors and ensure compliance.
• Support rapid microbial method testing for drug product release.

Skills

Environmental Monitoring

Aseptic Processing

Microbial Testing

cGMP Knowledge

Leadership

Communication

Education

Bachelor's Degree

Job description

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

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Client:

Location:

Cambridge, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

5d7e3dc52781

Job Views:

9

Posted:

26.04.2025

Expiry Date:

10.06.2025

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Job Description:

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

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

• Managing the contract testing laboratory for microbial testing of in-process and final products
• Overseeing sample collection, shipment, receiving, reviewing test data, and delivering results internally
• Overseeing environmental monitoring contractors for manufacturing suites, ensuring samples are collected at the determined frequency, receiving sampling results, and delivering results internally
• Supporting the establishment of rapid microbial method testing for lot release of drug products to support internal clinical manufacturing
• Supporting setup, management, and maintenance of the Environmental Monitoring program for an internal manufacturing site
• Supporting all aspects of 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 a 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 is 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 proprietary antibodies and bispecifics. We are a group of about 160 research, development, manufacturing, and clinical employees based in Seattle, WA, and Cambridge, MA.