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RoslinCT · 2 weeks ago

Scientist, Microbiology

Hopkinton, MA

Full-time

Onsite

Mid Level

$77K/yr - $115K/yr

4+ years exp

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. The Scientist, Microbiology will be responsible for authoring and reviewing microbiology methods, ensuring compliance with regulatory requirements, and supporting QC operations as a subject matter expert. This role involves collaboration with cross-functional teams and the preparation of technical data for senior leadership.

BiotechnologyClinical TrialsManufacturing

Hiring Manager

Stacy Adams Coburn

Responsibilities

Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements

Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring

Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance

Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations

Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods

Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed

Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management

Ability to prepare technical data and present to senior leadership

Qualification

Microbiology methodsCGMP QC laboratory experienceEnvironmental monitoringTechnical data presentationContamination controlTraining developmentEffective communication