Senior Quality Control Analyst

We use science to save lives, and so can youWe are currently recruiting for a Senior Analyst I/II to support our Quality Control (QC) team. The position will be primarily responsible for executing routine GMP testing of cell-based potency and molecular assays while collaborating cross-functionally on quality systems, such as OOS/OOT investigations, deviations, change controls, and risk assessments, as well as participates in qualification and validation of analytical test methods.The OXB QC department performs testing to support GMP release and stability testing for gene therapy products such as but not limited to ddPCR, RT-qPCR, ELISA, flow cytometry, HPLC, CE, AUC, and compendial assays (e.g. Bioburden, Endotoxin, TOC, Conductivity). Additionally, the QC department performs routine environmental, utility and water monitoring in the GMP manufacturing facility located at Bedford, MA.This onsite role is based in Bedford, MA. Come join the team, and let's do something life-changing, together!Your responsibilities in this role would be:Performs routine QC GMP testing including, but not limited to: ddPCR, RT-qPCR, ELISA, flow cytometry, HPLC, CE, AUC, and compendial assays.Authors and revises SOPs/forms and other relevant controlled documentation.Performs peer review of both internal and externally generated data.Supports execution of method qualification protocols as needed.Trains and mentors junior QC staff.Supports routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management).Ensures laboratory operational readiness and assists with troubleshooting/continuous improvements as needed.Ensures all tasks are performed in a manner consistent with safety standards.Provides support during client audits and internal audits as a QC SME.We are looking for:Bachelor's or master's degree in life sciences, engineering, or equivalent.Minimum 5 years of GMP experience in the biotech or pharmaceutical industry.Experience with lab investigations, deviations, CAPAs, change controls, and risk assessments.Experience with data review and presenting results to functional management.Hands on experience in cGMP environment.Proficiency in molecular aseptic techniques as well as passaging and banking multiple analytical cell types.Experience with key analytical equipment (e.g., ddPCR, qPCR, ELISA, flow cytometry, HPLC, CE).Independently motivated, detail oriented and strong problem-solving ability.Able to work effectively in a collaborative team environment.About Us:OXB is a quality and innovation-led viral vector CDMO (Contract Development and Manufacturing Organization) with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus, and adenoviral vectors. OXB's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.What's in it for you:Competitive reward packagesDevelopment opportunitiesWelcoming, friendly, supportive colleaguesA diverse and inclusive working environmentState of the art laboratory and manufacturing facilitiesAt Oxford Biomedica (US) LLC we are committed to providing equal opportunity to all employees and applicants. Our policy is to recruit, hire, train, and reward employees for their individual abilities, achievements, and experience without regard to race, color, religion, sexual orientation, age, national origin, disability, marital or military status.This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.Collaborate. Contribute. Change lives

Created: 2025-01-26