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OXB · 1 day ago

Analyst II, Quality Control

Durham, NC

Full-time

Onsite

Mid Level

3+ years exp

OXB is a quality and innovation-led viral vector CDMO focused on enabling life-changing therapies. The Analyst II will support Quality Control functions by conducting analytical testing and ensuring compliance with cGMP standards, playing a vital role in method qualification and validation activities.

BiotechnologyGeneticsTherapeutics

No H1B

Responsibilities

Perform cGMP analytical testing (Cell based Assays, flow cytometry, qPCR, ddPCR, ELISAs, and UPLC)

Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization

Author, review, and/or approve SOPs/policies and technical reports with general guidance

Support laboratory deviations and investigations (IA, OOS, AR)

Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)

Execute phase-appropriate test method validation protocols as needed

Qualification

CGMP analytical testingFlow cytometryQuantitative PCRBioanalytical methodsSOP authoringData integrityLIMSTeamworkCommunicationProblem-solving

Required

BS with 3+ years in a biotechnology discipline

Hands on experience in flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA and UPLC methods

Perform cGMP analytical testing (Cell based Assays, flow cytometry, qPCR, ddPCR, ELISAs, and UPLC)

Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization

Author, review, and/or approve SOPs/policies and technical reports with general guidance

Support laboratory deviations and investigations (IA, OOS, AR)

Execute phase-appropriate test method validation protocols as needed

Preferred

3+ years of experience in a cGMP/GxP environment is preferred

Benefits

Competitive total reward packages

Wellbeing programs that support your mental and physical health

Career development opportunities to help you grow and thrive

Supportive, inclusive, and collaborative culture

State-of-the-art labs and manufacturing facilities

Company

OXB

OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world.

Founded in 1995

Oxford, Oxfordshire, GBR

501-1000 employees