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OXB · 1 day ago

Senior Analyst, Quality Control

Durham, NC

Full-time

Onsite

Senior Level

5+ years exp

OXB is a quality and innovation-led viral vector CDMO on a mission to enable life-changing therapies to reach patients worldwide. They are seeking a Senior Analyst, Quality Control to establish new commercial-level GMP testing laboratories and perform release and stability testing for gene therapy and immune oncology products.

BiotechnologyGeneticsTherapeutics

No H1B

Responsibilities

Perform cGMP analytical testing (ddPCR, qPCR, ELISA, and chromatography)

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

Lead laboratory deviations and investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as required

Lead, author, perform, review, and/or approve equipment validations with minimal guidance

Implement, lead and/or 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

Participate in providing the necessary information for regulatory filings and inspections

Lead and support CAPA/Continuous Improvement Initiatives

Act as manager designee for quality document review and approval

Qualification

CGMP analytical testingDdPCRQPCRELISAHPLCSOP authoringData integrityAnalytical skillsScientific leadershipOrganizational skillsCommunication skills

Required

BS with 5+ years of experience in a biotechnology discipline

Hands on experience in ddPCR, quantitative PCR, and other bioanalytical methods such as ELISA and HPLC methods

Demonstrate a strong initiative and scientific leadership

Direct experience in authoring and review/approval of SOPs

Superb organizational, analytical, and communications skills and 'do what it takes' attitude

A passion for addressing the critical unmet medical needs of patients

Self-directed individual who can work with limited direction in a fast-paced, goal-oriented environment

Preferred

5+ years of experience in a cGMP/GxP environment

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