OXB
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Join Us in Changing Lives Location: Durham, NC, US Company: oxfordbiom
About OXB OXB is a quality and innovation‑led viral vector CDMO 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 30 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 (AAV) 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.
Senior Analyst I – QC Bioassay We’re currently recruiting for a Senior Analyst I – QC Bioassay to join our Quality Control team. In this role, you will establish new commercial‑level in‑house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products, playing a key part in advancing our mission and making a real difference.
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.
Qualifications
BS with 5+ years of experience in a biotechnology discipline.
5+ years of experience in a cGMP/GxP environment is preferred.
Hands‑on experience in ddPCR, quantitative PCR, and other bioanalytical methods such as ELISA and HPLC.
Demonstrated strong initiative and scientific leadership.
Direct experience in authoring and reviewing/approving SOPs.
Superb organizational, analytical, and communication skills and a "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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
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
A company that lives its values: Responsible, Responsive, Resilient, Respect.
Ready to Make a Difference? We want you to feel inspired every day. At OXB, we’re future‑focused and growing fast. We succeed together—through passion, commitment, and teamwork.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
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Join Us in Changing Lives Location: Durham, NC, US Company: oxfordbiom
About OXB OXB is a quality and innovation‑led viral vector CDMO 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 30 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 (AAV) 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.
Senior Analyst I – QC Bioassay We’re currently recruiting for a Senior Analyst I – QC Bioassay to join our Quality Control team. In this role, you will establish new commercial‑level in‑house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products, playing a key part in advancing our mission and making a real difference.
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.
Qualifications
BS with 5+ years of experience in a biotechnology discipline.
5+ years of experience in a cGMP/GxP environment is preferred.
Hands‑on experience in ddPCR, quantitative PCR, and other bioanalytical methods such as ELISA and HPLC.
Demonstrated strong initiative and scientific leadership.
Direct experience in authoring and reviewing/approving SOPs.
Superb organizational, analytical, and communication skills and a "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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
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
A company that lives its values: Responsible, Responsive, Resilient, Respect.
Ready to Make a Difference? We want you to feel inspired every day. At OXB, we’re future‑focused and growing fast. We succeed together—through passion, commitment, and teamwork.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr