Join an enthusiastic, collaborative team and help contribute to the overall success of their novel gene therapy approach. Our client is seeking an energetic and goal-oriented QC Specialist looking to work within the Quality Sciences and Analytical Technology team. This role is a non-laboratory position that will lead implementation of QC methods used for release testing of autologous stem cell drug products. Previous experience supporting implementation of methods and/or operations required for the manufacture of cell therapies is highly desired.
About the Role:
- Conduct method implementation activities across a diverse CxO network and as part of technical transfers / manufacturing process improvements for cell therapies.
- Own deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results obtained during technical transfers / process improvements
- Conduct Quality Control operational efforts required for technical transfers / process improvements including QC documentation (e.g. sampling plans), shipment, submitting legal contracts and owning POs
- Author and review protocols, technical assessments and reports
- Perform review and statistical analysis of data generated during method lifecycle activities such as method validation, robustness studies and method comparability studies
- Perform gap assessments
- BS/BA in Biology (or related discipline) with at least 3-5 years of experience in a biotechnology discipline
- Experience in GMP/GxP environment as well as an Analytical Development, Manufacturing Sciences or QC unit is required
- Experience with QC activities required for technical transfers or manufacturing process improvements: release testing, method implementation, quality system management
- Proven track record and analytical experience performing mammalian cell culture, flow cytometry, liquid chromatography or mass spectrometry is preferred
- Passionate about working to critical unmet medical needs of patients
- Self-motivated with great organizational, communication and analytical skills and able to work with limited direction in a fast-paced, goal-oriented environment
If you or someone you know in your network is interested in this position, then please send an updated resume to the attention of N.Silvera (AT SIGN) realstaffing.com and her team at Real Staffing Boston.
Sthree US is acting as an Employment Business in relation to this vacancy.