Please note that this is a 1 year contract position.
• Liaise with QA Account Managers and Contractors to obtain Drug Substance(DS) and Drug Product (DP) Certificates of Analysis and prepare for submission to internal Regulatory Affairs group at the time of lot release
• Maintain highlevel oversight of all DS and DP lots manufactured throughout the US production network
o Responsible for tracking cell bank and seed lots, DS and DP lot IDs, lot initiation dates, lot completion dates, status, disposition, lots subject to investigation and reasoning/status etc.
o Compile information and package for review with Regulatory Affairs group for quarterly submission to the FDA CBER (Center for Biologics Evaluation and Research) through the IND (Investigational New Drug) program
• Provide support to NCL/OMCL team in answering the questions of internal Regulatory Affairs group and the FDA CBER
• Manage and track sample shipment from Contract manufacturers (CMOs) to NCL/OMCLs (national control laboratory/official medicines control laboratory)
• Offer support in the event a samples shipment is subject to investigation or anomalous results are produced
• Develop and execute lot release protocol(s) for submission to health agencies
• Complete and pass all applicable training required for access to quality and information management systems (i.e. ETS Trackwise, eLIMS etc.)
• Complete and pass all applicable Good Manufacturing Practice training and general quality management training Learning and remaining current with FDA and local regulations, guidelines and quality practices associated with the vaccines industry is required
*This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
Experience / Knowledge Required:
• Bachelor’s Degree in engineering, science, or an equivalent technical discipline
• Minimum of 4 years working in an FDAregulated environment, preferably in a pharmaceutical or biologics manufacturing environment
• Basic understanding of of aseptic processing principles
• Proficiency in computer applications such as Microsoft Office Suite
• Must have strong ability to maintain high efficiencies and accuracy in data entry
• Detailoriented, with ability to quickly process complex information and make critical decisions with limited information at times
• Strong interpersonal, written, and oral communication skills
Experience / Knowledge Preferred:
• Experience in the CBER/OMCL process for vaccine government approval/release
• Previous experience in work environment under cGMP regulation highly desirable
• Experience in Vaccine Production/QA
• Proficient in applying process excellence tools and methodologies
• Experience working with external manufacturers or laboratories
• Advanced degrees are a plus and may reduce the experience required
Applicants must provide their phone number. Reference job number A478.