Fill Finish Associate

The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.

KEY ROLES/RESPONSIBILITIES

Reporting to the Supervisor of Fill/Finish, this position will:

• Perform drug product component preparation
• Perform aseptic formulation and filling and controlled rate freezing
• Perform inspection and labeling activities under current Good Manufacturing Practices (cGMPs)
• Perform operation and changeover of filling machines and associated equipment
• Set up and operate inspection/labeling equipment
• Perform filter integrity testing
• Operate advanced buffer/media skid, cGMP autoclaves and basic lab equipment
• Weigh raw materials
• Perform buffer preparation/formulation
• Perform aseptic gowning
• Follow standard operating procedures
• Complete Batch Production Records under cGMP
• Document, in detail, through the use of Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree in a related field from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
• No experience is required with a Bachelor's degree
• Must be able to obtain and maintain a security clearance
• Ability to be gown certified
• Cleanroom and BL2 experience
• Ability to lift up to 35 pounds and work in a BL2 environment

PREFERRED QUALIFICATIONS

• Manual and automated filling
• Aseptic Isolator operation
• VHP decontamination of isolators
• Lyophilization/freeze drying
• Formulation/ buffer preparation
• Filter integrity testing
• Labeling/packaging
• Ability to interface with Quality Control, Quality Assurance, Materials Management

Expected Competencies:

• Entry role, contributing in a support capacity by receiving instruction, guidance and direction from others
• Accountable for meeting own targets which impact the immediate work area
• Impact is limited to short-term team performance
• Responsible for planning own work, assessing own progress, and adjusting efforts to meet goals
• Applied knowledge of standardized rules, procedures, and operations within own area
• Determines a course of action based on guidelines and competence developed by performing structured work assignments
• Uses existing procedures to solve routine or standard problems, and occasionally requires basic problem solving techniques to define problems
• Generally knowledgeable about the subject matter but may be required to interpret or clarify technical information to aid understanding

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)