Manufacturing Associate I, Filling Operations

PROGRAM DESCRIPTION The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its’ mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally. KEY ROLES/RESPONSIBILITIES Complete assigned tasks supporting manufacturing laboratory functions. Perform aseptic techniques to maintain bacterial and mammalian cell cultures. Utilize CO2 incubators and a Biosafety Cabinet to maintain, manipulate and propagate cultures. Operate basic laboratory equipment such as analytical balance, portable pipettes, autoclaves, and depyrogenation ovens, automated filling equipment, and barrier isolators. Follow Standard Operating Procedures (SOP). Complete batch production records under current Good Manufacturing Practices (cGMP). Perform aseptic gowning. Document, in detail, through the use of Production Batch Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures. Perform drug product component preparation. Perform aseptic formulation, filtration, 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. Draft and revise Standard Operating Procedures, Master Batch Records, and Component Specifications. Maintain inventory of supplies and components used in the manufacturing process. BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a scientific related field (Qualifying four (4) years’ experience in cGMP aseptic fill/finish manufacturing operations 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 possess basic Microsoft Office skills. Ability to be gown certified. Ability to work in a BL2 environment. Ability to obtain and maintain a security clearance. PHYSICAL QUALIFICATIONS Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms and legs, use of all fingers, lift/carry up to 50lb, reach above shoulders, climb ladders, push/pull, bend repeatedly, and stand for extended periods. Ability to respond to verbal instruction and cues in a sterile environment where staff are wearing face masks. Ability to wear Personal Protective Equipment (PPE). Visual acuity to include depth perception, color distinction, and vision correctable to 20/40. Ability to Enter a Laboratory or Encounter a Hazardous Area. Ability to Operate and/or service equipment that contacts or transports compressed or liquid gas. Ability to withstand exposure to temperatures below 32 degrees indoors for small amounts of time. Pacemaker prohibited. PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Cleanroom and BL2 experience. Manual and automated filling. Aseptic isolator operation. Aseptic technique performed in Biological Safety Cabinets (BSC). 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. JOB HAZARDS This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.