Manufacturing Filling Operations Associate

Company: Frederick National Laboratory for Cancer Research
Location: Frederick
Posted on: March 29, 2026

Job Description:

Manufacturing Filling Operations Associate Job ID: req4503 Employee Type: exempt full-time Division: Vaccine Clinical Materials Program Facility: Frederick: G-WAY Location: 7116 Geoffrey Way, Frederick, MD 21704 USA The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases. Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way. 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 Implements production and large-scale manufacturing procedures to optimize processes and regulatory requirements. Responsibilities include scale-up and troubleshooting for equipment and systems. May establish operating equipment specifications and improve manufacturing techniques. May assist with resolving technical issues, as well as maintenance of production equipment. May review existing operational and process discrepancies in manufacturing and provide technical expertise to improve procedures. Operate basic laboratory equipment such as centrifuges, analytical balance, and portable pipettes. Draft, revise, and 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, 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/controlled rate freezing equipment. Perform filter integrity testing. Operate basic lab equipment, i.e., cGMP autoclaves, high heat ovens, and automated filling equipment. Perform aseptic formulation and filtration. Follow/Review/Revise standard operating procedures. BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency. In addition to the education requirement, a minimum of two (2) years of related experience. Must possess basic Microsoft Office skills. Working knowledge of cGMPs and computer-assisted manufacturing and production equipment. Clean room and BL2 experience. Skills/experience in processes and equipment associated with aseptic formulation/filling machine operation/changeover and operation of packaging/inspection equipment. Ability to be gown certified. Ability to lift up to 50 pounds and work in a BL2 environment. This position may require working on 2nd or 3rd shift and weekends as needed. Ability to write and follow standard operating procedures. Experience in Aseptic formulation and filtration. 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: Experience with isolator technology. Manual and automated filling. VHP decontamination of isolators. 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. Commitment to Non-Discrimination All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws. Pay and Benefits Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here 52,500.00 - 75,221.00 USD The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Keywords: Frederick National Laboratory for Cancer Research, Aspen Hill , Manufacturing Filling Operations Associate, Science, Research & Development , Frederick, Maryland