Manufacturing Associate I, Filling Operations

About the role

The Vaccine Clinical Materials Program (VCMP) at the Frederick National Laboratory supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). The program operates a pilot plant facility and is involved in cGMP manufacture, release, and supply of Phase I/II clinical products for investigational use.

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 processes and manufacturing steps through Production Batch Records or laboratory notebooks.
• 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 sing.
• Draft and revise Standard Operating Procedures, Master Batch Records, and Component Specifications.
• Maintain inventory of supplies and components used in the manufacturing process.

Qualifications

• Possession of a Bachelor’s degree from an accredited college or university in a scientific related field (or 4 years’ experience in cGMP aseptic fill/finish manufacturing operations).
• 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

• 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.
• Respond to verbal instruction and cues in a sterile environment where staff are wearing face masks.
• Wear Personal Protective Equipment (PPE).
• Visual acuity to include depth perception, color distinction, and vision correctable to 20/40.
• Enter a laboratory or encounter a hazardous area.
• Operate and/or service equipment that contacts or transports compressed or liquid gas.
• Withstand exposure to temperatures below 32 degrees indoors for small amounts of time.
• Pacemaker prohibited.

Jobs Hazards

This position involves working with or having the potential for exposure to infectious material, requiring medical clearance and immunizations.

Pay and Benefits

The posted pay range for this job is $43,800.00 - $62,702.00 USD. Additional factors such as responsibilities, education, experience, knowledge, skills, abilities, internal equity, and market data are considered in extending offers.