Inoculum Prep Lead in Frederick, MD

Description

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, GMP autoclaves, automated cell counting analyzer, automated fill machine and associated equipment relevant to cell culture operations (such as temperature, speed and CO2 controlled incubators, controlled rate freezer and liquid nitrogen freezers).
• Perform basic lab equipment operation and minimal troubleshooting, coordinates equipment calibration and maintenance.
• Ability to train, lead and mentor others within the working group and provides work direction in the Manager's absence.
• Perform production of clinical biological and/or natural products under cGMP conditions.
• Manufacture products and perform in-process testing.
• Assist in the implementation of manufacturing methods, processes, and operations for new or existing products and technologies following cGMP guidelines.
• Formulate raw materials for manufacturing.
• Assist management in the development of schedules and processes.
• Assemble, prepare, operate and clean the equipment used during manufacturing.
• Write, revise and follow Standard Operating Procedures and Batch Production Records under cGMP.
• Document in detail, the processes and manufacturing steps taken during the procedure, using batch production records or laboratory notebooks.
• Complete assigned tasks supporting manufacturing laboratory functions.

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 five (5) years of progressively responsible job-related experience in cGMP manufacturing.
• Must possess basic Microsoft Office skills.
• Working knowledge of cGMPs and computer-assisted manufacturing and production equipment.
• Experience in processes and equipment associated with bacterial and mammalian cell culture.
• Ability to be gown certified.
• Cleanroom experience.
• Ability to lift up to 35 pounds and work in a BL2 environment.
• Ability to obtain and maintain a security clearance.

PHYSICAL REQUIREMENTS

• 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 35lb, 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).
• 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.
• Visual acuity to include depth perception and vision correctable to 20/40.
• Pacemaker prohibited.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Bacterial cell culture experience.
• Mammalian Cell culture experience.
• Experience documenting change controls and deviations.

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.