Manufacturing Associate - Fill/Finish
October 9, 2023
Manufacturing Associate - Fill/Finish
Job ID: req3687
Employee Type: nonexempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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
Reporting to the Supervisor, Manufacturing Filling Operations, this Manufacturing Associate position will:
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills and abilities listed below:
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, 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.
#readytowork
Job ID: req3687
Employee Type: nonexempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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
Reporting to the Supervisor, Manufacturing Filling Operations, this Manufacturing Associate position will:
- 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
- Basic Microsoft Office skills
- Ability to be gown certified
- Cleanroom and BL2 experience
- Ability to lift up to 35 pounds and work in a BL2 environment
- Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Manual and automated filling experience
- 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
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, 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.
#readytowork