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Biopharmaceutical Manufacturing Associate - Fill/Finish

Employer
Frederick National Laboratory for Cancer Research
Location
Frederick, MD
Start date
Nov 7, 2023

View more

Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital

Job Details

Biopharmaceutical Manufacturing Associate - Fill/Finish

Job ID: req3733
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 Bachelor’s degree in a scientific related field from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in cGMP aseptic fill/finish manufacturing operations in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • No work experience required with a Bachelors degree
  • Must possess 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
  • 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

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

Company

A rewarding career with global impact

Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.

Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.

We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.

Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.

Discover why joining the Frederick National Laboratory team could be the most important career step you take

 

 

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Company info
Website
Telephone
301-846-1000
Location
8560 Progress Drive
Frederick
MD
21701
US

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