Manufacturing Associate III or IV

Location
Frederick, MD, USA
Posted
Nov 06, 2018
Ref
req153
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
The Biopharmaceutical Development Program (BDP) supports the National Cancer Institute (NCI) through the development of novel agents for first-in-human clinical studies.

KEY ROLES/RESPONSIBILITIES

The Manufacturing Associate III or IV will:
  • All phases of production (e.g., fermentation, purification, etc.) Of clinical, biological and natural products under CGMP conditions
  • Document in detail, through the use of master production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
  • Exercise judgment and use problem solving skills to obtain solutions and work independently to determine methods and procedures on new assignments
  • Train others within the working group
  • Set up, maintain and operate equipment used in the manufacture of clinical, biological and natural products, including the manufacture of products and in-process testing
  • Interface with quality control/quality assurance
  • Write standard operating procedures and complete batch production records

BASIC QUALIFICATIONS:

Basic Qualifications for Manufacturing Associate III:
  • Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirements, a minimum of five (5) years of experience is required

Basic Qualifications for Manufacturing Associate IV:
  • Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirements, a minimum of eight (8) years of experience is required

Both Levels will need:
  • Demonstrated experience in the area of operating/maintaining computerized and complex production equipment
  • Experience writing/reviewing technical documents, SOPs and master production records and maintaining accurate documentation of laboratory procedures in accordance with cGMP
  • Working knowledge of cGMP Biopharmaceutical Sciences and operations and department specific computer applications
  • Ability to work flexible hours including occasional weekends
  • Ability to lift up to 35 pounds and work in a BL2 environment
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Experience with large-scale bacterial fermentation equipment and systems
  • Experience with large scale chromatography equipment and systems
  • Experience in virus production/purification
  • Experience with technical transfer of GMP production processes
  • Ability to perform in-process tests such as gel electrophoresis, HPLC, etc.

Expected Competencies:
  • Aseptic technique

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)