Fermentation Lead

Frederick, MD
Nov 12, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.


Reporting to the Manager of Fermentation, this position will:

  • Support manufacturing laboratory functions
  • Maintain bacterial and mammalian cell cultures
  • Operate/troubleshoot single use and fixed stainless steel bioreactors, benchtop lab equipment, GMP autoclaves, and other associated equipment
  • Follow standard operating procedures
  • Complete batch production records under current good manufacturing practices
  • Document in detail, through the use of batch production records, the processes and manufacturing steps taken during the procedures
  • Lead production activities in the manufacturing area
  • Train others within the working group and provide feedback to the manager
  • Interface with quality control/quality assurance
  • Interact with customers and/or senior management
  • Write/revise sops
  • Perform investigations and write deviations



  • Possession of a Bachelor's degree in a related field from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education).
  • Minimum five (5) years progressively responsible job related experience or three (3) years progressively responsible job related experience in a cGMP environment
  • Experience with cGMP cell culture manufacturing and production equipment
  • Ability to troubleshoot cell culture process and associated equipment, especially experience with bioreactors
  • Ability to assist in complex investigations including root cause analysis and corrective action determination
  • Working knowledge of cGMP's as they relate to manufacturing operations
  • Ability to write and follow standard operating procedures
  • Ability to assist in writing master batch records and complete Batch Production Records under Good Manufacturing Practices
  • Ability to be gown certified
  • Cleanroom and BL2 experience
  • Ability to lift up to 35 pounds and work in a BL2 environment
  • Must be able to obtain and maintain a security clearance

Expected Competencies:



  • Career-level (fully competent) experienced professional able to carry out a full range of professional duties, by working independently and receiving minimal guidance
  • Provides professional know-how to enhance the knowledge and skill base of the group
  • Accountable for meeting own target which will impact the group
  • Impact is limited to the achievement of short- to medium-term goals
  • Contributes to delivery of department goals through personal effort or through influence over team members
  • In-depth knowledge of principles and practices within the discipline
  • Uses best practices and knowledge of internal or external business issues to improve products or services and suggests variations in approach
  • Devises solutions based on limited information and uses past experience, evaluation, and interpretation to identify solutions or to adapt existing approaches to resolve issues; which may impact the longer term
  • Solves complex problems; takes a new perspective using existing solutions
  • Requires strong multicultural awareness to appropriately deliver messages and adapts style to differing audiences
  • Acts as a resource for colleagues with less experience; may direct the work of other staff members

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