Fermentation Lead

Location
Frederick, MD
Posted
Nov 12, 2018
Ref
req165
Hotbed
BioCapital
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.

KEY ROLES/RESPONSIBILITIES

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


BASIC QUALIFICATIONS

 

  • 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)