Inoculum Prep Lead

Location
Frederick, MD
Posted
Nov 21, 2018
Ref
req177
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 Inoculum Prep, this position will:
  • Complete assigned tasks supporting manufacturing laboratory functions
  • Perform production of clinical biological and/or natural products under cGMP conditions
  • Manufacture products and performs in-process testing
  • Assist in the implementation and manufacturing methods, processes and operations for new or existing products and technologies following cGMP guidelines
  • Formulate raw materials for manufacturing
  • Assist management in the development of schedules and processes
  • Assemble, prepare, operate and clean the equipment used during manufacturing
  • Write, revise and follow Standard Operating Procedures and Batch Production Records under cGMP
  • Document in detail, the processes and manufacturing steps taken during the procedure, through the use of batch production records or laboratory notebooks
  • Operate, GMP autoclaves, automated cell counting analyzer, automated fill machine and associated equipment relevant to cell culture operations
  • Perform basic lab equipment operation and minimal troubleshooting, coordinates equipment calibration and maintenance
  • Ability to train, lead and mentor others within the working group and provides work direction in the Manager's absence

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
  • Working knowledge of cGMPs and computer-assisted manufacturing and production equipment
  • Experience in processes and equipment associated with bacterial and mammalian cell culture
  • Ability to be gown certified
  • Cleanroom experience
  • 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
  • Bacterial cell culture experience
  • Mammalian Cell culture experience
  • Experience documenting change controls and deviations

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)