Associate Director, Microbiology

Location
Boulder, CO
Posted
Jul 10, 2020
Ref
20-02240
Required Education
Bachelors Degree
Position Type
Full time

Associate Director, Microbiology
Boulder, CO

Summary
This person will report directly to the Director of Microbiology and must be able to work effectively with the Microbiology Management, Site Leadership and Clients to ensure programs are compliant and staffed appropriately. This person must have a desire to work in an environment managing the diverse activities within the laboratory with a compliance mindset.

Responsibilities
The Microbiology Associate Director will be part of the AFS department responsible for the life cycle management of the Microbiology Programs in support of a contract manufacturing biotechnology facility. This person is accountable for program scheduling, optimization and continuous improvement activities. This person will be responsible and accountable for leading the site's Microbiology Programs by providing technical leadership, daily oversight, and subject matter expertise needed to support the laboratory functions:

  • Staff Management (3-5 Reports that have Direct Reports)
  • Product Support Program
  • Facility Support Program
  • Laboratory Support Program
  • Cleaning & Facility Validation Support
  • Product Development Support
  • Quality Documentation Support

This person must establish and maintain strong partnerships to internal customers, external customers, site management and stake-holders, such as, quality assurance, manufacturing, and facilities and engineering. The person will also represent the Microbiology function in meetings such as the OMT, Review Boards, Client Meetings, and Client Audits

This person is accountable and responsible for driving the maintenance of microbiological programs, quality system documents and metrics that drive compliance, continuous improvement and efficiencies. Additionally, this position is directly responsible for working closely with Area Management to ensure the appropriate level of support and oversight is provided for production and facility activities, as well as project management activities.

Qualifications

  • Exceptional understanding of Quality Systems
  • Qualified Trainer
  • Responsible and accountable for program, procedure and method revisions
  • Oversees Quality Document management
  • Able to approve Quality Documents and CAPA initiation
  • May review and approve microbial control deviations
  • Clear, direct and collaborative communication with team (inter, intra, and client teams)
  • Manage existing programs and continuously improves programs and responsible for program, trending and investigational strategy
  • Escalation and appropriate communication to Microbiology and Site management, in a timely manner
  • Ability to prioritize own work and managers' work with minimum oversight from management
  • Strong understanding of regulatory requirements
  • Ability to coordinate multiple responsibilities and activities simultaneously
  • BS or advanced degree in Microbiology, Biology or related technological field
  • 10+ years of industry experience