Associate Director, Manufacturing

Paragon Bioservices   •  

Harmans, MD

Industry: Pharmaceuticals & Biotech


11 - 15 years

Posted 53 days ago

The Associate Director, Manufacturing for the Upstream Processing group is responsible to lead teams while overseeing the GMP manufacturing process, through the broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial systems for Phase I/II GMP manufacturing.

Key Responsibilities include but are not limited to:

  • Responsible for managing multiple teams of Supervisors, Team Leads & Associates across multiple campaigns and shifts
  • Oversight of upstream production operation for cell culture or microbial processes
  • Ensures the successful technical transfer of projects from the Tech transfer group to the GMP production group
  • Works closely with the production staff to troubleshoot process and equipment problems
  • May create, revise, and edit SOP, SMPs, and specs as needed
  • Actively participates in all recruiting efforts to secure, onboard and develop new staff members
  • Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improve and production records
  • Generates operational protocol(s) and production records
  • Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives
  • Will overview PD materials, equipment, methods for GMP compliance and scalability
  • Expands the technical capabilities of the GMP Group
  • Effectively communicates results of departmental work through team discussions and documentation Other duties as assigned
  • Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns
  • Recommends equipment, supply purchases within the production areas

Skills & Behaviors:

  • Has considerable knowledge/expertise relevant to fundamental lab technologies, particularly focused on protein expression, isolation and analysis
  • Has excellent understanding and knowledge of microbial fermentation, centrifugation, operations of reactors and TFF processes OR Have excellent understanding and knowledge of cell culture techniques and processes, experienced in using disposable single-use bioreactors (WAVES, Xcellerex)
  • Has demonstrated track record of managing hands-on cGMP manufacturing operations
  • Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules
  • Ability to produce successful results in a fast-paced environment, under minimal supervision while leading a team of professional production associates
  • Creative individual with excellent troubleshooting skills as they relate to scientific and engineering principles

Experience & Education:

  • HS Diploma or Associates Degree & 14 years of GMP biologic manufacturing experience OR B.S. in Engineering or Science discipline and 12+ years of GMP biologic manufacturing experience OR M.S. in Engineering in a Science discipline plus 10+ years of GMP biologic manufacturing experience. Some or all of this experience should be in upstream processing.
  • Microbial: Experience with microbial (bacteria, yeast) production & fermentation processes to produce bulk biologics (proteins, polysaccharides, antibodies, etc.) OR Cell Culture: cell culture techniques and processes, experienced in using disposable single-use bioreactors (WAVES, Xcellerex) required
  • Minimum of 6 years of leadership experience required (HS Diploma/Assoc degree); 4 years leadership (Bachelor or Master’s degree).

Requisition ID : 1305