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Director, Manufacturing Operations

Company: GeoVax Labs, Inc.
Location: Washington
Posted on: November 22, 2021

Job Description:

GeoVax is seeking an individual experienced in viral vector manufacturing and process development to lead the Company transition into manufacturing processes and operations in conjunction with CDMO strategic relationships as the Company advances multiple clinical development programs. Position Summary: Primary responsibilities include overseeing external manufacturing relationships and activities with Contract Development Manufacturing Organizations (CDMOs), including the development, implementation, direction, documentation and oversight of viral vector manufacturing process development and operations. Additional responsibilities include drafting and reviewing Standard Operating Procedure documents, technical transfer and oversight of production processes with external contractors, internal general laboratory management and interactions with Research and Quality systems staff. This position reports into the CEO.
Critical roles and activities:

  • Responsible for maintaining effective relationships with external manufacturing CDMO's on the day-to-day operational planning and execution activities.
  • Screen potential contract manufacturers, organize technical transfer of process and implement on large scale for GMP clinical production. Oversee the performance and support of contracted CDMO relationships.
  • Support Product/Process Development and Manufacturing areas to ensure a smooth transfer of technologies and products to CDMOs. Working with the CMC team, provide effective mitigation and escalation strategies for project risks and CMC issues. Interact with program core teams to ensure alignment of CMC plan with overall program strategy, and the requirements drug supplies
  • Monitor project scope, milestones, dependencies, and costs associated with CDMO project and the timelines for all CDMO deliverables.
  • Manage short and long-term project commitments for product supply and communicate levels to internal project teams.
  • Development of new and improved processes/techniques in viral vector production and purification.
  • Optimize upstream production conditions for maximum yield both in small bench-top experiments and in scale-up trials for future clinical and commercial production of vaccine components.
  • Optimize and characterize downstream process recovery and purification of methods centrifugation, ultrafiltration, chromatography, and other suitable methods. Maximize recovery of viral vector products, minimize cell substrate contaminants, ensure purity and potency of product.
  • Transfer of biological materials within US or abroad - knowledge and compliance with IATA and USDA shipment requirements including those of importation and exportation.
  • Assist in oversight of clinical product production, formulation, fill/finish, release and stability testing.
  • Assist in the development and execution of GLP release testing of in-process, bulk harvest, and formulated viral vector product.
  • Assist in legal documentation draft and revision, when related to contract services, including MTA, CDA, License Agreements, Manufacturing and Testing services.
    • Require minimum BS degree, MSc or PhD preferred, in biology, microbiology, biochemical engineering or related field.
    • 10 or more years experience in Upstream and/or Downstream Vaccine Process Development, GMP manufacture, cell culture, viral vector production and/or virology.
    • Strong independent judgement and decision-making abilities.
    • Demonstrated problem detection and problem resolution skills.
    • Must possess demonstrated organizational skills.
    • Must possess excellent verbal and written skills.
    • Orientation of working collegially, focused on striving for excellence.
    • Committed to Right-First-Time; consistently achieving the highest level of Quality in Company performance.
      Knowledge, Skills and Abilities: ---
      • Proficient theoretical and working knowledge in biological fermentation processes and bioreactor instrumentation design and operation.
      • Skill in protocol development and study design implementation is essential.
      • Understanding of cGMP and cGLP manufacturing and testing criteria, as specified by the appropriate regulatory authorities.
      • Experimental design, protocol development, and process optimization: Individual must evaluate the limitations of current processes, devise new ideas for yield efficiency improvement, design experiments to test these ideas, carry out experiments, evaluate results, and invent new ideas in a continual cycle of process improvement.
      • Participation in meetings with regulatory council and agencies for use of existing and optimized processes in compliance with cGMP manufacturing methods and existing standards for viral vector products.
      • Occasional travel required to off-site contract locations in order to assist in supervision of manufacture, fill/finish and release steps for clinical product; occasional travel to scientific conferences and seminars.

Keywords: GeoVax Labs, Inc., Washington DC , Director, Manufacturing Operations, Executive , Washington, DC

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