Director, Manufacturing Operations
Company: GeoVax Labs, Inc.
Posted on: November 22, 2021
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
- 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
- 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
- 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
- Demonstrated problem detection and problem resolution
- Must possess demonstrated organizational skills.
- Must possess excellent verbal and written skills.
- Orientation of working collegially, focused on striving for
- 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
- Skill in protocol development and study design implementation
- Understanding of cGMP and cGLP manufacturing and testing
criteria, as specified by the appropriate regulatory
- 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
- 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
- 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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