Director of Downstream Process Development
Company: Kelly Services
Posted on: April 9, 2021
Job Title: Director of Downstream Process DevelopmentLocation:
Durham, North CarolinaSalary: DoEJOB SUMMARY:
- Manage staff in Downstream Process Development.
- Responsible for day to day technical supervision of the
downstream scientists and associates.-- Serve as in-house advisor
on key scientific discipline areas.
- Be an expert in downstream process technologies. Innovate and
spearhead development of downstream process technologies that can
result in significant increases in efficiency and purity.
- Operate within a cross-functional project team environment and
coordinate efforts with all relevant internal functional areas
including Quality, Manufacturing, Upstream Process Development,
Program Management, Analytical Development, Formulation
- Have direct experience with establishing downstream processes
for biologics in cGMP manufacturing settings.
- Guide staff in building scalability attributes into downstream
- Experience throughout the biopharmaceutical product life cycle
including process characterization studies, in-process control
strategy and process validation.
- Coach and develop a highly talented and motivated staff
- Experience in operating in a client driven environment and
communicating results and strategies cogently to a diverse
- Full responsibility for the direction of all downstream process
- Evaluate, develop and implement new downstream technologies
leading to process improvements and efficiency of operation or
enable company to showcase the excellence of our development
operations. Publish papers in leading journals and present at key
industry conferences as applicable.
- Assist in attracting new clients to company through presenting
and showcasing KBl's technical and scientific capabilities as they
apply to potential client projects. Support the development of
appropriate proposals by interfacing with Business
- Create working plans within DSP team to manage program load and
resources & equipment.
- Develop and maintain budgets, manpower and capital requirements
for downstream process development and manufacturing areas. Develop
and monitor performance criteria to allow measurement and
continuous improvement of efficiency and quality, thereby ensuring
meeting of committed targets of on-time and error-free
- Lead, assess, coach, and develop departmental associates.
Manage performance; ensure team meets expectations and meets
objectives; guide the professional growth of team members by
providing personal guidance and training relative to
- Assure cGMP success through effective tech transfer and support
of cGMP manufacturing. Coordinate efforts with manufacturing to
achieve program success.
- Determine areas for gaining efficiency, coordinate with
individual groups and ensure harmonized implementation of best
- Document all activities according to the appropriate laboratory
procedure and/or standard operating procedures.--MINIMUM
REQUIREMENTS: Minimum requirement is a Bachelor of Science degree
in a scientific discipline with a minimum of 15 years of technical
management experience; a Master's degree with 13 years or a
Doctorate degree in a scientific or biochemical engineering area
(or equivalent) and at least 8 years related experience and/or
training preferred. Additionally, at least 5 years' experience
serving in a relevant managerial capacity required.
- Must have knowledge of GMPs and biotechnology-derived product
- Also requires a demonstrated track record in the following key
- Knowledge of downstream process development for biologics
- Ability to multi-task and handle successful execution of
multiple parallel programs
- Knowledge of cGMP and manufacturing operations
- Knowledge of tech transfer
- Knowledge of good lab practices including hands on
- Knowledge of regulatory guidelines, particularly those for IND
filing.#TJP2021_SPEC Why Kelly--?Kelly Science & Clinical is your
connection to premier scientific and clinical companies looking to
hire talented people just like you. Every day, we match science
professionals with dream jobs that fit their skills and
interests-it's the way we think job searching should be. Nearly 100
percent of our science recruiters have a professional
background/education in science, so we know a thing or two about
the science market and how to get you noticed.About Kelly--At
Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world. Kelly is
an equal opportunity employer committed to employing a diverse
workforce, including, but not limited to, minorities, females,
individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
Keywords: Kelly Services, Raleigh , Director of Downstream Process Development, Executive , Raleigh, North Carolina
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