Process Development Specialist/Scientist- UPSTREAM

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Job description

Kelly ® Science & Clinical is seeking Process Development Specialist/Scientist- UPSTREAM

professionals who are eager to bring the latest scientific discoveries to life in order to create a brighter, safer and healthier future for all. If you're passionate about shaping the world we live in and ready for a new challenge, this may be the perfect opportunity for you.

The position will be responsible for employing and validating robust cellular and viral growth processes for transfer into a manufacturing setting, media evaluation, development and optimization of both cellular and viral production processes, conducting and interpreting bioprocess small-scale development experiments, and maintaining appropriate GLP documentation in support of global regulatory submissions for vaccine licensure. This position will require to work under GLP/GMP to provide high quality, regulatory compliant technical documentation in support of process transfers to manufacturing.

Responsibilities:

• Performs advanced project management support for developing and working with onsite and offsite colleagues and to work independently.
• Employs and validates robust cellular and viral growth processes for transfer into a manufacturing setting.
• Responsible for media evaluation, development and optimization of both cellular and viral production processes.
• Conducts and interpreting bioprocess small-scale development experiments for Zoetis projects.
• This position will have experience with bioreactor production systems including disposable single use reactors.
• Maintains appropriate GLP documentation in support of global regulatory submissions for vaccine licensure.
• Provides support to bio-process downstream and analytical scientists.
• Works both with onsite and offsite colleagues and to work independently.
• Plan, and organize R&D projects and establish the required procedures to be applied to those projects.
• Defines problems and provide possible solutions as dictated by R&D projects and protocols.
• Develop and modify equipment and applications as required to accomplish project goals,
• Train and supervise research staff as needed.
• Coordinate and provide technical direction to research staff to ensure effective and cost-efficient completion of projects if needed.
• Provide technical knowledge to research staff to ensure they can complete their assignments,
• Recommend new areas of research and development that support the goals and objectives of our department.
• Analyze, interpret, compile and report project results to a PI and/or department head.
• Serve as a technical liaison between the Cell and Viral Process Development and other partner groups such as Discovery, Clinical, Pilot, Manufacturing and Regulatory.
• Provide finished oral and written communication reports to supervisor and management.
• Work under GLP/GMP to provide high quality, regulatory compliant technical documentation in support of process transfers to manufacturing, and responsible for later stage development and transfer of robust process to Pilot as well as Commercial Production.
• Develops and disseminates work plans and project documents to include procedures, proposals, progress reports, and presentations.
• Prepares and reviews proposals, SOPs, BPRs, reports, QC/QA related documents.
• Maintenance of appropriate documentation for tests, research and development as specified by our department and required laws and regulations.

Minimum Qualification:

• BS in biology-related field with 5+ years' experience.
• PhD in biology-related field with 2+ years' experience.
• Microbiology, or Virology degree.
• Expertise in aseptic techniques and the handling and maintenance of mammalian cell lines.
• Experience with cell culture and cell line propagation as well as experience working in a BSL-2 laboratory.
• Knowledge of mammalian cell line development, and nutritional metabolite evaluation.
• Experience with media evaluation, development and optimization.
• Experience with basic molecular biology techniques.
• Ability to multi-task and work cooperatively with others.
• Experience working with diverse individuals and communities.
• Experience in animal health vaccinology.
• Experience with virus propagation and viral process development
• Experience with DOEs and the use of biometrics in bioprocess study design and evaluation.
• Experience with disposable production equipment (e.g., wave reactor systems, S.U.B. reactor systems)
• Experience with cell transfection.
• Knowledge of regulatory issues associated with USDA and EU biologics submissions.
• Knowledge of GxPs, including Process validation.
• Master seed production and working knowledge of GMP seed procedures.
• Proven record of strong communication and teamwork skills.

• Ability to design and analyze multi-factorial biometric experiments.

#TJP2021_SPEC

#TJP2021_SCT

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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.

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 (plus, did we mention we provide a ton of benefits ?). 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 Law.

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