Process Development Specialist/Scientist- DOWNSTREAM

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Job description

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

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.

This position will be responsible for leading and executing the process development strategy for our preclinical and clinical scale candidates in development. The candidate will be expected to work in collaboration with our internal research group as well as our external manufacturing partners to develop scalable and robust manufacturing processes to support manufacture of AAV based gene therapy products. The candidate will have responsibilities for process development at research scale to support our preclinical candidates and GMP scale to support our clinical candidates. The successful candidate will be a subject matter expert in process development for AAV based gene therapy products with demonstrated experience in the field. As an early-stage startup this position will require flexibility, creativity and a can-do attitude to enable efficient execution of company objectives. The level of the position will be commensurate with experience.

Responsibilities:

• Support development of robust, well-characterized, high quality and high yielding upstream production processes for AAV gene therapy products across internal programs.
• Contribute to the design and execution studies to develop a thorough understanding of the process design space, with a view towards technology transfer to a CDMO and successful regulatory filings.
• Prepare and review experimental protocols, provide technical input, and function in the role of technical liaison between CDMO and development group to ensure that sound scientific decisions are implemented.
• Enable execution of discovery and pre-clinical activities through the production of research grade AAV vectors.
• Will be highly communicative and function at a high level in a matrixed management environment.

Minimum Qualification:

• Degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Virology or other relevant discipline. Scientist level applicants should have a PhD OR a master's degree with 5+ years of relevant experience; Senior Scientist level applicants should have a PhD, a post-doc, and 2+ years of relevant experience.
• Expertise in chromatography (affinity and ion exchange), tangential flow filtration, and dead-end filtration
• Good understanding of statistical methods in the application and design of experiments is a plus.
• Excellent written and verbal communications skills, and the ability to present and defend positions and approaches critical to program progression and success.
• Ability to work in a matrix organization in collaboration with discovery research, nonclinical development, operations, clinical development and with consultants and external service providers.
• Work under GLP/GMP to provide high quality, regulatory compliant technical documentation in support of process transfers to manufacturing.
• Aseptic cell culture experience is required.

#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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