1+ months

Associate Scientist, Process Development

Kelly Services
Seattle, WA 98194
Kelly Science is the worlds most recognized brand in Scientific Staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of products that are used daily in the home, such as medical devices or pharmaceutical products. The successful candidate must be detail orientated and work independently within a highly collaborative and fast-paced environment.


The Associate Scientist role is a hands-on position and plays an integral part in planning, design of experiments, and the daily execution of Downstream Process Development functions. The primary role will be to support development of a robust and scalable purification process to manufacture protein therapeutics supporting first-in-human clinical trials. The ideal candidate will have experience with operating bench scale purification instruments, utilizing multiple chromatography modes, characterizing purification processes.

**Responsibilities** :

+ Operation of purification equipment (program purification methods, execute purification, and collecting and presenting purification data)

+ Detailed planning of experiments in collaboration within the Process Development group and other groups. Participation in the planning of project timelines, deliverables, and milestones

+ Authoring and/or reviewing SOPs, batch records, production protocols, deviation assessments, technical reports for GMPs and CMC sections of regulatory filings

+ Preparation of buffers and other purification solutions appropriate to scale


+ A bachelors or masters degree in Biochemistry, Bioengineering, Biology or related fields is required.

+ Three or one years of relevant industry experience required for the bachelors or masters levels, respectively.

+ Experience in developing, charactering, and validating purification unit operations tangential flow filtration steps, or complete downstream processes for recombinant protein therapeutics

+ Have transferred and scaled-up purification process to CMO for clinical production of recombinant therapeutic proteins.

+ Demonstrated ability to design and execute scale-down model qualifications and viral safety validation studies

+ Familiar with utilizing basic protein science analytical tools: UV280 protein concentration determination, SDS-PAGE, HPLC

+ Ability to operate filtration systems and troubleshoot downstream issues.

+ Experience in design of experiments (DoE), analysis of results, authorship of technical reports and presentations for both internal and external uses.

+ Knowledge of cGMPs and regulatory requirements for therapeutic biologics.

**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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 Law. (
Posted: 2020-12-25 Expires: 2021-02-25

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Associate Scientist, Process Development

Kelly Services
Seattle, WA 98194

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