MSAT Process Engineer - Permanent

Job description

Kelly Science & Clinical has a new, permanent opportunity for an MSAT Process Engineer in Gaithersburg, MD. Relocation assistance is provided!

Day-to-Day Responsibilities:

+ Support scale-up and scale-down processes for gene therapeutics

+ Contribute to design, development, and execution of characterization studies

+ Serve as CMC technical lead and collaborate with cross-functional teams to perform process risk assessments

+ Utilize JMP Statistics software for Design of Experiment (DoE) and data analysis

+ Author, review, and revise technical CMC documents

+ Other tasks as needed

You are a great fit if you meet the following qualifications:

+ BS/MS in Life Sciences

+ Must have at least 5 years of late-stage biologics development

+ Must have above average communication skills, written and verbal

+ Subject matter expert with FDA, EMA, GMP, and ICH regulatory requirements

+ Experience with quality by design (QbD) and JMP statistical software

+ Expertise with biologics process characterization and validation - given priority

+ Experience with bioreactors, chromatography, filtration, and various analytical methods - given priority

+ Must be authorized to work in the US

This position will work Monday - Friday from 8:30am - 5:00pm. Salary will range between $95k-$145k, based on relevant years of experience. If you, or someone you know, would like to be considered please apply online today to discuss next steps!

**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.

**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 (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. ()