Kelly Science and Clinical is the world's most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.
This position will be responsible for formulation development of monoclonal antibodies to support preclinical, clinical, and commercial phase of multiple programs. The position has both a hands-on laboratory-based role and requires management of outsourced projects. Formulation development activities include excipient screening and optimization, stability testing and characterization of routes of degradation of proteins in liquid and lyophilized formulations under various stresses. Laboratory activities include buffer and protein solution preparation, pipetting and aseptic operations in a biosafety cabinet. Activities in support of Drug Product manufacturing may be performed, which include mixing studies, process robustness and technology transfer.
- Conduct formulation development and stability studies to support various phase-appropriate antibody drug candidates ensuring compliance with all applicable regulatory guidelines.
- Run routine analytical tests such as size exclusion chromatography, sub-visible particle analysis, icIEF, CE-SDS, CEX-HPLC, viscosity, pH, protein concentration, and appearance.
- Conduct IV/SC compatibility, in-use stability and microbial challenge studies to recommend clinical and commercial dosing strategy
- Develop fit-for-purpose analytical methods to support biophysical characterization, formulation stability, and compatibility testing.
- Review technical transfer documents to support the process development and manufacturing of clinical drug substances and drug products.
- Author formulation development, comparability for process changes, and device or in-use compatibility technical documents to support regulatory filings
- Present work at group, departmental, and cross functional meetings
- Ph.D. degree in Life sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering or a related field with at least two years of experience or master's degree with at least five years of experience is required.
- Experience in formulation development of monoclonal antibodies and novel protein-based molecules, IV admixture compatibility, microbial challenge study, or sterile product development and manufacturing is preferred
- Strong scientific understanding and experience with pharmaceutics, pharmaceutical science, protein chemistry, biophysical/biochemical characterization of proteins, bioanalytical method development.
- Hands-on experience and troubleshooting proficiency with column chromatographic (HPLC/UPLC), electrophoretic, and biophysical techniques (such as DLS, CD, FTIR, DSC, AUC, fluorescence, HIAC, MicroFlow Imaging) for protein characterization
- Demonstrated problem-solving capabilities
- Familiarity with drug product manufacturing and tech transfer support.
- Familiarity with global regulatory CMC documents
- Familiarity with GMPs, manufacturing unit operations, and process validation practices
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.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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