Kelly Services is currently seeking a DIRECT HIRE Principal Scientist of Downstream Process Development for an esteemed client located in Research Triangle Park, NC. Seeking a highly motivated purification process leader (Principle Scientist / Associate Director) with biopharmaceutical industry experience to develop, optimize, and characterize downstream processes. This role will lead a team in Downstream Process Development (DSPD) department.
The focus of this position is on purification process development for antibodies, Fc fusions, bispecifics, vaccines, and other protein molecules, as well as on optimization of various conjugation chemistries and purification processes.
Direct Hire + Benefits + Bonus Eligible + Relocation Assistance
The ideal candidate will have:
- The ability to directly and indirectly contribute to between 40-50 programs a year
- Ability to maintain a high level of expertise through review of scientific literature and attendance at conferences.
- Willingness to provide hands-on operation of equipment if needed and train team members on lab operations
- Excellent working track record, including hands-on experience with protein purification via chromatography and filtration-based methods.
- Experience with statistical design of experiment (DOE) is a plus.
- Drive purification process development strategies for a wide variety of molecular modalities in both early and late stages, as well as initiate and lead technology development projects.
- Partner with the overall downstream team, upstream team, Analytical Development, Formulation Development, Manufacturing and MS, and Program Management
- Launch and expand, lead, and manage a team of process development scientists and associates for downstream process development
- Establish and build state-of-the-art downstream tools and capabilities, for example, expanding high throughput downstream process development, as well as improve existing platform approaches.
- Likely to be selected (as a development assignment) to be an Integrated Development Leader responsible for multiple projects from one client that includes coordination of efforts of team members and across departments, acting as spokesperson to interact positively and productively with clients, and advising management on program status.
- Design, implement, and interpret experiment data as well as providing guidance to team members.
- Support process scale-up activities in the pilot plant and clinical and commercial manufacturing sites.
- Communicate downstream process development capabilities to prospective clients as well as work with existing clients to identify technical solutions and escalate risks appropriately
- Maintain awareness of current process control strategies, critical parameter identification and assessment as applied to downstream operations.
- Support commercialization of molecules with a focus on the transition from late-stage-development to launch as well as post-approval lifecycle management
- Degree in Chemical/Biochemical Engineering, Biochemistry or equivalent
- Masters with 10+ years or Ph.D. with 6+ years of biopharmaceutical industry experience in downstream process development
- Excellent oral and written communication skills.
Apply Today for Immediate Consideration!
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