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Principal Scientist/Associate Director

Company: BioPhase Solutions Inc.
Location: San Diego
Posted on: October 20, 2018

Job Description:

Principal Scientist/Associate Director, Purification Process Development\

Summary:We are seeking an independent, experienced, and self-motivated senior level Scientist to be a key member of a dynamic and fast-paced organization. The successful candidate will provide hands-on leadership to develop stage appropriate purification processes used for pre-clinical and clinical production of therapeutic proteins.

Responsibilities:

Lead the downstream process development team to design, execute, and document laboratory studies for purification process development and for protein production at various scales, including hands-on bench activities.Pplay an active role in process technology transfer and supporting tox and clinical manufacturing at contract development and manufacturing organizations (CDMOs).The successful candidate must be a goal-oriented team player with excellent troubleshooting and communication skills and adaptive to a timeline driven work environment.

Requirements:

Ph.D in Biochemistry, Biochemical Engineering, or related field with 12+ yrs industry experience in developing protein/antibody purification processes to support pre-clinical and clinical stage programs. Experience in production of antibody drug conjugate is highly preferred.Experience in leading a purification process development team and overseeing GMP manufacturing is required.Both hands-on experience and scientific knowledge in modern protein purification techniques (chromatography, clarification/filtration, ultrafiltration/diafiltration, and conjugation) are required.Hands-on experience in programming and operating chromatography systems, TFF systems, as well as column packing and evaluation at various scales are also required.Working knowledge and hands-on experience in implementing basic analytical techniques (gel electrophoresis, HPLC and protein assays) for protein quantitation and characterization are required.Experience in purification process characterization, scale-up, technology transfer to CDMO, including drafting development reports, production batch records, protocols etc., to support clinical manufacturing is highly desired.Experience in process development and optimization using statistical tools (DOE and data analysis) is a plus.Must be self-motivated, detail-oriented, collaborative, and able to work effectively in a fast-paced environment with minimal supervision.Excellent communication, organization, and collaborative skills are essential.

Keywords: BioPhase Solutions Inc., Pasadena , Principal Scientist/Associate Director, Executive , San Diego, California

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