Description:
\t\t\t\t\tAssociate Scientist for the Downstream Process Development group. Qualified individuals will be responsible for hands-on execution of downstream chromatography and filtration processes in support of process development, scale-up, process characterization activities, and technical support of cGMP manufacturing for proteins, nanoparticles, and virus-like particle (VLP) based vaccines. The candidate will ensure scientifically sound experimental execution, analysis, and reporting. The candidate will be responsible for drafting technical development reports summarizing critical data. The candidate is expected to be highly self-motivated, well organized, and an innovative thinker focused on execution with a sense of urgency. Essential FunctionsReproduce the downstream chromatography and filtration processes for generation of representative material in support of process development / characterization activitiesComplete scale-up production runs and associated development reports to support technology transfer of process to manufacturing.Maintain and monitor equipment. Propose modifications to processes or equipment to deliver improvements.Assist in implementation of new technologies to improve downstream purification production processes.Participate in the technology transfer of processes to the Manufacturing group and external partners and collaborators. This may include training staff, providing recommendations for equipment to use for scale-up, and directing experiments to troubleshoot and/or support scale-up and cGMP operations.Generate, manage, evaluate, and maintain critical data and records of all process development operations in support of regulatory requirements.Author technical reports, data analysis summaries, and SOP’s as needed. Present scientific findings at internal meetings. Discuss data, draw preliminary conclusions, and design next experiments in conjunction with colleagues and managers.Other duties as assigned.Required Knowledge, Skills, and AbilitiesExperience with small-scale insect and/or mammalian purification process development.Practical experience with small- to mid-scale chromatography systems and tangential flow and normal flow filtration for all typical unit operations used in biomanufacturing.Experience with centrifugation and other cell culture clarification technologies a plus.Excellent verbal, written, and interpersonal communication skills.Excellent troubleshooting skills.Excellent record keeping abilities to adequately record, analyze, and document process development data.Self-motivated with a strong sense of ownership in areas of responsibility and willingness to accept temporary responsibilities outside of initial job description.Ability to work and collaborate in cross functional teams (research, development, and manufacturing) in a fast pace and dynamic team setting with a sense of urgency.High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
\t\t\t\t\tSkills:
\t\t\t\t\tProcess development, Downstream, Chromatography, Filtration, Scale Up, process characterization, GMP, Technology Transfer, Purification, Tangential Flow, VLP, Protein, nanoparticle, Cell Culture, Centrifugation
\t\t\t\t\tTop Skills Details:
\t\t\t\t\tProcess development,Downstream,Chromatography,Filtration,Scale Up,process characterization,GMP,Technology Transfer,Purification,Tangential Flow
\t\t\t\t\tAdditional Skills & Qualifications:
\t\t\t\t\tBS in Bio/Chem Engineering, Biology, Chemistry, Pharmaceutical Science, Biochemistry, biophysics, Molecular Biology, Life Sciences, vaccine development, or a related scientific discipline with 3 plus years of experience, MS degree with 1 plus years of experience in pharmaceutical or biotech companies, or PhD with relevant experience.
\t\t\t\t\tExperience Level:
\t\t\t\t\tIntermediate Level
About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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