Description:We are seeking a highly motivated Scientist or Engineer to lead or support the process development of large-molecule biopharmaceuticals. The Scientist will be expected to follow and maintain project timelines and milestones, and design and execute studies to develop process parameters, evaluate limits, assess robustness, and recommend optimum process conditions for downstream purification steps. The Scientist will also be responsible for scaling up the developed steps to pilot and/or manufacturing scale to gain a full understanding of how bench-scale development culminates into viable clinical or commercial processes. The successful candidate will work in high-performing teams, collaborate across technical functions, use sound scientific principles, and ultimately play a critical role in bringing innovative therapies to patients.Responsibilities:Perform purification process development of protein therapeutics (e.g., monoclonal antibodies, fusion proteins, antibody-drug conjugates, etc.), and technology transfer of production processes into GMP manufacturing. Working in teams, planning, and scheduling studies, developing timelines, and creating raw material and equipment usage plans. Design and execute appropriate experiments to evaluate various process conditions using DOEs, analyze, and evaluate data and make sound conclusions based on scientific principles and statistical methodologies. Author technical reports and technical presentations to summarize findings in departmental and cross-functional meetings. Establish appropriate set-points and ranges leading to robust and repeatable process performance.Challenge current paradigm to significantly improve process yields and efficiency through implementing new technologies, optimizing platforms and improved raw materials.Operate automated and semi-automated small and pilot-scale protein purification systems.Utilize high-throughput technologies such as Tecan Liquid Handler, as appropriate.Perform process scale-up to pilot or clinical manufacturing scale equipment using engineering principles. Provide subject-matter expertise and support pilot and clinical manufacturing, as needed.Perform in-process analytical testing using Solo VPE and other technologies.Perform simple product quantity and quality analyses using technologies such as HPLC or UPLC.Bring new technology concepts to couple unit operations, evaluate new chromatography media and assess process analytical technologies.All other duties as assigned.Additional Skills & Qualifications:4 or more years of experience in process development of downstream; hands-on experience with process development studies using bench or pilot scale bioreactors, chromatography systems, and filtration equipment. Experience with downstream purification of monoclonal antibodies or biologics, and operation and maintenance of in-process analytics such as Nova, cell counters, HPLC/UPLC systems, SOLO VPE, AKTA chromatography systems, or other relevant technologies. Experience with technology transfer of purification processes into GMP manufacturingDemonstrated experience authoring technical reports, technical presentations, and conference posters and abstracts. Experience with experiment design, statistical analysis, and data interpretation. Demonstrated ability to handle multiple, simultaneous projects in a fast-paced cross-functional team environment. Experience with the use of engineering principles to perform process scale-up. Knowledge developing connected processes. Experience participating as a departmental representative in cross-functional product development teams. Interest in working for a start-up in transition to a growing product development company, offering opportunities for professional growth.About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
