Scientist II, Downstream Process Development

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What will you do?Contribute to multiple projects and participate in the planning and execution of process development and scale up activities (both bench and pilot scale).Serve as functional SME and work collaboratively with other team members on all aspects of downstream execution for viral vector processes.Participate and/or lead the training and development of other team members.Prepare and modify documents (development plans, batch records, SOPs, protocols, summary reports).Identify technical gaps/facility fit challenges for new clients/processesSupport analytical testing for process development and characterization.Lead Practical Process Improvement (PPI) initiativesHow will you get here?EducationB.S. in Chemical Engineering, Biochemistry, Biology or related field with 3+ yrs, of experience or Masters degree.Experience Design and execution of downstream unit operations Have understanding of experimental design and be able to independently execute laboratory experiments. Strong hands-on experience with different purification techniques such as affinity and anion exchange chromatography and associated instrumentation such as AKTA chromatography systems and Unicorn software. Experience with depth filtration design and sizing including manifold assemblies. Design and execute DOE studies high-throughput screening for purification process improvements including parameter optimization, scale-up, and buffer selection. Viral reduction filtration and support for viral clearance studies. Has completed tangential flow filtration along with final formulation for virus, and plasmid DNA-based gene therapies. Scale-up of downstream processes, supports process characterization and validation activities. Effective problem solving and troubleshooting abilities. Collaborating with Upstream and Analytical Testing/Development teams to build process understanding and design and execution of in-process testing and control assaysKnowledge, Skills, Abilities Working level knowledge of downstream purification of mammalian and insect cell culture processes Experience in scale up and scale down of purification processes. Ability to analyze and summarize scientific data Understanding of cGMP and regulatory requirements of biopharmaceutical manufacturing. Strong interpersonal and communications skills; written and oral Ability to function in a rapidly changing environment handle multiple priorities. A flexible work schedule is required including Weekend and night as needed to support lab activities.Please use the below link for job application and quicker responsehttps://lifelancer.com/jobs/view/84ec60ea52021f936e747358d0d6aa7b

16 April 2024
Location: United States Catalonia Plainville
Work type:
Full time
PLEASE! No enquiries from Recruitment Agencies or Headhunters.

Only direct applications will be considered.

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