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Research Associate

A Pharmaceutical Company is seeking a Research Associate in Frederick, MD. Role Description This role will provide process engineering and analytical support for commercial manufacturing of cell therapy. Working cross functionally with quality, operations, material management, facility and engineering functions, the role is expected to provide technical input for product/process response and investigations, technology implementation, technology transfers, process validation and regulatory filings. • Execute scientific laboratory studies to support process/product understanding and continuous improvement projects • Execute analytical testing of cell therapy products – flow cytometry, ELISA and PCR assays. • Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench • Provide technical input to the execution of process validation and comparability campaigns. • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing • Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation. • Participate and report to a cross-functional team to advance production activities. • Participate in Operational Excellence activities within Tier Structure. • Participate continuous improvement projects supporting commercial manufacturing site • Ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing. • Support technology transfers of launch and commercial cell therapy products • Effectively & efficiently communicate manufacturing process performance internally. • Support the implementation of automation and IT infrastructure projects • Assist in writing technical documentation (protocols & reports for equipment/instrument qualifications, comparability, and cell therapy manufacturing process validation) Skills & Requirements • Bachelors Degree in Biochemical Engineering, Tumor Immunology, Biotechnology or Life Sciences. • Basic understanding in Bioprocessing, Cell Culture and Biochemistry. • Knowledge of ELISA and/or PCR testing • Knowledge in flow cytometry and data analysis (FACSDiva, FlowJo, GraphPad Prism, Excel) is a plus • Ability to think critically, demonstrate troubleshooting and problem-solving skills • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment • Previous experience with other technologies is a plus • Experience with the use of Microsoft word, Excel, Power Point, Smartsheet, Prism, JMP, and other data analysis applications • Highly collaborative with excellent interpersonal, verbal and written communication skills • Ability to think critically with demonstrated problem-solving and troubleshooting skills • Comfortable working in a fast-paced company environment with minimal direction and able to adjust workload/assignments based upon changing priorities • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description

HAYS PLC • Frederick, U.S.

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Research Scientist

JOB SUMMARY: Conduct biological research associated with one or more complex projects within the NASA Ames Research Center’s Bioengineering Branch. Primary focus will be on designing, building, and analyzing a microbiology experiment for the International Space Station (ISS). The goal of the experiment is to complete multi-omics analysis of Arthrospira platensis during 6-months of continuous photoautotrophic growth. BASIC REQUIREMENTS: ● Master's degree from an accredited university in a biological discipline with 3+ years’ professional experience or a Doctoral degree with 0-3 years’ of experience. ● Laboratory experience in genomics, molecular biology, microbiology/plant biology, biochemistry/analytical chemistry, omics sample preparation, and omics data analysis. ● Familiarity with best practices for working with hazardous materials and willingness to adhere to NASA-defined processes. ● Experience with Microsoft Office and command line computer operating systems such as Linux, Unix, or R. ● Ability to communicate effectively with scientists, engineers, and external scientific service providers from a wide range of technical backgrounds. ● Excellent written and verbal communication skills as well as analytical problem-solving abilities. ● Track record of communicating scientific results through conference presentations and peer-reviewed journal articles. ● Capacity to work independently and efficiently with minimal instruction. ● Demonstrated ability to work in a team environment. ESSENTIAL FUNCTIONS: ● Complete experimental research to determine spaceflight experiment design requirements, develop/build the flight payload, and prepare samples for omics analysis. ● Support science components of flight operations that may require travel and/or extended hours. ● Conceive and design laboratory experiments and actively participate in project planning. ● Generate, record, analyze, and compile experimental data. ● Complete statistical analysis of whole genome sequences, transcriptome sequences, proteomics, and metabolomics data. ● Submit data to appropriate public databases. ● Prepare figures for presentation/publication and collaborate with other scientists in publishing research findings. ● Draft scientific materials for public outreach and/or publication. ● Present research at scientific conferences. ● Maintain a safe and organized laboratory area. ● Perform laboratory duties including management of materials and supplies, equipment, and operations. ● Identify materials and equipment needed for experiments, obtain product information, identify vendors, and assist in the preparation of material and supply acquisition. ● Oversee general state of the laboratory, including scheduled waste removal, decontamination of surfaces, and instrument calibration/upkeep. ● Carry out assigned duties in a manner consistent with defined safety policies and report any safety incidents, potential hazards, or close calls. Assist with identifying and eliminating any unsafe conditions.

Careerbuilder • Mountain View, U.S.

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Lipid Nanoparticle Scientist

A Pharmaceutical Company is seeking a Lipid Nanoparticle Scientist in San Diego, CA. Role Description The successful candidate will design, manufacture and characterize lipid nanoparticles for the delivery of nucleic acids as well as other novel nanoparticle-based drug delivery formulations containing small molecules, RNA, DNA and proteins. The work is multi-functional and includes formulation design, analytical methods development, physical characterization, experimental design, sample analysis and interpretation of results. The candidate with be expected to bring prior experience in the field and interact closely with other researchers in the design of lipid nanoparticle delivery formulations. This is a hands-on, laboratory-based role in a highly collaborative early development environment. Job Description: • Must have experience with lipid nanoparticle delivery of RNA or DNA for transfection to mammalian cells or in-vivo models. • Must have experience in nanoparticle formulation and nanoparticle drug delivery. • Must have experience in development of methods to analyze and characterize nanoparticle formulations, components and functionality. • Background in the biology of gene transfection and expression is a plus. • Experience and technical proficiency with HPLC and other methods for analysis and quantification of small molecules, DNA and proteins is preferred. • Previous experience and technical proficiency in the physical characterization of nanoparticles, including particle sizing is a plus. • Familiarity with lab-scale nanoparticle preparation techniques, including microfluidics technology, is preferred. • Experience with alternate pharmaceutical manufacturing technologies homogenization, lyophilization, micronization, etc. is a plus. • Strong interpersonal, communication, collaboration and problem solving skills. • Ability to document work and proven record of scientific technical writing. Skills & Requirements • Qualifications: Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Biomedical Engineering or closely-related discipline with an emphasis in delivery of nucleic acids. M.S. or B.S. in similar fields acceptable with a minimum of 6+ years of relevant industrial experience.

HAYS PLC • San Diego, U.S.

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