Katalyst Pro

Job Title: Data Scientist II Location: Worcester, MA Katalyst CRO Katalyst Pro #Overview: - Design, develop and implement computational pipelines for processing and analyzing spatial omics datasets, including spatial transcriptomics and proteomics. - Collaborate with pathologists and image analysts to develop methods to integrate and analyze spatial transcriptomics data with other spatial modalities, such as #IHC or #mIF. - Collaborate with pathologists to validate spatial analysis tools in the context of tissue structure to ensure accuracy and reproducibility. - Ensure scalability and efficiency of the pipelines to handle large and complex datasets - Ph.D. (or equivalent experience) in Computational Biology, Bioinformatics, Systems Biology, or a related field. - Background in life sciences or experience in the pharmaceutical industry preferred. - Strong proficiency in programming languages such as #Python, #R, or #MATLAB, and relevant data science libraries (such as #NumPy, #Pandas, #Matplotlib, Scikit-learn, etc.) for data analysis, manipulation, and visualization. - Experience with bioinformatics tools and databases, especially those pertinent to omics data analysis such as Squidgy or Scanty. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention MHR #CAPA https://lnkd.in/dAxFyTPW

Job Title: EHS Manager Location: Fremont, CA Katalyst CRO Katalyst Pro #Overview: - Minimum eight to ten (8-10) years of experience in #EHS at an operational facility including five (5) years’ experience with relevant technical subject matter. - Must have significant experience managing and implementing #EHS programs at operational sites on a tactical level. - Will be managing environmental health and safety compliance programs in accordance with all applicable state and federal requirements, and other legal requirements in order to help protect the health and safety of all employees. - Must be fluent in English, with the ability to read, write, and speak the language proficiently for communication, documentation, and customer interaction. - Requires broad knowledge in #EHS regulation’s and in the development and implementation of #EHS management systems. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention MHR #CAPA https://lnkd.in/dDjNA5c4

Job Title: Process Engineer Location: Upper Merion, PA Katalyst CRO Katalyst Pro #Overview: - Minimum Two (2) years of Aseptic Pharmaceutical manufacturing/engineering experience. - Bachelor's degree in chemical engineering, biochemical engineering, mechanical engineering, or related field. - Equipment commissioning and/or qualification experience needed. - Process Safety Management understanding needed. - Assisting in troubleshooting and alarm response to process equipment in clinical pilot plant. - Assess impact of system failures, alarm reports, or planned maintenance activities and identify actions necessary for response to impact. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization #CAPA MHR https://lnkd.in/dRVx28Ya

Job Title: Electrical Engineer Location: Lake Forest, CA Katalyst CRO Katalyst Pro #Overview: - Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development. - Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams. - Capable of performing safety testing and of Client products in the Client safety Lab and external labs. - Prepare documentation to execute safety certification activities – Isolation Diagrams, perform Dielectric and Leakage current testing, Construction evaluation using #IEC generated test reports forms. - Communicate with internal/external labs, technicians, and design engineers to accomplish timely/valuable results at optimal cost (from Quote request to final deliverables). - Collaborate with teams to ensure full execution of identified required testing and review activities needed to ensure product compliance including de-risking product launches through pre-verification test rehearsals. - Provide guidance and requirements to external labs used for certification testing. - Working knowledge of #ISO 14971 Risk Management for Medical Devices in medical device products safety compliance, and/or fully accredited test labs. - Strong familiarity with #EMC test planning and procedures per #IEC 60601-1-2 and associated test practices. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention MHR #CAPA https://lnkd.in/dFTshh2q

Job Title: Engineering Documentation Expert Location: Fort Worth, TX Katalyst CRO Katalyst Pro #Overview: - Develop comprehensive technical documentation, including user manuals, installation guides, labeling materials, and regulatory documentation for ophthalmic devices. - Work closely with engineering, regulatory, and quality teams to ensure all documentation meets industry standards and regulatory requirements. - Interpret engineering drawings and specifications to create detailed build and qualification procedures for complex ophthalmic systems. - Experience in technical writing/documentation for medical devices, particularly in the ophthalmic domain. - Mechanical engineering background with the ability to interpret engineering drawings and system schematics. - Knowledge of medical device labeling regulations and compliance requirements. - Experience with build procedures and qualification processes for complex systems. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention MHR #CAPA https://lnkd.in/da-zrwvc

Position:?Tooling Engineer Location:?Reedsville, PA Katalyst CRO Katalyst Pro #Overview: - Responsible for tooling documentation. - Altering existing drawings. - Replicating tooling. - Releasing tooling into the quality system. - 3+ years of tooling experience. - Strong Solid works experience. - Medical device industry background. - Any foundry or casting experience is a plus. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention MHR #CAPA https://lnkd.in/d3sECUVy

Job Title:?Production Process Engineer Location:?Reedsville, PA Katalyst CRO Katalyst Pro #Overview: - Support planning and execution for a relocation process from Plant A in Shanghai to Plant B in PA. Assess the needs, create detailed planning, ensure facility preparation, equipment disassembly and transport, and reassembly/optimization at new facility. - Initiates Design for Lean Manufacturing in #PDLM processes. - Accountable for Process Requirements based on Product Specifications from I&D and Manufacturing Requirements. - Accountable for process and equipment capability that meets Requirements. - Apply lean manufacturing principles. - Orchestrates design for lean manufacturing with according to inputs to #PDLM workflows. - Responsible for #MF #BOM, routing Master data towards release. - Bachelor's degree or above in Mechanical, Industrial, Manufacturing Engineering, or related field. - 5+ years of experience in manufacturing, product development, or industrial engineering in relevant domains, like consumer electronics products or medical devices. - Proficiency in #CAD software (#SolidWorks, #AutoCAD) and manufacturing simulations. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention MHR #CAPA https://lnkd.in/d6j7B7sJ

Job Title: Scientist I Location: Lake County, IL Katalyst CRO Katalyst Pro #Overview: - Experience in nucleic acid isolation and sample management. - BS degree in Genetics/genomic or related field or equivalent with 3+ years relevant experience. - MS degree in Genetics/Genomics with relevant experience Theoretical and practical knowledge to carry out job function. - Experience with performing routine and or complex nucleic acid workflows from source material such as: cells, tissues, blood, other biofluids. - Experience with performing routine and/or complex nucleic acid quality control and analyzing/interpreting data for, such as, but not limited to fluorescence quantification, absorbance, and integrity analysis. - Experience with low and high throughout sample tracking and data management (#LIMS). - Experience with performing and maintaining workflows on automation platforms. - Experience in a #CLIA certified laboratory or another regulated certified laboratory. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/de3xfH8E

Job Title: CQV Engineer Location: Irvine, CA Katalyst CRO Katalyst Pro #Overview: - The client needs someone with Facilities #CQV experience including #EMPO, Vessel #IOV and #IOPQ including mixing and temp mapping. - They have personnel assigned to Utilities (#WFI, #Alcohol, #N2, Compressed Air, etc.), #CIP, Filter Press, Centrifuge, #CIP skids and Cleaning Validation. - This experience is preferred in case they need additional support. - The project also requires daily job walks of the construction site daily in full #PPE. - BS degree minimum. - 1-4 years of Validation Engineering experience in pharmaceutical industry. - Strong skill set in installation and #IQOQ of equipment like centrifuges, filter presses, and processing tanks. - Very strong technical writing/documentation skills. - Very strong communication skills and ability to coordinate with cross-functional teams. - Experience doing job walks with engineers for capital projects. - Must have a positive attitude and ability to multi-task. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/dSs7bWTK

Job Title: Scientist III Location: Cambridge, MA Katalyst CRO Katalyst Pro #Overview: - Perform in vitro primary cell culture using human #PBMCs, #Cyno #PBMCs, and mouse splenocytes. - Conduct serial dilutions of drug molecules and apply treatments using a multichannel pipette. - Perform Live/Dead and antibody staining of cells. - Conduct #FACS flow cytometry using Client #FACS Canto II, Fortezza, or LSR II and analyze data using FlowJo software. - Perform #ELISA for cytokine analysis and other immunoassays. - PhD in Immunology, Cell Biology, Molecular Biology, or a related field OR Master's degree with 5-7 years of relevant experience. - Strong expertise in primary cell culture, flow cytometry, and immunoassays. - Experience with multicolor flow cytometry panel design and data analysis using FlowJo. - (Preferred) Hands-on experience in #mRNA #LNP production and characterization. - (Preferred) Experience with #LNP antibody conjugation. - Strong analytical, problem-solving, and organizational skills. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/dWB_fwgW