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% of Time Job Function and Description 30 Manage and lead the team for Quality Operations which include the key support functions QC sample management, GMP documentation review, stability sample program management, GMP laboratory systems, and external contract laboratory testing oversight 25 Develop, align, and improve the processes and procedures for and within these key
Posted Today
Describe the essential daily job functions and include % of time spent on each. % of Time Job Function and Description 20% Strategy Development Overall responsibility for all MP&L activities Create and implement best practice MP&L vision, strategy, policies, processes and procedures to aid and improve operational performance (i.e. New materials introduction, implement cha
Posted Today
% of Time Job Function and Description 25 Lead project and manage project, strategic and innovative activities 20 Write, review and/or approve protocols, reports, guidelines, white papers, filing sections (IND/BLA), presentations and tech transfer documents 20 Meetings, preparation and presentations 20 Manage/lead lab activities (study executions, data analysis etc) 15 Ha
Posted Today
The Environmental, Health & Safety (EHS) Technician will be responsible for the day to day management of EHS operations in a laboratory setting. This individual shall partner with Laboratory Management, Facilities, Stakeholders, key vendors, and other supporting function to ensure compliance with Federal, state, and local regulatory requirements and Spark EHS Standards an
Posted Today
Design in vitro and in vivo experiments. Execute experiments on the bench either independently or through teamwork (in house or outsourced). Recording, analyzing and visualizing data; writing study reports; presenting results. Literature review; Identify potential indication targets; co develop plans for evaluating targets. Participate in group meetings and scientific dis
Posted Today
Develop, Support and Execute Spark's Site Engineering operational infrastructure and competencies for the short, medium, and long term needs of the organization and align with Spark's strategic business priorities. Ensure all functional areas are compliant with all relevant regulations and GxP requirements as they relate to site operations. Develop and execute a strategic
Posted 1 day ago
% of Time Job Function and Description 40% In collaboration with regulatory leads and cross functional CMC Teams, this role will lead generation of CMC related submissions and components, including clinical trial applications, marketing applications, regulatory agency briefing packages, and response to regulatory authority queries. Incorporate regulatory strategy and well
Posted 1 day ago
The Sr. Quality Specialist MFG Facilities will be primarily responsible for providing Quality Assurance support for the design/build and startup of a new Gene Therapy manufacturing facility. Primary duties include the following Provide Quality Assurance support for facility design project team, Attend all required project team meetings onsite at design team location and a
Posted 2 days ago
Develop data pipelines and integration solutions by contributing to the existing codebase. Collaborate with different stakeholders to gather requirements, provide insight, and make recommendations as the subject matter expert. Document and present planned projects and deliverables. Education and Experience Requirements B.S in Chemistry, Biology, or Computer Science highly
Posted 3 days ago
% of Time Job Function and Description 50% Design and execute experiments, deliver results for the various development projects. Assemble data sets into reportable and/or presentable formats. 20% Author technical process development reports and any other relevant process documentation (e.g., TT documentation, SOPs, Process Descriptions, Regulatory filing sections, etc.).
Posted 5 days ago
% of Time Job Function and Description 60% Hands on rAAV vector assays, such as vector genomic titer by ddPCR or qPCR, SDS PAGE, Endotoxin, Bioburden, Visual inspection, pH, Osmolality, Spectrophotometry, etc. and assay records. 20% Assay sample management. Prepare laboratory reagents/raw materials for rAAV assays (such as buffers, primers, probes, qPCR standards). Partic
Posted 6 days ago
Manages Data Governance program operations throughoutSpark Ensure appropriate project documentation is compiled and proper review and approvals from respective teams and stakeholders is gathered and collated. Communicate with stakeholders and governance forum members. Education and Experience Requirements B.S. in Computer science, or related field. +8 years of relevant da
Posted 6 days ago
Hire team members to support Project Gateway Safety/EHS, Project Controls, Engineering, Design, Construction, Commissioning, Qualification, Validation and Licensure. The hiring plan will consist of hiring Spark FTE's, contract SME's, and various engineering and equipment firms. Leverage Roche resources where applicable and leverage facility design and equipment standards
Posted 6 days ago
Be a critical and strategic trusted advisor to the Research & Development senior leadership teams to understand, contribute to and enable the function's strategic goals and operational objectives. This includes but is not limited to development of analysis methodologies to drive strategic and tactical decisions; and creation of new tools/solutions for program teams and fu
Posted 6 days ago
Reporting to the Head of Product Strategy, the Senior Administrative Assistant provides administrative support to the Product Strategy organization in a fast paced environment. The primary accountability is to ensure the needs of the executive and the department are prioritized, organized and executed in order to maximize their productivity. This is accomplished by coordi
Posted 7 days ago
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