Job Title

Reporting directly to the Analytical Development (AD) and Testing Lead, the Analytical Development (AD) and Testing Senior Analyst will support the management of the life cycle of analytical development for in-process, release and stability program testing of raw materials, plasmids, cell/bacterial banks, drug substance and drug products, in support of discovery, development, and manufacturing of iECURE's product portfolio from the clinic through commercial launch.The following information provides an overview of the skills, qualities, and qualifications needed for this role.This individual will be active, technical, collaborative, a critical thinker with project management skills, who can work effectively with the founding scientific team at Penn's Gene Therapy Program (GTP) and contract partners. This individual will provide input and support global regulatory submissions for the Chemistry, Manufacturing and Controls (CMC) package into the clinic through commercial under the stewardship of iECURE. The Senior Analyst will be a seasoned professional who has supported, executed, and helped define analytical development and testing strategy associated with all phases of drug development, including the coordination and preparation of document packages for regulatory submissions. This individual will have strong experience dealing with the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide. Characteristics sought for a good cultural fit to the company include the ability to work collaboratively, strong project management skills, excellent planning and budgeting skills, ability to think strategically and act independently, a "hands on" approach in the implementation of an agreed-upon plan, nimble problem-solving skills, an innate sense of urgency, creative thinking about what is possible in execution, and general positivity.ResponsibilitiesManage the development, verification, qualification, and validation of analytical methods inclusive of assay relevance, reproducibility, reliability, robustness, and optimization.Provide strong scientific background in implementation of molecular biology assays, microbiological safety assays, compendial methods and have deep understanding of phase appropriate method verification, qualification, validation, sample and data analysis, GLP, GMP requirements, ICH and FDA guidance.Work with CDMOs in technical transfer, design, method development, bridging, comparability, and validation employing phase appropriate approaches at the different stages of development for assay test articles. Support the development and execute an approach for characterization to support identification of CPP/CQAs and define the control strategy.  Support the development of process analytical technology (PAT) to design, define, analyze, and control the manufacturing process.Be responsible for CDMO scheduling, sample plans and management, test articles/procedures, personnel training, test execution, results and troubleshooting analytical method issues and lab investigation/deviations during QC testing.Provide in-process manufacturing as person-in-plant and QA batch release.Provide input, draft and review of analytical related technical studies, gap analyses, risk assessments, methods/articles, protocols, memos, data, impact assessments, and reports.Support clinical assay development and help manage the operations and execution of clinical assays at CROs.Support the oversight of the stability program and ensure it supports regulatory objectives and timelines.Help prepare the CMC sections for regulatory filings. Participate in the preparation, assembly and filing of CMC regulatory submissions to support development stage and new product approvals, including interactions between the company and health authority representatives to facilitate submissions. Assist in the submission and resolution of agency related questions.Remain at the forefront of the relevant science and competitive landscape including new analytical technologies.Build a collaborative working relationship with Penn GTP's CMC organization and provide guidance on analytical development and testing activities to produce the most efficient and effective outcomes possible for iECURE.Collaborate with Technical Operations and other internal functions to ensure the management of all financial aspects of manufacturing activities including budgeting/forecasting, long-range planning, quantitative decision making, and overall cost management and accountability of product supply, in relation to CMC activities. QualificationsBS/BA degree in Science.An advanced degree is desired, such as a PhD or MS, in chemistry, biochemistry, or a relevant discipline.7+ years of experience in the biotech industry, and experience in all stages of biological CMC development.Knowledge and experience in gene therapy and gene editing in AAV manufacturing are preferred. Knowledgeable in analytical techniques such as NGS, AUC, PCR, cell-based potency, ELISA, HPLC, MS, DLS and compendial methods.Experience with clinical assays is desired.Strategic/forward-thinker and CMC technical experience. Experience in a successful project participant role supporting the development, supply, and registration of candidate drugs through market approval. Experience interacting with regulatory agencies, specifically with the FDA and international regulatory authorities. Proven track record of successfully participating in technology transfer of projects. Experience in developing and scaling manufacturing, with a stellar track record interacting with third parties and CDMOs to produce the highest quality drug products for patients.Familiarity with line management and project management, embracing budgets and timelines to deliver on commitments made. Demonstrable experience of working hands-on with limited resources.Ability to understand the strategic, big-picture level to be effective when delving into details to successfully deliver project goals.Positive attitude and change agent capable of working with others in a matrix environment.Proficient at approaching problems/risks/issues with professionalism, confidence, and decisiveness with the ability to provide resolutions.Possess outstanding presentation, oral and written communication skills, as well as an enthusiastic and open attitude toward learning and continuing professional development. A commitment to excellence and continuous quality & efficiency improvements.Able to manage local and national travel, with up to 20% travel to vendor sites.Ability to work and support holidays, weekends, and off hours, as needed.LocationFulltime, based in Blue Bell, PAiECURE is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.