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JOIN OUR TEAM.
We follow the science that will lead us to the best possible outcomes for patients.
Mission
We are a mutation-agnostic in vivo gene editing company striving to cure liver disorders with high unmet needs by harnessing new advancements in genetic medicine. Our in vivo insertion methods knock in healthy copies of disease-causing genes, offering long-term, stable expression of those genes in patients.
Culture
Our science is at the leading edge, and so are we. Our team of experts is here to transform lives and bring potentially curative treatments to patients in need. Great work takes a deep level of collaboration at all levels, and we strive every day to foster an environment that inspires innovation, execution and an unrelenting commitment to patients.
We are built on the world-class translational engine at the University of Pennsylvania’s Gene Therapy Program (UPenn GTP). The work executed by this group of world‑renowned gene therapy experts on our pipeline provides a substantial developmental head start – meaning treatments in the hands of patients as quickly as possible.
Work With Us
Interested in joining our team of genetic medicine experts?
Please email careers@iecure.com to learn more, and browse our current job openings below.
No current openings.
Manager, Manufacturing Sciences & Technology – Downstream
Position Summary:
Reporting to the Manufacturing Sciences & Technology (MS&T) Lead, the MS&T – Downstream Manager will support the life cycle management of iECURE’s vector manufacturing process in support of discovery, development, and manufacturing of iECURE’s product portfolio from the clinic through commercial launch.
The MS&T Downstream Manager will provide pivotal support throughout the execution of downstream process development and cGMP vector production activities. This individual will be responsible for overseeing downstream process development and manufacturing production activities at contract manufacturing organizations to support timely product delivery.
This individual will be active, technical, collaborative, a critical thinker with project management skills, who can establish relationships and work effectively with iECURE’s manufacturing partners. This individual will also support global regulatory submissions and the Chemistry, Manufacturing and Controls (CMC) package into the clinic through commercial under the stewardship of iECURE.
The MS&T Downstream Manager will be a seasoned professional with a strong background in downstream purification techniques and processes, who has also supported, executed and helped define material and process control strategies associated with all phases of drug development, including the coordination and preparation of document packages to support regulatory submissions.
Characteristics sought for a good cultural fit to the company include the ability to work collaboratively, excellent project management, planning and budgeting skills, the 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.
Specific Responsibilities
- Possess a strong scientific background and in-depth understanding of downstream manufacturing processes in an effort to implement, facilitate and manage phase-appropriate process development activities, including new product introduction, clinical development studies, design of experimental plans, process characterization and validation readiness.
- Establish and foster strong collaborative relationships with external manufacturing partners and service providers.
- Provide technical guidance and support on all phases of process development, testing and manufacturing activities to produce highly efficient and effective outcomes for iECURE, Inc.
- Work closely with CDMOs to create, schedule, and manage project plans and associated milestones and deliverables to completion.
- Serve as the primary point of contact for and person-in-plant (PIP) at iECURE, Inc.’s manufacturing partners, providing on-the-floor technical and scientific support during technical transfer, characterization, pilot, and manufacturing activities.
- Collaborate with CDMO partners to troubleshoot and solve process-related issues within the manufacturing facility in real-time, coordinating with appropriate teams to resolve problems and prevent recurrence.
- Work closely with the appropriate internal and external team members to identify and qualify GMP raw materials, set specifications, create and review batch records. Oversee the preparation of cell culture medias, solutions, and buffers to be used in GMP manufacturing.
- Provide input on, draft and review studies, gap analyses, risk assessments, master records, protocols, memos, data, change controls, impact assessments, deviations, CAPAs and reports.
- Perform facility fit activities including process flow diagram (PFD) generation, scale up calculations, defining equipment and solution requirements, and generation bill of materials (BOM) and new specifications, as required).
- Support the technical development, validation, and continued verification of the manufacturing process inclusive of optimization, reproducibility, reliability, robustness, and improvements related to yield and product quality.
- Assist in the development of CPP/CQAs to establish a process control strategy for the vector manufacturing platform.
- Contribute to the preparation of CMC sections for regulatory filings.
- 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.
- Remain at the forefront of the relevant science and competitive landscape including new process technologies.
- Perform other related duties and ad hoc projects as required.
Education & Qualifications
- Bachelor’s degree in a STEM discipline. An advanced degree, such as MS or PhD, is preferred.
- 7+ years of experience in the biotech industry, and experience in all stages of biological CMC development.
- Experience in viral vector process development and GMP manufacturing is required.
- Possesses an advanced technical understanding of downstream purification techniques utilized in viral vector manufacturing, including but not limited to, tangential flow filtration, column chromatography and sterile filtration, is required. Experience with fill/finish procedures is strongly preferred.
- Firsthand experience with AKTA-based chromatography systems and UF/DF skids is required.
- Proven experience in developing and scaling purification-based manufacturing processes for AAV viral vectors.
- Proven track record of successfully participating in the technology transfer of projects.
- Experience with JMP or other statistical analysis tools would be beneficial.
- Ability to efficiently interact with third parties and CDMOs to produce the highest quality drug products for patients.
- Strategic/forward-thinker with CMC technical experience.
- Experience interacting with regulatory agencies, specifically with the FDA and international regulatory authorities.
- Expertise with working on late phase, process performance qualification, and commercial programs is necessary.
- Familiarity with 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 the 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 exceptional 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 50% travel to vendor sites.
- Ability to work and support holidays, weekends and off hours, as needed.
Operations
Regulatory
Updated
February 2025
Location
Fulltime (5 days per week in office or plant), hybrid position with ability to travel between corporate office and CDMOs.
EEO
iECURE 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.
Director, Global Regulatory Affairs
Position Summary:
Reporting directly to the VP of Regulatory Affairs (RA), the Director of RA will be responsible for providing US and global regulatory leadership in support of the development, registration, and life-cycle management of our innovative gene therapy programs.
The responsibilities include providing US and global regulatory leadership and direction for gene therapy products, including developing long and short-term planning of regulatory projects that align with the company’s business plan, and developing strategies to ensure effective achievement of regulatory/business objectives. The individual will be responsible for staying current in the regulatory environment and assessing and communicating the impact of changes on business and product development.
The Director of RA will be an experienced and highly motivated professional who has developed regulatory strategy associated with all phases of drug development, including the coordination and preparation of document packages for regulatory submissions and leading cross functional teams. This individual will have a strong rapport and collaborative relationship with the US 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.
Specific Responsibilities
- Provides US and global regulatory leadership in support of the development, registration, and life-cycle management of products.
- Provides strategic regulatory direction including developing the global regulatory plan, advising on regulatory requirements for development plans, study designs and marketing approval, conducting risk assessments, and managing critical issues and health authority interactions.
- Writing regulatory documents (e.g. new INDs, briefing book content, RMAT/PRIME Designation request, Priority Review Requests, ODD, Pediatric Investigational Plans); reviewing core documents to support IND/CTA, in conjunction with VP of RA as needed.
- Foster positive relationships with FDA and other health authorities. Liaises and negotiates with health authorities as needed for all aspects pertaining to drug development including novel regulatory pathways for the company’s gene therapy products, resolution of key regulatory issues and to expedite approvals of products.
- Ensures the successful implementation and execution of regulatory plans.
- Harnesses knowledge of FDA and ICH regulatory requirements to strategically and operationally resolve regulatory issues impacting development programs to ensure business goals are met.
- Builds partnerships with key senior stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
- Takes a hands-on approach in leading the completion of IND/CTA and other global submission documents.
- Serves as a subject matter expert on relevant regulations, stays abreast of changes in the regulatory environment, and assesses impact of changes on business and product development programs.
- Proactively manages critical issues, taking leadership for regulatory contribution.
Education & Qualifications
- MS degree, advanced degree in a life science or related discipline preferred (e.g., PhD, PharmD, MSc, MBA).
- A minimum of 10 years of regulatory affairs experience, ideally gained from a mix of both large and small companies.
- 5+ years of regulatory filing (IND/CTA/BLA/MAA) strategy preferred.
- A prior track-record of successful regulatory delivery, with IND/CTA and NDA/BLA submission experience.
- Experience working with cell and gene therapies and/or rare diseases is preferred. Other therapeutic areas will be considered if the individual has experience defining and designing novel regulatory pathways.
- Extensive experience in interacting with global regulatory agencies (MHRA, TGA, EMA, Turkey, Canada, Japan).
- Ability to develop and implement global regulatory strategies.
- Practical understanding, interpretation, and application of relevant ICH and FDA guidelines and regulations.
- Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
- Ability to think creatively and develop creative solutions.
- Ability to prioritize and handle multiple projects simultaneously.
- Sense of urgency and perseverance to achieve bringing curative therapies to patients.
Department
Regulatory Affairs
Updated
March 2025
Location
Fulltime (5 days per week), Office-Based Position in Blue Bell, PA
EEO
iECURE 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.