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.
In this role, a typical day may include:
- 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.
To be considered, you should have:
- 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.
LOCATION:
Fulltime (5 days per week in office or plant), hybrid position with ability to travel between corporate office and CDMOs.