| Job Description: |
Process Development, Experimental Design & Optimization
- Lead the design, optimization, and scale-up of automated, closed-system processes for dendritic cell, CAR
T, autologous T cells, and stem cell-based products.
- Evaluate and integrate novel technologies (e.g., automated selection and transduction systems, closed
culture platforms) to enhance robustness, reproducibility, and compliance with GMP standards.
- Develop and optimize RNA synthesis workflows, including IVT, purification, and capping strategies, to
support preclinical and clinical supply.
- Collaborate with formulation scientists to establish scalable, reproducible LNP formulation processes
tailored for diverse therapeutic payloads.
- Define and monitor critical process parameters (CPPs) and critical quality attributes (CQAs) to ensure
consistent product quality and regulatory readiness.
- Partner with the manufacturing team for operator training and investigations.
- Author process development and qualification protocols and manufacturing batch record in accordance
with phase-appropriate GMP standards. Facilitates effective dialogue across manufacturing, quality, and
clinical teams, ensuring process development priorities are understood and integrated into program
timelines
- Provides scientific and strategic leadership for the analytical function, mentoring junior scientists and
fostering a culture of rigor, accountability, and innovation
- Collaborate with equipment vendors, CDMOs, and technology providers to evaluate platforms, execute
tech transfers and manage deliverables.
Research Compliance, GMP Alignment & Documentation
- Administer biological research activities in accordance with approved protocols, bio-safety requirements,
and institutional policies.
- Author and maintain process development documentation, qualification protocols, standard operating
procedures (SOPs), and manufacturing batch records as applicable.
- Support alignment with phase-appropriate GMP expectations and regulatory readiness for translational
research activities.
Laboratory Operations & Personnel Supervision
- Manage daily laboratory operations, including the cultivation and study of live specimens, equipment use,
and resource coordination.
- Train, and direct the work of research staff, postdoctoral fellows, graduate students, and
technical personnel.
- Support operator training, deviation investigations, and continuous improvement initiatives in collaboration with manufacturing and research teams.
Collaboration, Technology Evaluation & External Partnerships
- Collaborate with equipment vendors, CDMOs, and technology providers to evaluate platforms, execute
tech transfers and manage deliverables.
- Collaborate with interdisciplinary teams to analyze scientific and operational challenges and recommend
solutions.
- Support technology transfer activities and manage deliverables with external collaborators.
Scientific Communication & Research Support
- Maintain accurate laboratory records and analyze research data in accordance with institutional and
funding requirements.
- Prepare reports, presentations, and documentation to communicate research results to internal and
external stakeholders.
- Contribute to grant applications, manuscripts, and other research advancement activities as assigned.
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| Preferred: |
- Hands-on expertise with closed-system cell processing platforms (e.g., CliniMACS Prodigy, DynaSelect, or equivalent) and associated unit operations.
- Experience in RNA manufacturing (IVT, purification) and LNP formulation techniques.
- Demonstrated track record of leading process development from research to GMP readiness.
- Strong understanding of GMP principles, regulatory expectations (FDA/EMA/ICH), and quality systems.
- Excellent leadership, project management, and communication skills with a proven ability to collaborate across disciplines.
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