Description
The Senior Field Application Specialist - Cell Therapy & Regulatory Markets serves as a strategic scientific partner to leaders in the cell therapy, biopharmaceutical, and regulated research sectors (including CMOs and CDMOs). This is a high-impact, consultative role designed to empower customers as they navigate the critical transition from discovery to clinical manufacturing.
Leveraging deep expertise in CAR-T workflows and GMP/GxP requirements, the Sr. FAS provides the technical bridge between high-performance CST products and the rigorous demands of a regulated environment. You will act as a trusted advisor on assay validation, quality standards, and regulatory documentation, ensuring our customers achieve successful implementation in both research and clinical manufacturing. Beyond technical support, you will be a key driver of commercial success, partnering with sales teams to identify high-value opportunities, influence product strategy, and exceed regional budgetary goals.
Regulatory & Technical Consultative Support Strategic Liaison:
- Serve as the primary scientific and technical authority for customers across the region, specifically those operating in CAR-T, cell therapy development, and GMP/GxP environments
- Compliance Expert: Act as the Subject Matter Expert (SME) for customers in regulated spaces; advise on CST product selection meeting GMP, ISO 13485, and quality standards, including assay validation, comparability studies, and documentation
- End-to-End Workflow Support: Provide expert pre- and post-sales technical guidance across the entire continuum-from discovery and translational research to clinical manufacturing and Quality Control (QC)
- Regulatory Inquiry Management: Resolve complex customer inquiries regarding traceability, reproducibility, lot-to-lot consistency, and change control protocols
- Risk Mitigation: Support technology transfer teams and clinical development groups to ensure seamless integration of CST reagents into validated workflows
Commercial Strategy & Market Growth Business Partnership:
- Partner with the regional commercial team to identify and qualify high-value opportunities within the Cell and Gene Therapy (CGT) sector
- Value Propositin: Deliver high-impact technical presentations and "sales launch packages" that address the specific pain points of researchers in regulatory markets
- Revenue Accountability: Drive successful product adoption across the region to meet or exceed territory budgetary goals and revenue forecasts. KOL & Network Building: Cultivate a high-level
- KOL network across the region identify and facilitate joint collaborations between key customers and CST R&D
- Market Intelligence: Represent CST at premier scientific conferences and industry meetings (Immuno-oncology, Biomanufacturing) to maintain a pulse on regulatory shifts and competitor landscapes
Internal Leadership & Global Collaboration Product Strategy Influence:
- Collaborate with Global Marketing, Product Management, and R&D to align customer needs with CST's product roadmap, influencing the development of next-generation reagents for the clinical market
- Regional Mentorship: Foster a collaborative regional FAS culture; act as a technical escalation point and provide "people cover"/mentorship for the broader FAS team as needed
- Training & Enablement: Work with the Global Product Trainer to design and deliver specialized workshops for sales representatives and distribution partners
- Early Access Program (EAP): Lead the technical execution of Early Access Programs in the region, bridging the gap between R&D and field-testing
Requirements
- PhD or Master's in Cell Biology, Immunology, or equivalent
- 8+ years of experience working directly in or supporting GMP/GxP environments within the biopharmaceutical industry
- Hands-on experience in GMP/ GxP environments, including assay development, validation, or manufacturing support
- Deep technical knowledge of CAR-T cell manufacturing processes
- Strong understanding of regulatory expectations in clinical development
- Proven ability to communicate complex scientific concepts to diverse audiences, including scientists, QA/QC, and regulatory stakeholders
- Experience in an international business environment
- Ability to work in a fast-paced environment, manage deliverables and deadlines simultaneously
- Excellent communication, presentation and organizational skills
- Ability to adapt scientific communication in the field based on customer needs
- Excellent knowledge of English both in word and writing
- Travel frequently in the field to customers (>60%)
Ideally, you have...
- Prior sales experience and commercial mindset with demonstrated business acumen
- Experience with confocal and fluorescent microscopy
- Experience analyzing and responding to regional sales and revenue trends
- Ability to proactively manage multiple priorities and deadlines across time zones
