Senior Field Application Specialist Cell Therapy & Regulatory Markets - US based
U.S. Bankruptcy Court - District of CT, Boston, MA, United States
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 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
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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 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
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