Application Scientist - Pharma Analytics / Purification (Downstream Processing)Thermo Fisher • United States
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Application Scientist - Pharma Analytics / Purification (Downstream Processing)
Thermo Fisher
- United States
- United States
Über
Role Overview We're not just looking for a lab executor here—this role sits at the intersection of process development, analytics, and scale-up. As an Application Scientist – DSP, you will lead the design, development, and optimization of downstream purification processes for biologics in a single-use bioprocessing environment. You'll play a key role in enabling robust, scalable, and compliant purification workflows while collaborating across upstream, analytics, quality, and manufacturing teams. Key Responsibilities Downstream Process Development & Optimization Design and optimize purification processes including: Chromatography (affinity, ion exchange, etc.) Filtration (TFF, depth filtration) Viral clearance strategies Perform lab-scale studies to evaluate process parameters for yield, purity, and robustness Implement and optimize single-use technologies in DSP workflows Integrate downstream processes with upstream and analytical workflows Pharma Analytics & Characterization Execute and support analytical workflows including: qPCR (minimum 3–4 years hands-on) Sanger Sequencing Support impurity profiling and adventitious agent testing strategies Interpret analytical data to guide purification and process decisions Collaborate with analytical teams for method development and validation Technology Transfer & Scale-Up Lead transfer of DSP processes from lab to pilot and commercial scale Develop and review: SOPs Batch records Technology transfer documents Troubleshoot scale-up challenges in single-use manufacturing environments Work closely with engineering and manufacturing teams Data Analysis & Documentation Analyze experimental data for process performance and optimization opportunities Ensure compliance with Good Documentation Practices (GDP) Prepare: Technical reports Protocols Client/stakeholder presentations Cross-Functional Collaboration Partner with: Upstream Processing Analytical Development Quality & Regulatory Provide technical expertise in DSP during: Project reviews Troubleshooting discussions Act as a subject matter expert (SME) for purification and analytics Continuous Improvement & Innovation Track advancements in: Downstream processing technologies Single-use systems Process Analytical Technology (PAT) Drive improvements in process efficiency, scalability, and cost-effectiveness Contribute to innovation initiatives within BDC Qualifications Education Ph.D. / M.S. / B.S./Post Graduation in: Chemical Engineering Biotechnology Biochemistry Or related field Experience 8+ years in downstream process development in biopharma Strong expertise in: Chromatography TFF / filtration Viral clearance Hands-on lab experience with DSP equipment 3–4+ years hands-on experience in: qPCR Sanger Sequencing Experience in: Impurity testing Adventitious agent testing Exposure to: Pharma analytics Regulated environments (cGMP) Customer-facing or application roles (preferred) Skills & Competencies Strong process development and troubleshooting capability Data-driven mindset with solid analytical skills Effective communication and presentation skills Ability to manage multiple projects and timelines Collaborative, team-oriented approach Preferred / Desired Attributes Familiarity with: cGMP, ICH guidelines Regulatory expectations for biologics Knowledge of: PAT (Process Analytical Technology) Automation in DSP
Sprachkenntnisse
- English
Hinweis für Nutzer
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