Application Scientist – Pharma Analytics / Purification (Downstream Processing)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description 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 1. 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 2. 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 3. 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 4. 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 5. 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 6. 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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.