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Application Scientist - Pharma Analytics / Purification (Downstream Processing)Thermo Fisher Scientific • United States
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Application Scientist - Pharma Analytics / Purification (Downstream Processing)

Thermo Fisher Scientific
  • US
    United States
  • US
    United States
Jetzt Bewerben

Über

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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
  • United States

Sprachkenntnisse

  • English
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