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Application Scientist – Pharma Analytics / Purification (Downstream Processing)

Thermo Fisher Scientific -
Remote

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Job details

Full-time
13 days ago

Qualifications

Doctoral degree
Chemical Engineering
B.Sc
Laboratory experience
Master's degree
Analysis skills
Presentation skills
Bachelor's degree
M.Sc
Communication skills
Analytics

Full job description

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

Apply Now

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