Application Scientist - Downstream Processing and Pharma Analytics

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

Experience Level

Mid Level