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Research Associate Downstream Process Development Jobs in Pennsylvania

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In Vivo Research Associate

Hummelstown, PA · On-site

... drug development and research under general supervision. This role ensures the proper care and ... Conduct downstream analyses of ex vivo samples to support study objectives. * Assist in the ...

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Research Associate Downstream Process Development information

What is a research associate downstream process development?

A Research Associate in Downstream Process Development works within biotechnology or pharmaceutical companies to optimize and scale up the purification and recovery of biological products, such as proteins or antibodies, after initial production. They focus on processes like filtration, chromatography, and centrifugation to ensure product quality and yield. These professionals design experiments, analyze data, and support the transfer of processes from laboratory scale to manufacturing. Their work is crucial for developing efficient, reproducible, and regulatory-compliant methods for producing biopharmaceuticals.

What are the key skills and qualifications needed to thrive as a research associate in downstream process development?

To thrive as a Research Associate in Downstream Process Development, you need a solid background in biochemistry, molecular biology, or chemical engineering, often demonstrated by a bachelor's or master's degree in a related field. Familiarity with chromatography systems (such as AKTA), filtration technologies, and Good Manufacturing Practice (GMP) standards, along with data analysis software, is typically required. Strong problem-solving skills, attention to detail, and effective teamwork and communication abilities help individuals excel in this role. These competencies are crucial for ensuring efficient, scalable purification processes and maintaining product quality in biopharmaceutical development.

What are the typical challenges faced by a research associate in downstream process development, and how can they be addressed?

A Research Associate in Downstream Process Development often encounters challenges such as optimizing purification processes for new biologics, troubleshooting equipment issues, and ensuring scalability from laboratory to production scale. Effective communication with cross-functional teams, such as upstream scientists and analytical specialists, is essential to resolve issues quickly. Staying current with new purification technologies and maintaining meticulous documentation can also help address these challenges and support successful process development.

What is the difference between Research Associate Downstream Process Development vs Research Associate Upstream Process Development?

AspectResearch Associate Downstream Process DevelopmentResearch Associate Upstream Process Development
Primary FocusPurification, filtration, chromatography of bioproductsCell culture, media optimization, bioreactor operation
Skills & CertificationsProtein purification, chromatography techniques, GMP complianceCell culture, aseptic techniques, bioreactor handling
Work EnvironmentLaboratory, manufacturing, quality controlLaboratory, bioprocessing facilities
Industry UsageBiopharmaceutical manufacturing, biotech researchBiopharmaceutical development, biotech research

While both roles support bioprocess development, Research Associate Downstream Process Development focuses on purification and filtration of bioproducts, whereas Research Associate Upstream Process Development emphasizes cell culture and bioreactor processes. Understanding these differences helps candidates align their skills with the appropriate role in biopharmaceutical production.

What cities in Pennsylvania are hiring for Research Associate Downstream Process Development jobs?

Cities in Pennsylvania with the most Research Associate Downstream Process Development job openings:

Research Associate Downstream Process Development jobs near you
Infographic showing various Research Associate Downstream Process Development job openings in Pennsylvania as of August 2026, with employment types broken down into 88% Full Time, and 12% Contract. Highlights an 97% In-person, and 3% Remote job distribution.

(Associate) Director, Viral Downstream Process Development

Philadelphia, PA

Dispatch Bio
See more jobs at Dispatch Bioexternal

Full-time

Re-posted 29 days ago

Job description

The role:

The (Associate) Director will serve as the downstream processing expert working closely with CDMOs to generate lentivirus and adenovirus products.  Reporting into the Vice President of Process Development, this individual will also be responsible for building out the internal downstream purification capabilities within process development to support scale up and scale down.

Key responsibilities:

  • Oversee planning and execution of tech transfers, development and scale up of viral products being manufactured at CDMOs
  • Serve as the downstream subject matter expert on both internal and external (CDMO, equipment suppliers, etc.) teams
  • Build out internal downstream capabilities by identifying/procuring scale down models for process development
  • Design and execute studies to identify critical process parameters and optimize process setpoints across the clarification, Tangential Flow Filtration (TFF), chromatography and sterile filtration steps
  • Responsibility for execution, data review, analysis, and maintaining accurate and detailed lab notebooks
  • Author and review technical documents, including but not limited batch records, SOPs and development reports and process-specific sections of regulatory documents.
  • Represent the company externally at meetings (professional associations, with regulatory bodies, etc.)
  • Work cross-functionally with analytical development, research and development, program management to advance clinical programs

Required experience & skills: 

  • MS or Ph.D. in Chemical Engineering, Bioengineering or related discipline
  • Minimum of 10 years of experience with downstream purification process development in the biopharma industry
  • Experience directly managing a team
  • Technical experience with downstream unit operations including clarification, TFF, chromatography, sterile filtration and formulation
  • Experience with scale up and scale down of purification processes
  • An understanding of cGMP and regulatory requirements for biopharmaceuticals
  • Strong organizational & problem-solving skills, with the proven ability to collaborate in a dynamic team environment
  • Strong scientific reasoning, problem-solving, and applied statistics skills, including the ability to break down complex problems into manageable hypotheses
  • Proficiency in using Microsoft Word, Excel, Power Point and data analysis/presentation software such as JMP and/or GraphPad
  • Excellent interpersonal, verbal and written communication skills.
  • Excellent organizational and planning skills, strong work ethic and the desire to work in a flexible and fast-paced, entrepreneurial environment

Preferred experience & skills: 

  • Experience with Quality by Design (QbD) approach to drug development including risk assessments, Design of Experiments (DoE) and statistical methods
  • Experience drafting CMC sections for INDs
  • Experience with technology transfers to external manufacturing facilities

 

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