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Research Associate Downstream Process Development Jobs in Massachusetts

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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 Massachusetts are hiring for Research Associate Downstream Process Development jobs?

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

Infographic showing various Research Associate Downstream Process Development job openings in Massachusetts as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 79% Full Time, 17% Part Time, and 2% Contract. Highlights an 86% Physical, 3% Hybrid, and 11% Remote job distribution.

DOWNSTREAM PROCESS DEVELOPMENT SCIENTIST

Billerica, MA • On-site

Full-time

Re-posted 17 days ago


Job description

Company Description

MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.

Job Description
  • Design fit-for-purpose purification experiments according to the stage of development
  • Ensure scientific evaluation of impact of deviations to Downstream validation studies
  • Compile and analyze experimental data to generate process knowledge and decide on next steps
  • Write development and validation reports and ensure their timely delivery
  • Prepare and present project updates to global project team and to upper management
  • Ensure a continuous improvement within Downstream process development activities
  • Represent & promote E2E and Biodevelopment activities (presentations, congresses, events)
  • Technical lead on the overall projects (supervises Downstream processes development and implementation of new methods and services)
  • Technical leader for equipment, technologies for Downstream process development
  • Responsible for activities ranging from protein purification, filtration, biochemical and biophysical characterization of proteins: -
  • Execute routine protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA systems (Unicorn software)
  • Perform analyses including but not limited to SDS-PAGE, SE-HPLC, LAL, host cell-DNA, host cell protein, as necessary
  • To develop, validate and transfer robust analytical methods required for successful drug development and manufacturing.
  • To support follow-up and troubleshooting on analytical methods.
  • Provide expertise and insight to guide development of appropriate purification methods
  • Develop novel purification processes as well as using standard methods to purify proteins from the mg to gram scale. Processes will be multiple steps and must provide necessary clearance of viruses, endotoxin, and host cell proteins and DNA.
  • Perform, develop and optimize robust, efficient, scalable strategies for improving process performance. Activities will include small-scale studies and pilot scale purification studies.
  • Apply DOE methods to purification activities
Qualifications
  • Engineering/Master degree (PhD preferred) in biotechnology with 5+ years in the biopharmaceutical industry
  • Solid and proven theoretical basis and hands-on experience in protein purification and analytical characterization
  • Hands-on experience with purification unit operations including filtration, chromatography, TFF, UF/DF, AKTA, UNICORN and HPLC systems.
  • Strong hands-on experience in troubleshooting and routine instrument maintenance.
  • Experienced in protein purification via affinity, hydrophobic interaction (HIC), ion exchange (IEX), size exclusion (SEC) and mixed-mode chromatography
  • Knowledge and skills in biochemical characterization of proteins including analytical and biophysical
  • Proven track record in Purification Process Development is necessary with emphasis on chromatographic separations and excellent understanding of and experience with chromatographic resin screening and process optimization.  Experience with scale-up and GMP manufacturing is desirable.
  • Solid and proven working knowledge of DOE. Ability to critically analyze data using statistical tools and to compile technical reports
  • Excellent presentation and communication skills
  • Results-oriented with ability to work and deliver under pressure
  • Excellent English (written, oral) 
Additional Information

All your information will be kept confidential according to EEO guidelines.