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Research Associate Downstream Process Development Jobs in Frederick, MD

Emmes

Sr. Clinical Research Associate

Rockville, MD · On-site +1

Overview Sr. Clinical Research Associate US remotely and on-site (80% travel) Be Part of One Team ... May assist with the development and/or review of study related materials including protocols ...

MSD

Senior Research Associate

Gaithersburg, MD · On-site

$67K - $101K/yr

This is a laboratory-based position responsible for advancing research and/or development ... processing/aliquotting/vialing/labeling materials, and preparing and maintaining reagent ...

MSD

Senior Research Associate

Gaithersburg, MD · On-site

$67K - $101K/yr

This is a laboratory-based position responsible for advancing research and/or development ... processing/aliquotting/vialing/labeling materials, and preparing and maintaining reagent ...

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Research Associate Downstream Process Development information

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$18

$33

$49

How much do research associate downstream process development jobs pay per hour?

As of Sep 10, 2026, the average hourly pay for research associate downstream process development in Frederick, MD is $33.49, according to ZipRecruiter salary data. Most workers in this role earn between $27.50 and $41.11 per hour, depending on experience, location, and employer.

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 near Frederick, MD are hiring for Research Associate Downstream Process Development jobs?

Cities near Frederick, MD 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 Frederick, MD as of September 2026, with employment types broken down into 62% Full Time, and 38% Part Time. Highlights an 100% In-person job distribution, with an average salary of $69,659 per year, or $33.5 per hour.

Principle Process Engineer, Viral Vector Process Characterization and Commercialization

Gaithersburg, MD • On-site

AstraZeneca
Pharmaceutical Product Wholesalers • 10K+ employees
Learn more about AstraZenecaexternal

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 7 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

23rd of 86 rated pharmaceutical

Job description

About AstraZeneca in Gaithersburg, MD
Our Gaithersburg, Maryland campus is a global center for innovation in biologics, cell therapy, and vaccines. The site fosters a highly collaborative and cross-functional culture that enables teams to deliver life-changing medicines across AstraZeneca's pipeline. With state-of-the-art research, development, and manufacturing capabilities, we advance scientific excellence through collaboration, diversity, and innovation.
Job Description
AstraZeneca is seeking an experienced Principal Process Engineer to support late-phase process development, process characterization, validation, and commercialization of viral vector manufacturing processes. This individual contributor role will provide hands-on technical leadership across internal and external manufacturing sites, with a strong focus on PPQ readiness, BLA and other global marketing applications, and post-approval lifecycle management.
The successful candidate will have direct late-stage development and commercialization experience and demonstrated ability to independently author high-quality CMC content for regulatory submissions. The role will partner with Drug Substance, Drug Product, Analytical Sciences, Quality, Regulatory Affairs, Manufacturing Operations, and external CMOs or CDMOs to ensure that process knowledge, validation strategy, control strategy, and filing content are scientifically sound, consistent, and inspection ready.
Key Responsibilities
Late-Phase Process Development and Validation
  • Lead or support the design, execution, analysis, and documentation of process characterization and validation studies for viral vector manufacturing processes.

  • Provide technical support for upstream, downstream, formulation, fill-finish, and related manufacturing operations.

  • Develop and maintain science- and risk-based approaches for process parameter classification, proven acceptable ranges, in-process controls, and control strategy development.

  • Support PPQ planning, protocol development, manufacturing execution, deviation assessment, data review, and final report authoring.

  • Apply process knowledge and data analysis to identify technical risks, investigate process performance issues, and recommend practical solutions.

Regulatory CMC Authoring and Marketing Applications
  • Independently author and coordinate CMC sections for BLAs, MAAs, and other global marketing applications, with emphasis on viral vector drug substance and drug product manufacturing, process controls, process validation, and supporting lifecycle documentation.

  • Author and review relevant CTD Module 3 content, including manufacturing process descriptions, control of critical steps and intermediates, process validation or evaluation, process development summaries, control strategy content, comparability assessments, and supporting technical justifications.

  • Translate complex process development, characterization, validation, and manufacturing data into clear, accurate, and regulator-ready narratives, tables, and responses.

  • Ensure consistency of process descriptions, terminology, acceptance criteria, and technical conclusions across submission sections and source documents.

  • Lead or support responses to Health Authority questions and information requests related to manufacturing process, process performance, validation, comparability, and control strategy.

  • Support post-approval changes, comparability assessments, supplements or variations, and commercial lifecycle management submissions.

Commercialization and Manufacturing Support
  • Partner with internal manufacturing sites and external CMOs or CDMOs to support technology transfer, engineering activities, PPQ execution, commercial readiness, and continued process verification.

  • Review manufacturing records, process data, deviations, change controls, investigations, and technical reports to assess product and process impact.

  • Provide technical input to risk assessments, FMEAs, validation plans, protocols, reports, and integrated control strategy documents.

  • Contribute to inspection readiness and support technical preparation for regulatory inspections and partner audits.

Cross-Functional Collaboration
  • Collaborate with Analytical Sciences, Quality, Regulatory Affairs, Manufacturing Operations, Supply, and other technical functions to align development, validation, and filing strategies.

  • Represent viral vector process engineering in cross-functional project teams, governance forums, technical reviews, and risk discussions.

  • Communicate technical risks, recommendations, decisions, and progress clearly to project teams and senior stakeholders.

  • Mentor less experienced scientists and engineers and promote strong technical documentation practices, without direct people-management responsibility.

Required Qualifications
  • BS degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or a related scientific or engineering discipline with a minimum of 14 years of relevant experience in biopharmaceutical process development, manufacturing, validation, or commercialization; Master's degree in a relevant discipline with a minimum of 10 years of experience: PhD with a minimum of 7 years of experience.

  • Demonstrated late-stage development and commercialization experience, including process characterization, PPQ, validation, and commercial readiness.

  • Demonstrated experience independently authoring CMC sections for a BLA, MAA, or comparable marketing application. Experience authoring multiple regulatory sections and responding to Health Authority questions is required.

  • Strong understanding of Biologics manufacturing platforms, including upstream production, downstream purification, formulation, and fill-finish operations.

  • Working knowledge of GMP manufacturing, process validation principles, risk management, comparability, control strategy, and lifecycle management.

  • Ability to interpret complex technical data and convert it into concise, consistent, and regulator-ready documentation.

  • Excellent written and verbal communication skills, with demonstrated ability to work effectively across functions, sites, and external partners.

Preferred Qualifications
  • Direct experience with viral vector manufacturing and commercialization.

  • Significant authorship responsibility for an approved or filed BLA, MAA, or other global marketing application.

  • Experience supporting Health Authority interactions, regulatory responses, pre-approval inspections, or commercialization readiness assessments.

  • Experience working with CMOs or CDMOs and supporting multi-site technology transfer and PPQ programs.

  • Familiarity with analytical method integration, raw material and cell bank control strategies, continued process verification, and post-approval change management.

  • Demonstrated ability to influence cross-functional teams and deliver complex technical work with limited supervision.

Why AstraZeneca
At AstraZeneca, you will have the opportunity to make a meaningful impact through science that changes lives. Join a diverse and inclusive environment where innovation thrives, collaboration is valued, and every employee contributes to our mission to deliver life-changing medicines.
The annual base pay (or hourly rate of compensation) for this position ranges from $122,312.80 - $183,469.20 . Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
03-Sep-2026
Closing Date
24-Sep-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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About AstraZeneca

Sourced by ZipRecruiter

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. A place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team. Make a meaningful impact that brings real benefits to society. By applying your knowledge of data, you will help to redefine our industry and ultimately save lives. Work with experts who share a common goal: to accelerate the potential of medicines and the science of tomorrow.

Industry

Pharmaceutical product wholesalers and pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Cambridge, Cambridgeshire, GB

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