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Downstream Process Development Jobs in Washington

GAP SOLUTIONS INC

Biologist (50849)

Gaithersburg, MD

Develop downstream (purification) processes, under the supervision of a project lead scientist, for ... Coordinate with project management to ensure development milestones and study deliverables are met ...

Valspec

CQV Consultant

Rockville, MD · On-site

Downstream Processing * CIP (Clean-in-Place) Systems * PSE (Process Support Equipment) * Clean ... Join a team where your contributions matter, your development is prioritized, and your success is ...

Unisys

Product Analyst / Business Process Analyst

Reston, VA

$63.50K - $85.30K/yr

Depth Capture edge cases, data conditions, dependencies, and downstream impacts. * Process Mapping ... Test Case Development Write detailed test cases and acceptance criteria based on requirements.

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How much do downstream process development jobs pay per hour?

As of May 30, 2026, the average hourly pay for downstream process development in Washington is $38.15, according to ZipRecruiter salary data. Most workers in this role earn between $31.30 and $46.83 per hour, depending on experience, location, and employer.

What is a Downstream Process Development job?

A Downstream Process Development job involves optimizing and scaling purification processes for biologics, such as proteins, antibodies, or gene therapies. Scientists and engineers in this role develop efficient methods for isolation, purification, and formulation of therapeutic products while ensuring quality and regulatory compliance. Key activities include chromatography, filtration, and process analytics to improve yield, purity, and consistency. This role is critical in biotech and pharmaceutical industries to ensure safe and effective drug production for clinical and commercial use.

What are the key skills and qualifications needed to thrive in the Downstream Process Development position, and why are they important?

To excel in Downstream Process Development, you generally need a strong background in biochemistry, chemical engineering, or a related life sciences field, often with experience in bioprocessing or purification technologies. Familiarity with chromatography systems, filtration equipment, process analytical technology (PAT), and relevant software such as DeltaV or Unicorn is frequently required, along with knowledge of GMP and regulatory standards. Excellent problem-solving, project management, and cross-functional communication skills help professionals succeed in dynamic team environments. These competencies are crucial for developing efficient, scalable purification processes that ensure high product quality and support organizational goals.

What are typical daily responsibilities for someone in Downstream Process Development?

Professionals in Downstream Process Development are typically responsible for designing, optimizing, and scaling up purification processes for biopharmaceutical products. Their day-to-day work may involve conducting laboratory experiments, analyzing data, troubleshooting technical issues, and documenting process changes in accordance with regulatory standards. They also frequently collaborate with upstream processing, analytical, and quality teams to ensure seamless transfer and integration of processes. The role often includes participating in project meetings, contributing to process validation efforts, and supporting technology transfer to manufacturing teams, making it both technically challenging and collaborative.
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Downstream Process Development jobs near you
Senior Scientist, Viral Vector Process Development, Downstream

Senior Scientist, Viral Vector Process Development, Downstream

AstraZeneca

Gaithersburg, MD • On-site

$98.90K - $135.10K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

This job post has expired today. Applications are no longer accepted.

AstraZeneca rating

8.6

Company rating: 8.6 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

16th of 70 rated pharmaceutical

Job description

AstraZeneca is looking for a highly motivated and experienced Senior Scientist, Viral Vector Process Development (Downstream). The candidate will play a critical role in building and leading a high-performing team that accelerates AstraZeneca's emerging Cell Therapy modalities portfolio. You will design, execute, and optimize scalable Lentiviral Vector (LVV) downstream purification processes with a primary focus on clinical and commercial scales. You will contribute hands-on to experimental design, process characterization, and scale-up/tech transfer activities from research through INDenabling, partnering closely with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs. This position is based in Gaithersburg, MD.
Key Responsibilities
  • Downstream Process Development: Plan and perform experiments to develop scalable, cost-effective LVV purification processes for ex vivo and in vivo applications, targeting yield, purity, potency, and consistency.

  • Unit Operations Execution: Execute and optimize clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation/fill-related steps; define phase-appropriate in-process controls and operating ranges.

  • Process Characterization & Data Analysis: Design and analyze studies (including DOE) to identify CPPs/CMAs, establish design space, and justify control strategies; trend performance, conduct troubleshooting and root cause analysis, and recommend corrective actions.

  • Scale-Up, Scale-Down & Tech Transfer Support: Develop representative scale-down models; support scale-up to pilot, clinical, and commercial-relevant equipment; prepare technical transfer documents and assist transfers to internal GMP sites and CDMOs.

  • Novel Technologies & Continuous Improvement: Evaluate and implement next-generation purification technologies and consumables to improve efficiency, robustness, and product quality; contribute to continuous improvement initiatives.

  • Documentation & Compliance: Author high-quality protocols, reports, batch records, and development summaries; support drafting of CMC content for regulatory submissions (e.g., IND) and align practices with cGMP and Quality systems expectations.

  • Cross-Functional Collaboration: Partner with upstream PD and Analytical Development to link process parameters with product quality attributes (e.g., titer, infectivity/potency, residuals/impurities); collaborate with Manufacturing and Quality on operational feasibility and compliance.

Qualifications
  • Education: Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands-on industry experience.

  • Experience: Hands-on downstream process development for LVV (preferred) or other viral vectors/biologics; familiarity with clinical/commercial scale considerations and tech transfer.

  • Technical Expertise: Practical proficiency in clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation; understanding of viral vector-specific impurity profiles (host cell proteins/DNA, process residuals) and strategies to control them.

  • Data & Risk Tools: Working knowledge of statistical analysis and DOE; familiarity with QbD principles, risk assessments (e.g., FMEA), and process justification.

  • GMP & Regulatory: Understanding of cGMP and Quality systems; familiarity with FDA/EMA guidance relevant to gene and cell therapy; experience contributing to CMC sections of regulatory filings is a plus.

  • Communication & Collaboration: Strong written and verbal communication; ability to work effectively in cross-functional, matrixed teams; demonstrated problem-solving and troubleshooting skills.

Preferred Qualifications
  • Experience scaling LVV or other viral vector/biologic purification processes from preclinical to clinical/commercial-relevant equipment and consumables.

  • Experience supporting tech transfer and implementation at internal sites and CDMOs.

  • Exposure to PAT/digital tools for process monitoring and data integrity; experience with knowledge management systems.

  • Demonstrated innovation in evaluating/implementing next-generation purification technologies.

At AstraZeneca, we are at the forefront of innovation with constant new products and launches. Our dynamic environment encourages collaboration and problem-solving as we strive to deliver life-changing medicines. We embrace challenges in rapidly changing markets by continuously seeking better ways to deliver medicines to patients. Our team is diverse and connected globally, working together to push the boundaries of supply chain excellence. With a focus on sustainability and a commitment to doing things the right way, we offer opportunities for growth and development in a supportive environment.
Join us in making a difference-apply today!
The annual base pay for this position ranges from $108,473.60 - $162,710.40. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
20-May-2026
Closing Date
28-May-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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