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Upstream Process Development Jobs in California (NOW HIRING)

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Upstream Process Development information

What are the key skills and qualifications needed to thrive in upstream process development?

Success in Upstream Process Development requires a strong background in biology, biochemistry, or chemical engineering, often with an advanced degree and experience in cell culture or fermentation techniques. Familiarity with bioreactors, process control systems, and analytical instrumentation, as well as knowledge of cGMP regulations, is essential. Critical thinking, problem-solving, and effective communication are important soft skills for optimizing processes and collaborating across multidisciplinary teams. These competencies ensure efficient development of scalable production processes, maintaining product quality and regulatory compliance.

What are some common challenges faced in upstream process development and how do teams typically address them?

One of the main challenges in upstream process development is optimizing cell culture conditions to consistently achieve high yields and product quality. Teams often encounter variability in biological systems and must troubleshoot issues such as contamination, scale-up inconsistencies, or nutrient limitations. Collaboration with analytical, downstream, and quality teams is essential to identify root causes and implement solutions. Regular data review meetings, cross-functional problem-solving, and continuous process improvement are standard practices to ensure robust upstream processes.

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

AspectUpstream Process DevelopmentDownstream Process Development
FocusDevelopment of cell culture, fermentation, and bioreactor processesPurification, filtration, and formulation of bioproducts
Skills & CredentialsBioprocess engineering, molecular biology, biochemistryBioprocessing, chromatography, analytical chemistry
Work EnvironmentLaboratories, bioreactors, pilot plantsPurification facilities, labs, quality control
Industry UsageBiotech, pharmaceutical manufacturingBiotech, pharmaceutical manufacturing

Upstream Process Development focuses on creating and optimizing cell culture and fermentation processes to produce bioproducts. In contrast, Downstream Process Development involves purifying and finishing these products. Both roles are essential in biopharmaceutical manufacturing and require similar scientific backgrounds, but they specialize in different stages of bioprocessing.

What are common upstream process development jobs?

Common upstream process development jobs include roles such as upstream process scientist, process engineer, and bioprocess development specialist. These positions focus on optimizing cell culture, fermentation, and bioreactor processes to improve product yield and quality, often requiring knowledge of bioreactor operation, cell biology, and process scale-up. Skills in laboratory techniques, process modeling, and regulatory compliance are also important in these roles.

What is an upstream process development job?

An upstream process development job involves designing, optimizing, and scaling the early stages of biopharmaceutical production, such as cell culture and fermentation processes. Professionals in this role typically work with bioreactors, laboratory equipment, and process analytical tools to improve yield and quality of biological products. Strong knowledge of microbiology, biochemistry, and process engineering is essential, along with adherence to regulatory standards.

What are popular job titles related to Upstream Process Development jobs in California?

For Upstream Process Development jobs in California, the most frequently searched job titles are:

What job categories do people searching Upstream Process Development jobs in California look for?

The top searched job categories for Upstream Process Development jobs in California are:

What cities in California are hiring for Upstream Process Development jobs?

Cities in California with the most Upstream Process Development job openings:

Upstream Process Development jobs near you
Infographic showing various Upstream Process Development job openings in California as of September 2026, with employment types broken down into 85% Full Time, and 15% Contract. Highlights an 90% In-person, and 10% Hybrid job distribution.

Principal Scientist, Late Stage Upstream Process Development

San Francisco, CA • On-site

CEDENT
IT Services • 11 - 50 employees
Learn more about CEDENTexternal

Full-time

Re-posted 18 days ago

Job description

Client is seeking an experienced and driven scientist/engineer to lead late-stage upstream cell culture process development activities for clinical and commercial-stage large molecule programs. This individual will serve as the upstream lead for scale-up and tech transfer to manufacturing sites, establishing process validation (PV) strategy and PPQ/post-approval process support.
Key Accountabilities/ Core Job Responsibilities
  • Lead scale-up and tech transfer of the upstream process to manufacturing sites, ensuring alignment with control strategy and regulatory filings.
  • Serve as the technical lead, responsible for upstream process activities for a late-stage large molecule programs including commercial manufacturing support
  • Author and review relevant CMC documentation including PV protocols/reports and regulatory sections (e.g., BLA, IND amendments).
  • Develop and execute strategies for process performance qualification (PPQ) and continued process verification (CPV).
  • Collaborate cross-functionally with MSAT, Downstream, Analytical Development, CMC management, Manufacturing Operations, QA, QC, Regulatory, and Contract Manufacturers
  • Represent upstream function in regulatory strategy, technical meetings, and CDMO interactions.
  • Provide technical support for upstream process-related investigations, product impact assessments, change control assessments, CAPA assessments etc.
Qualifications/Skills
  • PhD in biology, biochemistry, chemical engineering or related scientific discipline with minimum 7 years of cell culture process development experience in the biotech/biopharma industry; or BS/MS with 12+ years of experience.
  • In-depth understanding of CHO-based fed-batch processes, scale-up/scale-down principles, and statistical tools.
  • Thorough understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities
  • Demonstrated experience with late-stage upstream process development, PPQ strategy, tech transfer and BLA authoring
  • Strong knowledge of regulatory expectations for process validation and control strategies.
  • Excellent communication, leadership, and cross-functional collaboration skills.
  • Demonstrated ability for taking initiative, creativity, and innovation in problem solving
  • Experience working with novel large molecule formats such as bispecific antibodies and Fusion proteins/enzymes is a plus
  • Demonstrated technical writing, critical thinking, scientific problem-solving and communication skills
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About Cedent

Sourced by ZipRecruiter

CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.

Industry

It services

Company size

11 - 50 Employees

Headquarters location

Plano, TX, US

Year founded

2008

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