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Upstream Process Development Jobs (NOW HIRING)

Agilent

Process Engineer, Upstream

Frederick, CO · On-site

$124.16K - $194K/yr

Technical lead for upstream processes and unit operations. Responsible for process modeling and ... Support Chemical Development in the development, characterization, and scaleup of innovative ...

Merck & Co.

Our vaccines upstream process development team develops safe, scalable, robust, cost-effective upstream processes that enable clinical and commercial manufacture of vaccines and adjuvants across all ...

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How much do upstream process development jobs pay per hour?

As of May 30, 2026, the average hourly pay for upstream process development in the United States is $26.51, according to ZipRecruiter salary data. Most workers in this role earn between $23.56 and $27.88 per hour, depending on experience, location, and employer.

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

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 upstream process development?

Upstream process development refers to the optimization and scaling of biological production processes that occur before product harvesting. This primarily involves the cultivation of cells or microorganisms to produce a desired product, such as a protein or antibody, in bioreactors. Scientists in this field work on improving cell lines, culture media, and fermentation conditions to maximize yield and quality. Upstream process development is a critical early phase in biomanufacturing, laying the foundation for downstream processing and overall production efficiency.

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.

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Upstream Process Development jobs near you
Infographic showing various Upstream Process Development job openings in the United States as of May 2026, with employment types broken down into 25% Temporary, and 75% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $55,150 per year, or $26.5 per hour.
Manager / Sr Manager CMC Product Management - Upstream

Manager / Sr Manager CMC Product Management - Upstream

RAY THERAPEUTICS INC

Berkeley, CA • On-site

$130K - $145K/yr

Full-time

Posted 3 days ago

Job description

Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications. Ray Therapeutics is based in the San Francisco Bay Area.

We are currently seeking a highly motivated and technically strong Manager/Sr. Manager, CMC Product Management - Upstream to join our growing organization. This role will support the development and execution of upstream process and manufacturing strategies across early and late-stage AAV gene therapy programs.

The position is ideal for candidates with strong hands-on experience in viral vector upstream process development, manufacturing operations or MS&T who are interested in applying their technical expertise in a cross-functional CMC role.

The successful candidate will work closely with internal CMC teams, Quality, Regulatory and external CDMOs to drive upstream lifecycle activities, technical oversight, manufacturing readiness, and regulatory execution. This role requires strong technical acumen in upstream viral vector manufacturing operations and the ability to work effectively across internal and external teams.

The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require travel to our contract development and manufacturing organizations in the United States.


Essential Duties and Responsibilities:

  • Support execution of RayTx’s CMC product lifecycle activities across development stages, including upstream process development, risk assessments, process characterization, scale-up, technology transfer, manufacturing support and regulatory submissions.
  • Serve as a technical and operational liaison between internal teams and external CDMOs for upstream development and manufacturing activities.
  • Collaborate closely with upstream process development, MS&T, manufacturing and analytical teams to monitor process performance, track manufacturing trends, assess process risks, drive process optimization and continuous improvement initiatives.
  • Support technical oversight and support for AAV upstream manufacturing operations including cell expansion, transfection, bioreactor operations, etc.
  • Review and provide input on GMP documentation including, but not limited to master production records, SOPs, technical reports, test procedures, deviations and, CAPAs.
  • Track CMC deliverables, timelines, manufacturing activities, and communicate status updates to cross functional stakeholders.
  • Support preparation and review of CMC sections for regulatory filings (IND, CTA, BLA, MAA) and ensures adherence to GMP and ICH guidelines.


Qualifications and Experience:

  • Must have a degree in relevant scientific or engineering discipline with 8+ years relevant biotech experience.
  • Hands on technical experience in viral vector Upstream Process Development, manufacturing operations and/or MS&T support.
  • Experience in supporting risk assessment, process characterization, scale-up, technology transfer preferred.
  • Working knowledge of GMP manufacturing operations and batch execution preferred.
  • Experience working with CDMO and external vendors preferred.
  • Familiarity with viral vector analytical methods and upstream process performance metrics preferred.
  • Familiarity with GMP regulations, ICH guidelines and regulatory CMC documentation
  • Strong organizational, communication, and technical problem-solving skills.
  • Ability to effectively manage multiple priorities in a fast-paced environment.

Compensation Range and Benefits:

  • For this role, the anticipated base salary range: $140,000 to $160,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience. 
  • Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package. 

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

  All employment is decided on the basis of qualifications, merit, and business need.


Search Firm Representatives Please Read Carefully

Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of Ray Therapeutics.

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