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Principal Scientist Upstream Process Development Jobs

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Principal Scientist Upstream Process Development information

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$68.5K

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How much do principal scientist upstream process development jobs pay per year?

As of Sep 11, 2026, the average yearly pay for principal scientist upstream process development in the United States is $144,009.00, according to ZipRecruiter salary data. Most workers in this role earn between $117,500.00 and $169,000.00 per year, depending on experience, location, and employer.

What does a principal scientist in upstream process development do?

A Principal Scientist in Upstream Process Development leads the design, optimization, and scale-up of processes for producing biologics such as proteins or vaccines using living cells. They oversee experimental strategies to improve cell culture performance, maximize yield, and ensure product quality. This role often involves mentoring junior scientists, collaborating with cross-functional teams, and ensuring that upstream processes comply with regulatory requirements. Their expertise is critical in advancing drug candidates from research through clinical and commercial manufacturing.

What are the key skills and qualifications needed to thrive as a principal scientist in upstream process development?

To thrive as a Principal Scientist in Upstream Process Development, you need advanced expertise in cell culture, biochemical engineering, and process optimization, typically supported by a PhD in a relevant scientific field and several years of industry experience. Proficiency with bioreactor systems, data analysis software (such as JMP or MATLAB), and knowledge of regulatory standards (like cGMP) are essential. Strong leadership, project management, and effective communication skills distinguish top performers in this role. These competencies ensure innovation, compliance, and successful scale-up of bioprocesses critical to biologics manufacturing.

What are some typical challenges faced by principal scientists in upstream process development, and how can they be addressed?

Principal Scientists in Upstream Process Development often encounter challenges such as optimizing cell culture conditions for high yield and quality, scaling up processes from lab to production scale, and troubleshooting unexpected process deviations. These challenges require strong problem-solving skills, close collaboration with cross-functional teams (such as downstream processing, analytical development, and manufacturing), and staying current with technological advancements. Proactively designing experiments, leveraging data analytics, and fostering open communication across departments can help address these hurdles and ensure process robustness.

What are popular job titles related to Principal Scientist Upstream Process Development jobs?

For Principal Scientist Upstream Process Development jobs, the most frequently searched job titles are:

Infographic showing various Principal Scientist Upstream Process Development job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 81% Full Time, 15% Part Time, and 2% Contract. Highlights an 85% Physical, 3% Hybrid, and 12% Remote job distribution, with an average salary of $144,009 per year, or $69.2 per hour.

Sr/Principal Scientist - Upstream Process Development

Indianapolis, IN

Genezen
Biotechnology Research and Development • 51 - 200 employees

Full-time

Re-posted 27 days ago


Job description

JOB SUMMARY

The Sr./Principal Scientist, Upstream Process Development will be part of the Process Development Group reporting to the Director of Process Development. The role will have direct management responsibility for a team of Scientists and Research Associates. TheĀ Sr/Principal ScientistĀ isĀ responsibleĀ forĀ theĀ Upstream ProcessĀ development,Ā characterization,Ā technologyĀ transferĀ and GMP manufacturing technical support. ThisĀ individualĀ willĀ leadĀ orĀ contribute asĀ aĀ coreĀ memberĀ ofĀ variousĀ cross-functionalĀ teams, and interactĀ extensivelyĀ withĀ otherĀ departments within Genezen,Ā includingĀ AnalyticalĀ Development, Manufacturing,Ā Engineering, and MSAT. This is a client-facing position with regular interaction with our partners including external presentations, driving the technical discussion and program strategy.

JOB RESPONSIBILITIES

  • Provides technical oversight and strategic input for upstream viral vector drug substance development activities
  • Leads, proposes, manages, and coordinates activities on platform improvement/continuous projects in USP labs
  • Leads, manages, and supports late-stage development, by identifying tasks, planning, monitoring progress of deliverables, and in terms of protocol and report generation in areas such as scale-down model qualification, process characterization, and scale-down model process validation studies
  • Leads and supports technology transfer activities at pilot plant and when necessary, preforms experiments him/herself, focusing scale-up platform process at scale and process improvements implementation, process characterization at scale and bills of materials as well as sampling plans.
  • Provides MSAT and manufacturing technical Upstream SME support for process troubleshooting, manufacturing data analysis, root cause analysis, and deviations during GMP production, change controls, CAPAs, CCRs and other Quality Systems documentation as needed.
  • Designs and outlines experimental plans to meet the defined Genezen and client objective. Analyses and reviews experimental results and data.
  • Performs, optimizes, and maintains linear scale-down models. Writes, reviews, and approves electronic lab notebooks (ELNs) entries, experimental protocols, development reports, process descriptions, and scientific reports
  • Presents project progress and results internally to cross-functional teams and externally to clients/stakeholders
  • Maintains robust communication with all relevant functions that have an impact on or are impacted by Upstream Process Development
  • Coordinates and supervises the activities in the USP labs (with a team of engineers/ (Jr.) bioprocess technologist, co-op students, interns, temporary personnel (contractors), and technical SMEs and when necessary, performs experiments him/herself. Guides junior USP team members by setting goals/tasks on projects

SPECIAL JOB REQUIREMENTS

  • Adaptability required as work schedule may change based on business needs
  • Criminal background check required
  • Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

MSc with 8+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines

Essential

PhD with 6+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines

Desired

ON-THE-JOB EXPERIENCE

Ā 

Process Development and Cell Line Development Experience

Essential

Upstream Processing Experience with Cell Culture, Bioreactor Technologies, and Transfection/Infection approaches

Essential

Prior work experience at a CDMOĀ 

Desired

SKILLS / ABILITIES

Ā 

Hands-on experience on complex biologics, e.g. gene therapy, viral vaccines, therapeutic proteins

Essential

Experience with technology transfer and GMP manufacturing technical support

Essential

Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems

Essential

Effective communicator with track record of presenting data to relevant stakeholders including external stakeholders

Essential

Experience with DoE design and statistical analysis on large data sets

Essential

Excellent scientific writing skills demonstrated by publications and reports

Essential

Experience with direct management of Scientists and Research Associates including day-to-day oversight and direction and career development and coaching.

Essential

PHYSICAL DEMANDSĀ 

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

  • Regularly sit for long periods of time

Movement

  • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

  • Frequently lift and/or move up to 10 pounds
  • Rarely lift and/or move up to 25 pounds

Vision

  • Frequently utilize close vision and the ability to adjust focus

Communication

  • Frequently required to communicate by talking, hearing, using telephone and e-mail