Senior Process Development Engineer - Upstream

Scorpion Therapeutics; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Process Development Engineer to advance upstream biologics processes from seed train through primary recovery in microbial systems. You will design and optimize scalable workflows using E. coli, P. pastoris, and B. subtilis within GMP frameworks.

You will lead process transfers, troubleshooting, and cross-functional coordination with analytical, formulation, QC, and regulatory teams, while ensuring compliant documentation and leadership updates.

Qualifications

• Bachelor's degree in engineering or equivalent experience.
• 8+ years of industry experience with at least 5 years in GMP, development, or manufacturing environments.
• Hands-on expertise in seed train, fermentation, centrifugation, cell lysis, and filtration at lab to pilot scale.
• Familiarity with cGMP documentation and process transfers.

Responsibilities

• design, execute, and optimize scalable, high-yield, high-purity microbial processes (E. coli, P. pastoris, B. subtilis)
• support process transfer, validation, and manufacturing troubleshooting
• review GMP documentation
• lead process changes
• serve as USP representative on CMC teams
• coordinate with downstream, analytical, formulation, QC, and regulatory functions
• prepare technical updates for leadership and external partners

Skills

seed train

fermentation

centrifugation

cell lysis

filtration

Cross-functional communication

Education

Bachelor's in engineering or equivalent experience

Tools

Sartorius systems

DeltaV

ABB

Job description

Role

Senior Process Development Engineer in upstream biologics process development, focusing on microbial upstream activities from seed train through primary recovery.

Responsibilities

• design, execute, and optimize scalable, high-yield, high-purity microbial processes (E. coli, P. pastoris, B. subtilis)
• support process transfer, validation, and manufacturing troubleshooting
• review GMP documentation
• lead process changes
• serve as USP representative on CMC teams
• coordinate with downstream, analytical, formulation, QC, and regulatory functions
• prepare technical updates for leadership and external partners

Requirements

• Bachelor's in engineering or equivalent experience
• 8+ years industry experience with at least 5 years in GMP, development, or manufacturing environments
• hands‑on expertise in seed train, fermentation, centrifugation, cell lysis, and filtration at lab to pilot scale
• proficiency with Sartorius systems and control software (e.g., DeltaV/ABB)
• familiarity with cGMP documentation
• experience supporting engineering/clinical runs and process transfers
• strong cross‑functional communication skills

HighValue

• biologics (upstream microbial)
• process development
• GMP
• process transfer
• cGMP documentation
• cross‑functional collaboration
• global travel up to 50%

WorkSetup

not specified.