Senior Scientist, Process Development

Scorpion Therapeutics; Gaithersburg (MD); On-site; USD 114,000 - 182,000; Full time

Benefits offered by this job

Annual bonus

Equity

Job summary

Scorpion Therapeutics is seeking a senior leader in downstream process development to advance monoclonal antibody programs. You will design scale-down models, drive CPP studies, and lead tech transfer for biologics with a focus on process characterization and CMC readiness.

The role requires significant experience in pharma PD/MS&T, strong leadership across disciplines, and willingness to travel domestically and internationally. Join a fast-paced team shaping biotherapeutic development.

Qualifications

• 6+ years in global pharma PD or MS&T for monoclonal antibodies or related biologics.
• Expertise in downstream process development including scale-up and tech transfer.
• Ability to design and execute process characterization studies using scale-down models that inform PPQ strategy.
• Strong understanding of biologics CMC processes including PPQ/BLA readiness; antibody or ADC development preferred.
• Demonstrated technical leadership within cross-functional teams and programs.
• Willing to travel domestically and internationally as required.

Responsibilities

• Develop and qualify scale-down models for downstream purification to support mAb manufacturing.
• Execute studies and FMEA to establish CPPs and PAT ranges for process characterization.
• Lead development and optimization of downstream processes including scale-up and filtration.
• Conduct downstream unit operations: depth filtration, chromatography, viral inactivation/filtration, TFF, formulation.
• Collaborate with cross-functional teams to design experiments and support tech transfers.
• Draft CMC process descriptions, characterization reports and risk assessments; contribute to QA docs.

Skills

Downstream process development

Global pharma PD/MS&T experience

Process characterization studies

Scale-down model design

Cross-functional leadership

Travel willingness

Education

PhD in Biomedical Engineering or Chemical Engineering or Biochemistry (6+ yrs) or MS with 8+ yrs experience

Job description

Your Contribution

• Develop and qualify scale-down models for downstream purification processes to support monoclonal antibody manufacturing
• Execute studies and FMEA assessments to establish critical process parameters and proven acceptable ranges for process characterization
• Lead development, optimization, and characterization of downstream processes, including scale-up, virus/impurity clearance, and resin/membrane lifetime
• Conduct downstream process unit operations such as depth filtration, chromatography, viral inactivation, viral filtration, tangential flow filtration, and formulation
• Collaborate with cross-functional teams to design experiments, analyze results, support technology transfers, and meet project timelines
• Contribute to CMC documentation by drafting process descriptions, characterization reports, QbD risk assessments, and other technical reports
• Drive the creation of best practices and workflows for process development in a fast-paced environment

A Good Match

• PhD in Biomedical Engineering, Chemical Engineering, Biochemistry or related discipline with 6+ years of relevant experience (including post-doctoral training), or MS with 8+ years of industry experience
• 6 years' experience in global pharma PD or MS&T for monoclonal antibodies or related biologics
• Expertise in downstream process development including scale-up and technology transfer
• Proven ability to design and execute process characterization studies using scale-down models that inform PPQ strategy
• Strong understanding of biologics CMC processes including PPQ/BLA readiness; antibody or ADC development preferred
• Demonstrated technical leadership within cross-functional teams and programs
• Willingness to travel domestically and internationally as required

Benefits

• Expected Pay Range: $113,600/year to $181,600/year + benefits, annual bonus & equity