Gene Therapy Drug Product Scientist - Manufacturing

Scorpion Therapeutics; Lebanon (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

401(k)

Medical/dental/vision

Life insurance

Time off/leave

Well-being benefits

Job summary

Scorpion Therapeutics in Lebanon, IN is seeking a Drug Product Bioprocess Scientist – Technical Services/Manufacturing Scientist to provide technical support for development, implementation, and compliant manufacturing of gene therapy drug products, focusing on formulation, media and buffer prep, filling, packaging, and visual inspection from startup through validation and commercial production.

The role requires applying chemical and aseptic processing principles, leading cross-functional

Qualifications

• BS in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or related quantitative field.
• 3+ years cGMP manufacturing experience (Operations, Validation, TS/MS, Engineering, or Quality Assurance)
• 3+ years parenteral drug product manufacturing (formulation, tech transfer, visual inspection, statistical trending/analysis, process risk assessment e.g. FMEA)

Responsibilities

• Provide technical support for TS/MS activities (tech transfer, process validation, investigation, media & buffer recipe, formulation, filling & packaging, visual inspection).
• Apply scientific principles for gene therapy drug product manufacturing (chemistry, equipment, aseptic processes, container closure systems).
• Address and resolve formulation issues.
• Own/steer media and buffer preparation formulations.
• Prepare/review/approve technical documents (change controls, regulatory submissions, deviation investigations, validation protocols & summary reports, processing records, process descriptions, annual reports).
• Support/lead TS/MS technical projects to improve startup, process control, yield, product quality and/or productivity; implement technical process changes.
• Develop/monitor statistically based real-time process variability/capability metrics.
• Support daily manufacturing operations via process knowledge and data analysis.
• Serve as technical interface external to the Lebanon site; provide audit support as needed.
• Work/lead cross-functional teams; ensure safe working environment.

Skills

Data analysis

Cross-functional leadership

Interpersonal teamwork

Oral/written communication

Statistical trending/analysis

Education

BS in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or related quantitative field

Job description

Scorpion Therapeutics in Lebanon, IN is seeking a Drug Product Bioprocess Scientist – Technical Services/Manufacturing Scientist to provide technical support for development, implementation, and compliant manufacturing of gene therapy drug products, focusing on formulation, media and buffer prep, filling, packaging, and visual inspection from startup through validation and commercial production.

The role requires applying chemical and aseptic processing principles, leading cross-functional