Engineer, MS&T – Aseptic Drug Product

Scorpion Therapeutics; Durham (NC); On-site; USD 90,000 - 166,000; Full time

Benefits offered by this job

Salary with incentive potential

Comprehensive benefits (health, life,

401(k) match

Annual equity awards (depending on/var

Job summary

Scorpion Therapeutics, based in Durham, NC, seeks a manufacturing specialist to monitor process performance, lead investigations, and support tech transfer into commercial production. The role emphasizes collaboration with Quality and cross-functional teams to sustain product quality.

Qualified candidates hold a Bachelor’s in a relevant field with 4+ years of biopharmaceutical GMP experience (including aseptic fill-finish) or a Master’s with 2+ years.

Qualifications

• Bachelor's in Biochemistry, Chemical Engineering, Bioengineering, or related field with 4+ years biopharmaceutical GMP manufacturing (including aseptic fill-finish).
• Knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation/qualification principles.
• Experience supporting aseptic drug product manufacturing, MS&T, process engineering, or related technical operations.

Responsibilities

• Monitor and analyze process performance data to support continued process verification and product quality.
• Lead technical investigations and provide scientific expertise to resolve manufacturing process challenges.
• Trend critical quality attributes and process parameters to identify risks and drive improvements.
• Support technology transfer activities for new products and processes into commercial manufacturing.
• Identify and implement continuous improvement opportunities that enhance operational performance.
• Partner with Quality teams to maintain a compliant and inspection-ready manufacturing environment.
• Collaborate with Manufacturing to troubleshoot production issues and ensure reliable product supply.
• Support process changes and improvements with cross-functional Engineering, Validation, and Operations teams.
• Contribute to the startup and implementation of new equipment, software, and manufacturing processes.
• Provide technical support for strategic projects, remediation initiatives, and process optimization efforts.

Skills

GMP manufacturing

Aseptic fill-finish

Technical writing

Cross-functional collaboration

Process troubleshooting

Education

Bachelor's in Biochemistry, Chemical Engineering, Bioengineering, or related field

Master's degree in related field

Job description

Key Responsibilities:

• Monitor and analyze process performance data to support continued process verification and product quality.
• Lead technical investigations and provide scientific expertise to resolve manufacturing process challenges.
• Trend critical quality attributes and process parameters to identify risks and drive improvements.
• Support technology transfer activities for new products and processes into commercial manufacturing.
• Identify and implement continuous improvement opportunities that enhance operational performance.
• Partner with Quality teams to maintain a compliant and inspection-ready manufacturing environment.
• Collaborate with Manufacturing to troubleshoot production issues and ensure reliable product supply.
• Support process changes and improvements with cross-functional Engineering, Validation, and Operations teams.
• Contribute to the startup and implementation of new equipment, software, and manufacturing processes.
• Provide technical support for strategic projects, remediation initiatives, and process optimization efforts.

Essential Requirements:

• Bachelor’s in Biochemistry, Chemical Engineering, Bioengineering, or related field with 4+ years biopharmaceutical GMP manufacturing (including aseptic fill-finish); or 3+ years direct Novartis Gene Therapies experience with aseptic fill-finish; or Master’s with 2+ years relevant aseptic fill-finish or engineering experience.
• Knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation/qualification principles.
• Experience supporting aseptic drug product manufacturing, MS&T, process engineering, or related technical operations.
• Strong technical writing skills for accurate, compliant documentation.
• Proven ability to collaborate across cross-functional teams and communicate with diverse stakeholders.
• Ability to travel up to 10%.

Benefits (explicitly stated):

• Salary expected range: $89,600–$166,400 annually; performance-based cash incentive; eligibility for annual equity awards (depending on level).
• US-based comprehensive benefits (health, life/disability), 401(k) match, time off (vacation, personal days, holidays, other leaves).

Onsite in Durham, NC; no relocation support—apply only if location is accessible.