Associate Director, Technical Ops — Small Molecule CMC

Scorpion Therapeutics; United States; On-site; USD 170,000 - 230,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plan with company match

Generous paid time off

Job summary

Scorpion Therapeutics is seeking an Associate Director of Technical Operations (Small Molecule CMC) to provide technical oversight for API development and manufacturing at CDMOs in the United States. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to drive milestone achievement and lifecycle management.

You will review manufacturing documentation, support GMP systems, and author regulatory content while ensuring US/EU GMP alignment and strategic objectives for

Qualifications

• 8+ years in late-phase development, scale-up and commercialization.
• Expert knowledge of small molecule API process development and PPQ.
• Experience overseeing CDMOs and contract testing labs (global preferred).

Responsibilities

• Provide technical oversight of API production, scale up, and PPQ for solid oral drug products.
• Review manufacturing documentation: change controls, batch records, tech transfer, validation reports.
• Verify qualification and validation status of CDMO processes.
• Support GMP quality systems: deviations, CAPAs, regulatory submissions, inspections.
• Collaborate on CMC development, clinical supply, and lifecycle management.
• Author/review regulatory content (INDs, IMPDs, NDAs).
• Maintain knowledge of US/EU GMP and ICH guidelines.
• Review scope and timelines to meet objectives.

Skills

Strong communication

Attention to detail

Collaboration

Six Sigma

Travel willingness

Education

BS in chemistry/biochemistry/pharmaceutical science/chemical engineering or related life sciences

MS/PhD preferred

Tools

Process characterization

PPQ understanding

Job description

Scorpion Therapeutics is seeking an Associate Director of Technical Operations (Small Molecule CMC) to provide technical oversight for API development and manufacturing at CDMOs in the United States. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to drive milestone achievement and lifecycle management.

You will review manufacturing documentation, support GMP systems, and author regulatory content while ensuring US/EU GMP alignment and strategic objectives for