Director, Chemical Development

Scorpion Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks an accomplished chemistry leader to drive technical development of small-molecule drug substances, guiding IND-enabling programs to commercial readiness. You will mentor cross-functional teams, design synthetic routes, optimize processes, and collaborate with CDMOs on GMP scale-up and tech transfer.

Responsibilities include selection of CDMO partners, cGMP document oversight, and developing phase-appropriate control strategies, CQAs, and specs.

Qualifications

• PhD in chemistry or MS with extensive small-molecule drug substance experience.
• Strong background in synthetic chemistry, process development, scale-up and GMP support.
• Knowledge of ICH guidelines and analytical methods.
• Experience authoring CMC regulatory filings is preferred.
• Excellent cross-functional communication and problem-solving abilities.

Responsibilities

• Lead technical development strategy for small-molecule drug substances from IND-enabling through late-stage development and commercial readiness.
• Provide technical leadership for synthetic route design, process optimization, control strategy development, and scale-up/tech transfer to pilot/commercial GMP at CDMO partners.
• Evaluate and select CDMO partners for process R&D, GMP capability, and site visits; support RFP/contracting.
• Oversee cGMP document review/approval (batch records, change controls, deviations, specifications, validation plans/protocols/reports).
• Define phase-appropriate drug substance control strategies (CQAs; specs for starting materials/intermediates).
• Drive safe, robust, scalable, cost-effective process development; conduct process characterization and fate/purge studies.
• Apply QbD and risk assessment across development, validation planning, and lifecycle management.
• Serve as drug substance lead on cross-functional CMC teams; support IND/IMPD and NDA/MAA CMC contributions and Health Authority responses.
• Support validation and commercial readiness (PPQ, continued process verification, lifecycle improvement) and ensure timely drug substance delivery.
• Partner on patent strategy and protect innovations; represent Chemical Development in governance and leadership discussions.

Skills

Synthetic organic chemistry

Process development

CDMO leadership

QbD & risk assessment

Cross-functional leadership

Attention to detail

Communication

Regulatory support

Education

PhD in chemistry

MS in chemistry

Tools

cGMP systems

Job description

Responsibilities:

• Lead technical development strategy for small-molecule drug substances from IND-enabling through late-stage development and commercial readiness.
• Provide technical leadership for synthetic route design, process optimization, control strategy development, and scale-up/tech transfer to pilot/commercial (incl. GMP) at CDMO partners.
• Evaluate and select CDMO partners (process R&D, GMP capability, site visits) and support RFP/contracting.
• Oversee cGMP document review/approval (batch records, change controls, deviations, specifications, validation plans/protocols/reports).
• Define phase-appropriate drug substance control strategies (CQAs; specs for starting materials/intermediates).
• Drive safe, robust, scalable, cost-effective process development; conduct process characterization and fate/purge studies.
• Apply QbD and risk assessment across development, validation planning, and lifecycle management.
• Serve as drug substance lead on cross-functional CMC teams; support IND/IMPD and NDA/MAA CMC contributions and Health Authority responses.
• Support validation and commercial readiness (PPQ, continued process verification, lifecycle improvement) and ensure timely drug substance delivery.
• Partner on patent strategy and protect innovations; represent Chemical Development in governance and leadership discussions.

Qualifications:

• Ph.D. in chemistry with 12+ years small-molecule drug substance experience; or M.S. with 15+ years.
• Strong synthetic organic chemistry; process development, scale-up, and GMP manufacturing support.
• Solid-state properties expertise.
• Hands-on CDMO leadership experience; cGMP/quality systems knowledge.
• Knowledge of analytical methods and ICH; experience authoring CMC regulatory filings.
• Demonstrated cross-functional leadership and communication; problem-solving and attention to detail.
• Preferred: mentoring/matrix team experience.
• Ability to travel domestically/internationally.