Strategic CMC Product Development Director

Scorpion Therapeutics; United States; On-site; USD 160,000 - 220,000; Full time

Job summary

Scorpion Therapeutics seeks a senior CMC leader to guide development across drug substance and product, analytical development, and regulatory interactions. You will chair cross-functional teams, drive governance, and align CMC strategy with clinical and portfolio goals.

The role emphasizes risk management, IND/NDA readiness, and collaboration with external partners, requiring strong communication and a track record with ICH FDA EMA MHRA guidelines.

Qualifications

• Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or related field with 10+ years CMC development experience; or MS with 15+ years CMC development experience.
• Experience: small molecule API, formulation development, analytical development, product development (pre-clinical to commercial).
• Strong verbal communication; strong knowledge of technical regulatory requirements/trends (ICH, FDA, EMA, MHRA).
• Demonstrated project/program management, governance, and risk management.
• Preferred: experience leading CMC team through IND and NDA/MAA.
• Skills: negotiating/influencing, collaboration, scientific writing, pharmaceutical/chemical/analytical development knowledge; CMC interdisciplinary experience in oral solid, small molecule space; enterprise thinking and business acumen; experience across asset modalities desirable.

Responsibilities

• Represent CMC in governance forums; advocate for CMC; ensure transparent governance, cross-functional ownership, bi-directional communication, and proactive risk mitigation for assigned programs.
• Lead cross-functional CMC product development team meetings and ensure information flow between CMC and program/portfolio governance forums.
• Critically evaluate and integrate raw materials, drug substance, and drug product inputs into development strategies aligned with corporate business objectives.
• Lead/manage one or more CMC project teams; contribute to portfolio-level prioritization; negotiate for resources; influence project timelines to complete required activities.
• Mentor functional representatives; provide feedback to functional managers and identify team growth needs.
• Lead and execute fully integrated product development strategy supporting clinical trials and regulatory approval.
• Support continuous improvement of the CMC Development Roadmap and Governance within the GSC&TO Program Management framework.
• Serve as CMC Lead on high-profile partnerships/collaborations and at the Joint Development Committee.
• Proactively communicate plans and risks to senior leadership through regular updates and periodic reviews.
• Lead/execute in alignment with ICH and applicable contemporary regulatory requirements.

Skills

Verbal communication

Negotiation

Collaboration

Regulatory knowledge

Education

Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or related field

M.S. with 15+ years CMC development experience

Job description

Scorpion Therapeutics seeks a senior CMC leader to guide development across drug substance and product, analytical development, and regulatory interactions. You will chair cross-functional teams, drive governance, and align CMC strategy with clinical and portfolio goals.

The role emphasizes risk management, IND/NDA readiness, and collaboration with external partners, requiring strong communication and a track record with ICH FDA EMA MHRA guidelines.