Executive Director, DS Chemistry & Process Development

Madrigal Pharmaceuticals Inc.; Conshohocken (Montgomery County); Sur place; USD 276 000 - 329 000; Plein temps

Avantages offerts par ce poste

Equity

Résumé du poste

Madrigal Pharmaceuticals Inc. seeks an experienced leader for DS process strategy and development, overseeing external manufacturing and tech transfer to CDMOs.

You will drive impurity strategy, optimize routes, and coordinate cross-functional teams to ensure robust, regulator-ready CMC documentation. The role emphasizes scale-up, process safety, and lifecycle readiness, with cross-functional collaboration across Analytical Development and Engineering, contributing to a high-performing,

Qualifications

• BS+ in Chemistry or related field; PhD preferred.
• 18+ years in process chemistry/DS with external manufacturing support.
• Leadership of route development, impurity strategy, and tech transfer.
• Strong technical writing and cross-functional leadership.
• Experience with polymorph/solid-form implications for DS/DP interface.

Responsabilités

• Define DS route and RSM strategy aligned with phase-appropriate control strategy.
• Approve DS R&D plans (optimization, robustness, impurity investigations).
• Ensure DS deliverables support clinical supply builds and lifecycle readiness.
• Lead DS tech transfer expectations and readiness criteria for CDMOs; oversight for deviations, investigations, CAPA, and change impacts.
• Provide DS inputs and rationales for CMC documents and health authority responses; partner with Analytical and Engineering for scale-up and safety.

Connaissances

Leadership

Tech transfer

CDMO governance

Process chemistry

Impurity strategy

Formation

BS+ in Chemistry or related (PhD preferred)

Description du poste

Madrigal Pharmaceuticals Inc. seeks an experienced leader for DS process strategy and development, overseeing external manufacturing and tech transfer to CDMOs.

You will drive impurity strategy, optimize routes, and coordinate cross-functional teams to ensure robust, regulator-ready CMC documentation. The role emphasizes scale-up, process safety, and lifecycle readiness, with cross-functional collaboration across Analytical Development and Engineering, contributing to a high-performing,