Senior Technical Project Leader, Drug Substance Development

Idorsia Pharmaceuticals Ltd; Basel; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Idorsia Pharmaceuticals Ltd in Basel Area is seeking an Associate Director, Technical Project Leader Drug Substance to lead the technical development of several drug substances from early phase to commercial supply, overseeing development, analysis, and scale‑up activities.

You will collaborate with external partners, ensure GMP compliance, define CPPs/CMAs, manage risk mitigation, and drive cross‑functional alignment with Drug Product teams; a Master/PhD with ≥5 years in pharma is preferred.

Qualifikationen

• Chemist, Chemical engineer or equivalent with Master or PhD (preferred) with minimum 5 years of relevant experience in the pharmaceutical industry.
• Minimum of 2 years of leading of an interdisciplinary drug product team.
• Scientific expertise in Drug Substance development and / or Manufacturing.
• Experience in setting development and regulatory drug substances strategies for products in development.
• Profound knowledge of GMP, quality control and pharmaceutical development and/or production processes, based on current guidelines.
• Profound knowledge in QbD, DOE and QRM.
• Ability to negotiate, plan, and coordinate technical development and manufacturing activities.
• Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics.
• Excellent English required (oral and written).

Aufgaben

• Lead the technical development of drug substances from early to late phase development up to commercial supplies.
• Lead manufacturing and scale‑up activities toward API including supplies of building blocks and GMP intermediates.
• Lead technical transfer for drug substance processes and define CPPs and CMAs.
• Coordinate development activities for development, scale‑up, validation and manufacturing of a drug.
• Collaborate with external development partners focusing on cost efficiency, timelines and quality.
• Work with Drug Product teams to address physico-chemical requirements for the DS.
• Develop and execute risk mitigation plans for drug substance supplies.
• Ensure compliance with regulatory guidelines including new initiatives (e.g., nitrosamines risk assessment).
• If needed, assume responsibilities of API safety project leader.

Kenntnisse

Leadership

Project management

Interpersonal skills

English (excellent)

Ausbildung

Master or PhD (preferred)

Tools

GMP knowledge

Jobbeschreibung

Idorsia Pharmaceuticals Ltd in Basel Area is seeking an Associate Director, Technical Project Leader Drug Substance to lead the technical development of several drug substances from early phase to commercial supply, overseeing development, analysis, and scale‑up activities.

You will collaborate with external partners, ensure GMP compliance, define CPPs/CMAs, manage risk mitigation, and drive cross‑functional alignment with Drug Product teams; a Master/PhD with ≥5 years in pharma is preferred.