Associate Director, Technical Project Leader Drug Product

Position

Festanstellung

Director

Ingenieurwesen

Konditionen

Basel, Switzerland

100%

Endet in 30 Tagen

Anforderungen

10+ J. Erfahrung

Doktortitel

EU/EFTA-Bewilligung

Sprachen

Englisch C2

Beschreibung

Job Responsibilities

The Technical Project Leader Drug Product will lead the technical development of several oral solid dosage forms, from early phase to late phase development activities, including formulation development and production scale up with external partners.

Aufgaben

Lead and manage development, analysis and production of solid dosage forms, including clinical and market forms
Lead the technical drug product development activities (in house or external): plan, organize and administer the different aspects of the technical activities required for development, scale-up, validation and manufacturing of a drug from development up to commercial supplies
Lead the collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality
Support the development, communication and execution of the overall CMC strategy
Act as Subject Matter Expert for Drug product manufacturing activities, focusing on technologies required for the selected development programs.
Ensure sufficient and timely supplies for development projects based on input from the CMC, Project and/or Life Cycle management and Global Supply Chain functions
Ensure compliance with regulatory guidelines

Anforderungen

Pharmacist or Equivalent with PhD
Minimum of 10 years job relevant working experience in the pharmaceutical industry
Minimum of 5 years of leading of an interdisciplinary drug product team
Scientific expertise in small molecule formulation development
Scientific expertise in oral solid dosage forms (conventional dosage forms), experience in Lipid Based Formulations and/or Amorphous Solid Dispersions is a plus
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)

Vorteile

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success.
We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees.

Unternehmen

Idorsia

Pharmaceuticals

The purpose of Idorsia is to discover, develop, and commercialize innovative medicines to help more patients. Headquartered in Switzerland – a biotech-hub of Europe – Idorsia is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.