Associate Director, Technical Project Leader Drug Product

Idorsia Pharmaceuticals

Basel, Switzerland

We are looking for a Technical Project Leader – Drug Product to join our Drug Product and CMC strategy team to lead the drug product development. Idorsia is currently running development programs for numerous oral products at all clinical phases (I, II & III) as well as managing commercial assets.

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.

Main responsibilities are as follows:

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

Candidate’s Requirements

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)