Associate Director, Technical Project Leader Drug

Vor 2 Tagen


Basel, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

**About Idorsia Pharmaceuticals Ltd**
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an **Associate Director, Technical Project Leader Drug Product** to join our parenteral dosage forms and combination products team and lead the drug product development of various vaccine products entering our clinical pipeline

**Responsibilities**:
The Associate director, Technical Project Leader Drug Product will lead the technical development of several parenteral products, focusing predominantly on vaccine projects from early phase development activities up to commercialization, including formulation development and production scale up with external partners
- Lead and manage development, analysis and production of parenteral dosage forms, including clinical and market forms, predominantly focusing on glycoconjugate vaccines
- Ensure sufficient and timely supplies for development projects based on input from the Global Supply Chain, CMC, Project and/or Life Cycle management functions
- Lead the collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality
- Lead the technical drug product development activities: plan, organize and administer the different aspects of the technical activities required for development, scale-up, validation and manufacturing of a drug from early development up to commercial supplies, predominantly focusing on glycoconjugate vaccines
- Support the development, communication and execution of the overall CMC strategy
- Ensure compliance with regulatory guidelines
- Pharmacist or Equivalent with PhD Minimum of 10 years job relevant working experience in the pharmaceutical industry, especially with vaccine products
- Minimum of 5 years of leading of an interdisciplinary drug product team
- Scientific expertise in parenteral formulations and formulations for combination products
- Scientific expertise in large molecule formulation develop, especially vaccines and glycoconjugate vaccines, as well as small molecule formulation development
- Proven know how of development of dosage forms to be used in combination products would be advantageous
- 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 knowledge (oral and written)
**What Idorsia offers**
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution oriented enviroment where you can make a difference
- An innovative and open culture in a truly multicultural environment
- A competitive salary and generous social benefits
**Work Location**: Basel Area - Allschwil
**Country**: Switzerland
**Business Area**: Global Pharmaceutical Development and Quality Assurance
**Schedule**: Fulltime

**Job Type**: Permanent
**Job ID**: 3335

**Job Types**: Full-time, Permanent


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