Associate Director, Technical Project Leader Drug Product

Location: 

Basel, BS, CH

 

 

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 late-stage development and commercial oral dosage forms and lead the drug product development of various oral products entering our clinical pipeline
 
 

Job Responsibilities


The Associate director, Technical Project Leader Drug Product will lead the technical development of several oral solid dosage form products, from late phase development activities (Phase 3) up to commercialization, including formulation development and production scale up with external partners
 

  • Lead and manage development, analysis and production of solid dosage forms, including clinical and market forms
  • 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 development (late stage - Phase 3) up to commercial supplies
  • Support the development, communication and execution of the overall CMC strategy
  • 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, especially with late-stage development (Phase 3) and / or Registration/process Validation/launch phase 
  • 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
  • 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 environment 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: 3476

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.