Technical Project Leader in Chemical Development API

Location: 

Basel Area-Allschwil, BL, 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.

 

Job Responsibilities

  • Lead and manage development, analysis and production of drug substances (API): plan, organize and administer the different aspects of the technical activities required for development, scale-up, validation and manufacturing of a drug from preclinical development to late stage clinical development
  • Maintain contact and seek support of other internal technical functions to ensure comprehensive and adequate technical development
  • Ensure sufficient and timely API supplies based on input from the Planning & Procurement function, CMC, Project and Life Cycle Management and on technical and scientific input from Chemical Process R&D
  • Identify and select partner companies for technical development and API production
  • Manage, monitor and track the partners with special emphasis on cost efficiency, timelines, compliance, and scientific quality within the supplier portfolio management
  • Negotiate general, financial and technical agreements with the contractors supported by internal partners
  • Support GQM to audit selected partners and to control cGMP status.
  • Ensure a seamless learning and know-how curve by maintaining a close-knit collaboration with Chemical Process R&D
  • Represent Chemical Development in Due Diligence teams.

 

Candidate’s Requirements

  • Chemist or Chemical Engineer with PhD
  • Minimum 5 years of relevant experience in the pharmaceutical or chemical industry with at least 2 years of successful performance in the role of leading interdisciplinary teams of scientists working in pharmaceutical development and/or commercial projects
  • Scientific expertise in the drug substance (API) development and manufacturing
  • Profound knowledge of GMP, quality control and regulations governing pharmaceutical development and production
  • Experience in the API development process, essentially in early clinical phase (Phase 1 to Phase 2)
  • Experience in process validation and registration is a plus
  • Ability to negotiate, plan, and coordinate technical development and manufacturing activities
  • Very good communication skills
  • Excellent English required (oral and written)
  • Excellent know-how of the pharmaceutical custom manufacturing market
  • Ability to deliver against challenging time and quality goals

 

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: Allschwil

Country: Switzerland

Business Area: Chemical Development API

Schedule: Fulltime

Job Type: Permanent

Job ID: 1068

 

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.

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