Manager Analytical Development Drug Substance

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

 

  • Responsible for the management of a group in the GMP laboratory
  • Responsible that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines
  • Development, optimization and validation of analytical methods for new preclinical candidates, clinical candidates, and commercial products
  • Establishment of specifications and of analytical profiles for lNDs and NDA’s
  • Planning, coordinating and directing GMP quality control operation associated with GMP analytical tasks (e.g. release analysis, stability analysis)
  • Assuring laboratory equipment qualification
  • Provide expertise to support actively the company in matters of regulatory requirements, technology and organization
  • Ensuring compliancy for the transfer of analytical methods to the CRO/CMO
  • Representing the department in technical project teams and CMC team meetings
  • Ensuring initial and continuing training of the personnel of AD-QC and adaptation according to business needs
  • Communicating results and product quality issues to management including proposals to solve issues and preventing actions
  • Active participation in internal and external forums and conferences¨
  • Develop and drive the overall analytical project strategy 

 

Candidate’s Requirements

 

  • Chemist or Pharmacist with at least 8 years of GMP experience in the pharmaceutical industry
  • Proven record in managing professionals effectively in a matrix organization
  • In addition to profound skills of the GMP/regulatory requirements, a strong background in analytical chemistry is required as well as extensive expertise in dedicated analytical field
  • Profound scientific knowledge in analytical development.
  • Ability to perform in a highly dynamic environment
  • Strong communication skills and experience in dealing with external clients, partners as well as Health Authorities
  • Proven organizational skills; Ability to handle multiple projects and exercise good judgment in prioritizing tasks, and excellent organizational skills
  • Successful experience on developing and delivering analytical methods/SOPs
  • Experience in CMC analytical and regulatory requirements, including development of specifications and extended analytical characterization
  • Experience in interacting with CROs/CMOs is preferred
  • Excellent communication, interpersonal and advocacy skills
  • An enthusiastic, self-motivating and committed approach to delivering high quality results, and the confidence and flexibility to do this in a demanding environment
  • Excellent command of English
  • Willingness to limited travel

 

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Pharmaceutical Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1093

 

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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