Technical Project & CMC 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

 

Technical Project Leader

  • Lead and manage development, analysis and production of drug substances.
  • Ensure sufficient and timely supplies for the market, based on input from the Planning & Procurement, for development projects, based on input from CMC, Project and/or Life Cycle management functions and on technical and scientific input from Chemical Process R&D within Chemical Development.
  • Identify need, requirements and opportunity for technology outsourcing.
  • Identify and select partner companies for the activities necessary for technical development and production.
  • Negotiate general, financial and technical agreements with the contractors supported by internal partners.
  • Monitor the partners with special emphasis on timelines, compliance, scientific quality, and cost-efficiency.
  • Track performance of suppliers (cost of goods, timelines, quality) in the relevant databases to support the supplier portfolio management.
  • Support QA to audit selected partners and to control cGMP status for clinical trial material and commercial product manufacturing.
  • Ensure compliance with regulatory guidelines and adapt to new initiatives.
  • Ensure seamless learning and know-how-curve from early Process Research to the CMO by maintaining a close-knit collaboration with Chemical Process R&D and the suppliers.

 

CMC Leader

  • Lead and manage all technical development and commercial manufacturing activities for both drug substance and drug product for assigned projects by developing and executing the overall CMC-project strategies considering all cross-functional aspects and by ensuring the implementation of the approved strategy within the Life Cycle Team, brand team and with involved third parties.
  • Supply risk management for all CMC activities: assess and mitigate supply risks with the functional experts within the CMC team.
  • Lead, manage and support the CMC-team. Set priorities, mentor and motivate CMC tea members.
  • Ensure optimal communication between CMC team members and between the CMC team and other departments.
  • Compile the Technical Development Plan including the CMC product strategy, and constructively challenge other functional plans. Ensure that overall project plan is considered in the CMC plan.
  • Assess and plan costs and resource needs for the assigned project. Prepare and monitor project plans and budgets and negotiate them with the relevant stakeholders.
  • Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level.
  • Present and communicate the consolidated project status within the Life Cycle Team and other non-technical functions.
  • Represent Chemical Development in Due Diligence teams.
  • Support technical DRA in the preparation and timely availability of all relevant CMC source documents necessary for regulatory filings and health authority responses and provide strategic review of relevant CMC documents.

 

Candidate’s Requirements

  • Chemist or Chemical Engineer with PhD (preferred) and minimum 7 years of relevant experience in the pharmaceutical or chemical industry with at least 2 years of successful performance in the role of leading cross-functional teams in pharmaceutical development and/or commercial projects.
  • Excellent interpersonal and communication skills with the ability to adapt effectively to a rapidly changing environment.
  • Excellent leadership and open personality with proven team spirit to motivate and convince people and demonstrated the ability to influence stakeholders without line authority.
  • Availability and willingness to maintain high transparency and to live a sound success and failure culture to constantly improve overall performance.
  • Experience in setting development and regulatory strategies for products in development.
  • Ability to negotiate, plan, and coordinate technical development and manufacturing activities.
  • Scientific expertise in drug substance development and/or manufacturing.
  • Profound knowledge of GMP, quality control and pharmaceutical development and/or production processes.
  • Experience in QbD, DoE, process validation and registration is a plus.
  • Excellent English required (oral and written).
  • Know-how of the pharmaceutical custom manufacturing market.
  • 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: 1586

 

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.