Program Manager Drug Substance

Job profile

Job profile

As a program manager drug substance you are focused on Research & Development projects where we make use of external drug substance suppliers or contract manufacturers. You translate our evolving R&D requirements into a clear set of specifications for the drug substance and support technical information of available material in the market and align with suppliers on Synthon’s requirements.

You will work extensively with various disciplines within the Research and Development team, Quality Control, Quality Assurance, Intellectual Property, our API Procurement team within Operations as well as with our external supplier and its responsible departments. You will provide full technical support to our procurement team and contribute from an R&D perspective to the vendor selection. You are part of the R&D development team as drug substance expert, being responsible for the technical link between the team and the supplier.

Job mission

To accurately identify Synthons Research & Development requirements and translate them into a clear set of specifications. Be the primary contact person within R&D for all technical questions as to the drug substance purchased at external suppliers or produced by external contract manufacturers.  Provide support to our procurement team to select and qualify our suppliers.

The role requires extensive interaction with multiple internal and external stakeholders at multiple levels of our global organization, spanning throughout the early phase of a product lifecycle, all the way from early project opportunity evaluation to product registration and up to commercial launch.

Job details

- Work with multiple stakeholders to properly define the GMP materials and information required by the project team. 

- Align with departments like our intellectual property, analytical, chemical and pharmaceutical R&D and procurement to screen the material of possible suppliers.

- Align with our suppliers on technical topics chemical and physical properties i.e. impurity profile, particle size, solubility, polymorphs.

- Support the procurement process for R&D direct materials for supplier selection and qualification. Here you work closely together with our purchasing team.

- Develop and maintain supplier relationship to ensure on-time delivery of drug substance to our required quality.

- Assess ongoing quality risks to supply and take actions to mitigate these.

- Align with our analytical departments and the supplier to arrange on time method transfer.

- Ensure seamless transfer and progression of project from R&D to commercial supply.

- Support the wider R&D organization with the provision of the information required for product development and registration.

Your profile

Requirements 

  • Bachelor or Master's degree in Chemistry, Analytical Chemistry, Biochemistry or similar 
  • 5+ years of experience of working within the pharmaceutical industry  
  • Relevant experience in Project Management
  • A knowledge of GMP Regulations, and of Chemical Production and R&D would be an advantage. 
  • Excellent communication and people management skills
  • A high proficiency in English both in writing and speaking

Personal skills

You are energetic, pragmatic and able to work autonomously with positive energy and a pro-active attitude. You have strong analytical skills; you collect and analyze information, problem solve and make decisions.

To bring your projects to a successful end, you are committed to deliver in time, result oriented and you love working with colleagues of many different disciplines. You are a clear team player.

Application

Our offer

We offer our employees a working environment in which trust, pride and joy play an important role and as such we have been acknowledged as a Great Place to Work® in 2017 and 2019.  We understand our economic, social and environmental impact on the wider world. We care - for each other, for partners, for patients and for society at large. We support various educational initiatives and actively contribute to charitable causes and to the development of the communities worldwide to which we belong.

More specifically, we offer our employees:

  • A professional, yet pleasant and informal working environment with short communication lines, focus on cooperation and appreciation of initiatives
  • Competitive remuneration
  • Good working conditions with attention to ergonomic support
  • A keen eye on work/life balance, with the option to partly work from home
  • A yearly outing with all colleagues and other inspiring company events.

Application and important dates

If you are interested in this fulltime position and you would like to join our company, we look forward to your application. You can apply via our website www.synthon.com/careers. Please send your application before 31 May 2021. The first round of interviews will take place on Thursday 3 June. The second round will be held on half June 2021.

Contact

For further information, please contact Sandy Verhaegen, Hans Hoorn or Saskia Hendrickx, at tel. +31(0)24 37 27 700.

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