Drug Substance Program Manager Oligonucleotides

Job

The Drug Substance (DS) program manager is responsible for facilitation of the technical DS scope for the development of generic medicines, which includes, but is not limited to, process and method development, manufacturing and packaging. You are directly responsible for management of scope, schedule, budget and risk with regard to the DS research and development activities related to oligonucleotides. You are responsible for all project management deliverables relating to the extent of CMC activities for a specific program, including risk management deliverables. You understand the overall program risk register, regularly review CMC risks with the team, track and evaluate potential CMC risk triggers, conduct impact analysis, help define mitigation and contingency strategies, and support in drafting stakeholder communications. You will partner with CMC technical leads to facilitate the planning and execution of the CMC deliverables. This includes all aspects of process development, such as analytical control strategies, manufacturing and packaging, throughout the lifecycle of the program. As program manager, you will closely work together with the Global Project Management organization to help establish and maintain tools, templates and processes for management of scope, schedule, budget, risk and reporting. The position requires international travel to some extent.

Profile

Your letter of motivation and CV show that you have:

  • A Ph.D. or equivalent education with a minimum of 5 years’ experience in a technical drug development CMC role
  • A minimum of 5 years’ experience in a project management role overseeing CMC-related effort within a DS or related organization
  • Relevant knowledge of and experience with oligonucleotides
  • An excellent command of the English language (in writing and speaking).

Previous experience in establishing effective working relationships in a project environment is a plus.

In interviews you will be able to demonstrate that:
You have experience in functionally leading a team. You have demonstrable organizational skills, strong verbal and written communication skills, and an eye for detail. You are able to work independently but you can also work effectively in a global team with changing timelines and priorities. You understand how all the CMC functions come together in the integrated CMC plan and how CMC fits into the overall product development strategy. 

Benefits

Contract hours: at least 32 hours.
Salary: scale 18.
Location: Nijmegen.

Company profile

Synthon Generics is an international pharmaceutical company, and a leader in the field of generic human medicines. Founded in 1991, Synthon Generics works to develop therapies that address the needs of people worldwide and help improve their health and well-being. Through the provision of high-quality generic medicines, we make treatments more affordable and increase access to important remedies. Currently, our products are approved by regulatory agencies in more than 90 countries and marketed through strategic partnerships and – in dedicated areas – through direct sales.

Synthon Generics’ head office is based in Nijmegen, the Netherlands, and the company has affiliates in eight other countries. The company employs around 1,600 staff of whom around 200 work in Nijmegen.

We are interested in result-oriented people with a sharp mind and entrepreneurial spirit, who can contribute to our ambition to provide solutions to the healthcare challenges of today and tomorrow.

Contact

For more information, please contact Hans Hoorn, chief scientific officer, at tel. +31 (0)24 372 77 00. If you are interested in this challenging position, we look forward to your application. You can apply via the apply button / link.

Important dates
Please send your application before 5 September 2019. Interviews will take place in the second week of September 2019.

Location

Nijmegen

Company

Synthon B.V.

Publication date

16.08.2019

Publication end date

15.10.2019

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