SEC Recruitment

Manager of Analytical Development and Quality Control

Location
Switzerland
Salary
Negotiable
Posted
19 Aug 2019
Closes
16 Sep 2019
Ref
AA1224DPM
Contact
Akos Erdelyi
Discipline
Quality
Hours
Full Time
Contract Type
Contract
Experience Level
Management
The Company

There is an opportunity to join a dynamic organisation that is a leader in pharmaceutical innovation as a Manager of Analytical Development and Quality Control in Switzerland.

The Role

This is a full-time, contract role. As a Manager of Analytical Development and Quality Control you will be responsible for:
* Strategy development and implementation of analytical strategies for development stage projects
* Identifying analytical science capabilities and technology tools needed to enable sterile manufacturing process development, QC testing, and new drug candidate formulation development for parenteral formulations.
* Managing CRO/CMO for analytical activities
* Reviewing technical documents for regulatory submissions
* Method transfer to contract manufacturing organisations

The Person

The ideal candidate for the Manager of Analytical Development and Quality Control role:
* Has related pharmaceutical experience combined with relevant degree and working experience in analytical development
* Experienced in analytical development and/or quality control for parenteral products including sound understanding of microbial testing/monitoring.
* Experienced in late phase development activities
* Has experience with OOS and OOT investigations
* Has experience with Investigational New Drug, New Drug Applications and responding to CMC questions from FDA/international regulatory authorities.
* Has prior experience in the development of analytical methods for injectable products and medical devices.
* Has strong communication skills both in German and English (verbal and written), French is a plus

If you are interested in this role, please apply via this website. Alternatively, you can reach out to me via phone on +442072556630 or via LinkedIn www.linkedin.com/in/erdelyiakos.

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