SEC Recruitment: Fill and Finish Operations Manager

I am seeking a Fill & Finish Operations Manager on behalf of an international Biopharmaceutical company in Switzerland.

This is an opportunity to participate in the long term development of the Technical Services of a Biotech site and build a team of upstream and downstream specialist in Production Support with a focus on Fill & Finish Operations, Lyophilisation and Tech Transfer.

If you are interested in this opportunity, please send your CV to Fabrice Akakpo at fabrice.akakpo@secpharma.com.

Main responsibilities

In this role you will be :

The owner of Process FMEA and support for gap remediation.
The Tech Transfer leader and responsible for process alignment between sites.
Responsible for the manufacturing support for investigation on process and raw materials.
Leading yield investigation and potency targeting owner.
Responsible for Process improvements (lyophilisation cycle reduction and one shot dilution).
Applying Quality By Design Process monitoring approach on Critical Quality Attribute and Critical Process Parameter.
Responsible for Supplier Notice change evaluation on raw materials.
Supporting alternate sourcing program.
Owner of Change Request, Non Conformity and CAPA on your field.
Determining Product Impact assessment related to manufacturing issues.

Requirements

Master or PhD in Biochemistry.
Extensive experience in a process development or technical support functions in pharma industry with a demonstrated experience in people management.
Good understanding of c-GMPs.
Technical knowledge of French and excellent communication in English.
Proven expertise in aseptic filing and lyophilisation operations
Proven problem solving.
Solution and results driven, ability to work in a cost effective way under tight deadlines, solid networker and team player.

To apply for this position, please send your CV to Fabrice Akakpo at fabrice.akakpo@secpharma.com and I will call you for a confidential conversation.

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