Quality Control Senior Scientist

WuXi AppTec
CH - Nebraska - / /CH
December 31, 2024

The Senior Scientist is part of the the Quality Control (QC) department of STA Pharmaceuticals Switzerland. The Team is responsible for introducing new raw materials, drug substance (API), and drug product (Bulk) as well as new technologies at the site. The Senior Scientist provides technical and scientific expertise to support transfer/verification/validation of new methods and investigation and troubleshooting of analytical issues (commercial or not). Additional duties includes participating to registration stability studies, participating to supplier qualification & supplier Audit, participating to cleaning validation and validation processes, and leading QC risk assessments.

The Senior Scientist assists other technical support team members with questions and technical issues and acts as a point of contact in absence of the Manager. He/she plays an expert role and shares know-how with colleagues regarding methods, deviation, CAPA, Change control and QC processes. As a Senior QC Team Member, this position acts as a center of competences reflecting experience, transferring knowledge and support other team members in all aspects of their daily work.

This position is located at STA Pharmaceuticals Switzerland site in Couvet.

A. Is responsible for introducing new methods (Raw Materials, APIs and Drug products)

Evaluates method clients and identify blocking points
Performs or support feasibility experimental work as needed
Manages of the transfer/verification/validation protocols and reports
Implements methods
Manages the methods/specification documentation
Implements cleaning methods and participates to cleaning validation

B. Is responsible for introducing new technologies:

Works cross-functionally with QC support, the commercial team, QA, IT and other departments to select, purchase and qualify new technologies for the QC laboratory
Performs feasibility experimental work as needed

C. Uses scientific and technical expertise to investigate and resolve technical issues in the laboratory (for all that needs scientifical and technical expertise when appropriate (QC complaints included)).

Owns deviations, leads or supports laboratory investigations
Can approve laboratory investigation checklists
Provides guidance for confirmatory testing
Writes or reviews investigative testing plans or retest plans prior to execution
Defines corrective and preventive actions (CAPA)
Can approve laboratory investigations and deviations as SME/Area Manager

D. Represents AS&T in project teams

Represents AS&T in cross-functional project teams, interacting with Project Management Office, Manufacturing, QC Technical Support, QC commercial
Leads or supports risk assessments, owns change controls
Manages method transfer plans. Performs or supports feasibility experimental work as needed. Manages or support method transfer, method verification and method validation activities.

E. Maintains the GMP status of the laboratory and analytical methods.

Performs all activities in compliance to cGMP requirements as well as to EHS rules and safe work practices per applicable procedures.
Evaluates impact of compendial changes on applicable QC procedures and opens change controls as required.
Performs other tasks as assigned

F. Acts as a Center of Competences and acts as a delegate of AS&T Manager

Provides technical guidance, training and support to peers.
Review and approve all documents generated by other team members
Is a central point of contact in manager's absence
Communicates effectively with management regarding more complex issues.
Assist with capacity forecasts and allocation of resources
Conduct effective training of QC personal (QC analysts, QC scientists)
Actively participates in inspections by health authorities and corresponding preparation
Performs other tasks as assigned.

Read the full job description and apply online on the recuiter's web-site

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