Operations Specialist Pharmacology-Toxicology-Bioanalytics

We are looking for an additional colleague in our toxicology and bioanalytics team to complement our operations specialist to support bioanalysis, nonclinical and clinical activities. We look for somebody who takes pride in organizing the teams’ many tasks in an efficient and compliant manner and looks forward to tightly working with a colleague and the team. The title and level will be according to the level of experience of the incumbent.

Key Accountabilities/Responsibilities

He/she provides operational support to the team and in that role

• is responsible for keeping overviews of study documentation and archiving

• is the team training coordinator/backup and ensures that training curricula are kept updated by the team leaders

• is expert user of electronic documentation management systems (can act as business owner)

• helps the team with the development, review and update of procedural documents including analytical method protocols, standard operating procedures, working instructions and template documents.

• supports the team with managing documents in electronic systems throughout the document life cycle (including authoring, approval and archiving). Is the owner/backup of pre-defined document workflows in electronic systems

• performs guided Quality Control checks on critical datasets and regulatory documents

• assists in sample/specimen/document management in support of non-clinical safety and clinical studies

• supports shipments from and to bioanalytical vendors and nonclinical CROs

• assists with organizing internal and external activities (scheduling meetings, agenda, meeting minutes

Desired Skills And Experience

• Bachelor’s degree in a scientific discipline or equivalent through education and experience

• Quality-minded individual who is accurate in reporting and execution

• Fluent in English – our working language

• Proficient in standard software applications such as Outlook, Word, Excel and PowerPoint. Experience with document management systems e.g Veeva and Sharepoint is a plus

• Team player and good communication skills

• Flexible attitude, capable of picking up the tasks that require attention

• Experience in a similar position is a plus

• Experience in bioanalytical methods is a plus

• Knowledge of nonclinical safety is a plus

• Knowledge of GLP is a plus

Offer

• A competitive salary package with benefits

• A part-time position is possible

• A work environment in a human-sized, dynamic, rapidly growing biotech company