Bioanalytical Scientific Manager
Interact with bioanalytical project representatives to execute the bioanalytical strategy, including method transfer/validation and bioanalysis (small molecule PK) at key strategic vendors.
Assures bioanalytical tasks are executed with good scientific quality, within the adequate quality system, and within the agreed upon timelines.
Collaborate with multiple internal and external stakeholders to execute the bioanalytical strategy
Participate in clinical study design and documentation (lab manual, protocol, SAP,…)
Participate in harmonization of bioanalytical testing and reporting processes
- Experience in the pharma or CRO industry supporting regulatory bioanalysis of small molecules
- Knowledge of LC-MS based method for small molecule quantification
Knowledge of the latest regulatory standards required for GXP studies including international guidance’s published by regulatory agencies such as FDA, EMA
Previous experience managing contract research organizations
What we offer
Who we are
Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park Waterloo - Drève Richelle 161 - 1410 Waterloo
- Nijverheidslaan 3, - Strombeek-Bever