MENU
Back
Belgium Keyrus Life Science

Bioanalytical Scientific Manager

Job Description

  • 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

Profile

  • 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

You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.

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

Category

Biostatistics

Location

Walloon Brabant

Contact person

de Meester