For one of its clients, a global specialty contract research (CRO) laboratory collaborating with the largest pharmaceutical and most prominent biotech companies, Kelly Science is currently recruiting a Scientific Project Lead.
Global Mission - The Project Lead:
- Leads method validation, assay transfer and sample analysis studies based on approved driving documents;
- Prepares and/or reviews experimental documentation for assigned studies;
- Prepares and/or fills associated documentation relevant to the studies as per appropriate SOP/CSP and applicable regulatory requirements;
- Writes and reviews method procedures (SOP/CSP);
- Is responsible for binder submission to QA and answering of QA audit reports.
Daily responsibilities - the Project Lead:
- Manages method validation, assay transfer and sample analysis studies;
- Prepares and/or reviews worksheets related to studies;
- Ensures personnel are trained and training appropriately documented;
- Ensures high level documents are signed and acknowledged by personnel involved in the study;
- Ensures study binders are up to date;
- Follows up on assigned study inventory, sample manifest and deviations;
- Follows up on QC review and ensures it is performed in a timely fashion;
- Prepares and/or reviews of data tabulation and study related documents;
- Works in collaboration with the Principal Scientists, the Research Assistants and the Research Associates ;
- Coordinates with the relevant transversal units (e.g. Data Analysis, QC, Sample Management, QA) to deliver quality data on time;
- Submits studies to QA and answers to QA reports;
- Schedules experiments based on the timelines, priorities and requirements;
- Writes and reviews method SOP/CSP;
- Is responsible for coaching, mentoring, training and day to day interaction with the Research Assistants and the Research Associates for assigned studies;
- Performs biobanking-related activities (sample reception, tracking and inventory) in compliance with applicable procedures;
The profile of the Project Lead:
- Master in Life Sciences or equivalent, preferably in Immunology, with a minimum of 2 years of experience in a similar position;
- Good knowledge of clinical study conduct;
- Good knowledge and understanding of bioanalytical method validation guidelines and requirements;
- Knowledge and understanding of GLP, GCLP regulations to carry out GLP studies;
- Knowledge of procedures and protocols for containment of biohazardous material, safety procedures and guidelines;
- Strong experience in working in a normative environment;
- Excellent level of French with strong writing skills in English (writing procedures and protocols);
- Strong cross-functional communication skills;
- Demonstrated time and priority management skills;
- Effective organizational skills and flexibility;
- A permanent contract in an innovative and dynamic CRO environment;
- A challenging position with plenty of responsibilities;
- A competitive salary package in line with your profile and experiences.
Regarding this role, Kelly Services acts as the official mediator. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement.
In keeping with the Law regarding discrimination and equal opportunity in Belgium, Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.
Met betrekking tot deze functie fungeert Kelly Services als officieel bemiddelaar. Wanneer je de beslissing maakt om op deze functie te solliciteren zullen jouw gegevens in overeenstemming met Kelly's Privacy Statement worden verwerkt.
Met oog op de wetgeving tegen discriminatie en het gelijke-kansenbeleid van kracht in België, verwelkomt Kelly Services sollicitaties van iedere geschikte kandidaat, ongeacht etniciteit, geslacht, beperking, religieuze overtuiging, seksuele geaardheid of leeftijd.
Concernant ce rôle, Kelly Services agit en tant que médiateur officiel. Lorsque vous décidez de postuler ce poste, vos informations personnelles seront traitées conformément à la déclaration de confidentialité de Kelly.
Conformément à la loi sur la discrimination et la politique d'égalité des chances en Belgique, Kelly Services accueille les candidatures de tous les candidats éligibles, quels que soient leur origine ethnique, leur sexe, leur handicap, leur religion, leur orientation sexuelle ou leur âge.