Associate Director, Scientific Leader Assay Development Innovation > Wavre > Joboolo BE :
Société : 1849 GlaxoSmithKline Biologicals S.A. Lieu : Wavre Wallonia Site source : Talent BE
Lead an in/house lab team working on assaydevelopment and validation, performing early-stage development clinical testing.
Alternatively, lead the scientific oversight of assaydevelopment, validation and clinical testing performed at third party on behalf of GSK. Act as assay owner:
Ensuring assay performance fits its intended use by writing and reviewing the assay target profile.Being principal author and controlling assaydevelopment, assay qualification reports and assay validation plans in agreement with quality by design principles and fulfill requirements from regulatory authorities.
Write and review regularly assay summaries and procedures (SOPs).Being principal author of regulatory documents related to clinical laboratory assaysDeveloping and controlling the assay maintenance and monitoring plansDeveloping and controlling qualification critical reagent plansTransferring assay inside/outside of GSKPerforming assay troubleshooting and controlled assay continuous improvementWriting publications on his/her assay when appropriateManage a team:
Apply people management processes according to local rules (e.g.
people development, engagement, hiring, training, certification)Oversee team delivery, performance, and qualityDevelop and maintain the expertise in multiple assay technologies, support the continuous improvement and innovationPerform individual risk assessment for lab technicians and ensure lab activities are performed in agreement to EHS requirement and quality requirement (certification)Provide short to mid-term views on the anticipated workload versus capacities of the team, co-ordinate resources according to defined project priorities and CLAP/R&D initiativesEnsure all activities under responsibility are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations and internal policies.Provide support to the VxCLAP CRTLs:
For the definition of the assay target profile in agreement with the assay intended use in clinical endpointsfor the development of documents for INDs, regulatory submissions, response to questions from regulatory authorities during submission, inspectionsfor the review of the study design and protocol and discussion of study dataEnsure assay milestones are appropriately planed and communicated to project stakeholders at Project-related CONSO team.
Ensure oversight and encoding of activities, resources, and budgets in finance management tools.Act as spokesperson as the AssayScientific Expert on behalf of the CLAP organization to internal and external stakeholders (ie.
Communication to outsourcing committee, Preclinical teams, collaboration with academic partners, Key Opinion Leader ..
.
).Supervise continuous improvements of clinical laboratory processes, introduction of state-of-the-art methodologies, innovative solutions, and cross-functional team efforts.Participate to VxCLAP and R&D knowledge management in the field of expertise:
Provide support related to scientific and technical aspects of the assays to vaccine development/acquisition due diligence, Innovation Project Team.
Provide support for the development and/or review of internal and external publications, documents, and communications.Provide scientific coaching to lab managers and other CLAP members.Participate in the follow up of collaborations with other teams/experts to share/gain scientific and technical expertise and for technology transfer inside (i.e.
Preclinical, QC) and outside GSK Vaccines.Basic Qualifications:
University degree in Science, pharmacy, or other relevant discipline5 years experience in assaydevelopmentGood Quality cultureStrong immunology background, experience with respiratory viruses, scientific expertise in Biology and technology including automation.Communication across all organizational levels is required.
Ability to communicate issues, risks, data, and make decisions.
Equally important is the ability to lead within a large matrix international organizationProficiency in English, written and spokenPreferred qualifications:
you PhD in Science or PharmacyGood experience in statistics is an advantageProficiency in French, written and spoken#Li-GSKIf you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.Why Us?GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive.
We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.
We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK.
In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. 1849GlaxoSmithKlineBiologicalsS.A. WavreWallonia
