Bioanalytical Scientific Manager (multiple global locations) in Windsor - UCB Group

Job Overview

Location
Windsor, Northern Ireland
Job Type
Full Time
Salary
TBC
Date Posted
3 days ago

Additional Details

Job ID
43001801
Job Views
1

Job Description

Make your mark for patients. We’re here because we want to build the future and transform patients’ lives for the better.At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?To strengthen the Translational Biomarker & Bioanalytics group, we are looking for a talented individual to fill the position of Associate Director/Principal Scientist.For this position we can be flexible on the following locations; Braine l’Alleud- Belgium, Slough - UK, Boston - USA, Monheim - Germany, Shanghai - China or Geneva - Switzerland.You like to work in an environment where you can:Be accountable for the design of the bioanalytical strategy and the execution thereof (Pharmacokinetic, Immunogenicity and Biomarker)Assures bioanalytical tasks are executed with good scientific quality, in line with regulatory expectations and appropriate quality system, and within the agreed upon timelines. This entails overseeing the execution by internal facilities or external vendors.Act as departmental representative in multidisciplinary project teams.Ensures effective utilization of study budgets associated with Bioanalytical strategy. (e.g.  method development and validation (50-100k per study), clinical trials (100k - ( 1M)You will contribute by:Being accountable for the design of the bioanalytical strategy and the execution thereofPK, ADA, « wet » biomarkersFrom DP3/4 on: toxicology studies, clinical studies and post-marketingWorks together with stakeholders (TM lead, QCP, safety rep,…) to translate project and study goals in a bioanalytical strategyWork with stakeholder to establish a robust, scientifically valid biomarker strategyAssures bioanalytical tasks are executed with good scientific quality, in line with regulatory expectations and appropriate quality system, and within the agreed upon timelines. This entails overseeing the execution by internal facilities or external vendors. Capable of handling multiple projects and/or complex projects (with multiple bioanalytical endpoints);Responsible for oversight of internal and external laboratory based activitiesEstablish strategic plan to mitigate risk and resolve technical issues as they ariseEnsures effective utilization of study budget associated with Bioanalytical strategyIs an expert in one or more bioanalytical techniques and methods (NCE PK methods, LBA, Flow cytometry, Immunogenicity assays, targeted protein LC-MS/MS).Provide leadership across UCB on key areas of expertiseAct as a strategic advisor or mentor for junior colleagues.Participates in preclinical study design and documentation, and in clinical study design and documentation (lab manual, protocol, SAP,…).Responsible for writing the bioanalytical sections of regulatory documents (IB, IND, scientific advice). Contributes to the regulatory strategy and provide bioanalytical expertise during meeting with regulatory authorities (EMA, PMDA, FDA).Participates in scientific advice meetings when appropriate.Responsible for quality of all PK, Immunogenicity and biomarker data for programs under his/ her controlDirectly manages the Immunogenicity Risk Assessment activities as well as ensures all documentation is in places and key stakeholders are engagedAct as a departmental representative for multidisciplinary project teams. Communicate proactively to different stakeholders. Communicate effectively and efficiently to department.Take actions when deliverables are at risk for being met.Has an impact on the project strategy.Maintains and utilizes up to date expert knowledge gained from scientific publications and competitor information.Capable of assessing gaps within and across programs and lead the implementation of novel work practices that go beyond core bioanalytical activitiesImplement new strategic initiatives across UCB including the ability to guide others through change.Interested? For this position you’ll need the following education, experience and skills:Experienced in regulated bioanalysis in support of clinical and pre-clinical trials for the development of Biologics.Experienced in development, validation and application of Large Molecule assays.Represent UCB at external meetings including contributions at meetings by way of presentations, scientific committee representation and publications.Participates in vendor governance through technical and study audits.Compliant towards the adequate quality systems (GLP, GcLP, GCP).Knowledge of regulatory compliance and validation requirements (GLP, GCLP and FDA and EMA Guidelines) for Immunoassays, Enzyme and Flow Cytometry assays.Specialized in Pharmacokinetics (PK), Immunogenicity (ADA) and safety, exploratory and efficacy Biomarkers.Knowledge of emerging technology platforms (e.g. ultra-sensitive assays).Recognized as an expert in their specific area of expertise and with a proven track record influencing the external scientific or regulatory community.Work with internal and external stakeholders to develop novel solutions to support the portfolio.Experience in working with technical staff to ensure assays are developed and fit for purpose to support the biologics portfolio.Work with different external (e.g. CRO, academic) and internal (DMPK, Research) partners in a matrix environment to ensure timelines and deliverables are clearly communicated.Ability to understand key partner and stakeholder requirements and design experiments appropriately.Design experiments for the CRO partners to enable the timely development/validation of assays to deliver for the portfolio.Evaluate data and provide next steps.Critical review of study data and providing interpretation to study teams.Evaluate new technology platforms (e.g. by literature review, attending webinars, visiting vendors at conferences).Excellent at defining, analyzing and solving problems.Using sound judgment to make good decisions based on information gathered and analyzed.InternalCollaborate with the Bioanalytical Laboratory.Work with internal partners in different functional areas (e.g. Non-Clinical Safety, DMPK, Clinical Pharmacologists, Translational Medicine, Clinical Operations and Quality Assurance) and influence team decisions.Work with colleagues both in Braine and Slough.ExternalManage outsourced studies at CROs and at academic sites.About us.UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science. At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.  Curious to know more? Please visit our website .UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.Job SummaryJob number: 81406Date posted : 2022-07-01Profession: Research & DevelopmentEmployment type: Permanent

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