QC Study Director - Molecular Biology

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Job description

Job Overview:Do you have experience of Client Study Management and looking for your next opportunity to join a rapidly expanding team?Are you interested in developing your career with management responsibility?Do you want to be a part of the world's leading drug development company?Our largest UK site in Harrogate, North Yorkshire is currently recruiting for a QC Scientist/Study Manager/Director to join the CMC (Chemistry, Manufacturing Controls) division and will be responsible for the managing of batch testing, release testing, sample analysis, stability, assay development, assay establishment or validation/transfers with monoclonal antibodies. This role is looking for previous experience with qPCR and DNA extraction to work with the Microbiology/ Gene Therapy teams.Labcorp Drug Devlopment has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. Chances are, you or someone you know has benefitted from a medicine or medical device that Labcorp Drug Development helped develop.What Labcorp Drug Development can offer you:Competitive salaries and a comprehensive benefits package including health cover and contributory pensionUnrivalled opportunities to develop a successful career in the scientific industry, utilizing multiple analytical techniquesUnsurpassed career development opportunities, with the ability to develop your management skillsAbility to work with a variety of different clients on wide ranging projectsOpportunity to work in a rapidly expanding and leading edge fieldJob responsibilities include:Act as a Subject Matter Expert (SME) or Principal Investigator within BioCMC with knowledge of standard and non-standard study designs and the ability to draw scientific conclusionsWorking method knowledge e.g. instruments used within the laboratories and ability to make decisions on assay results, suggest assay/technique advancements/improvements to the client, and follow through with the client as necessaryAssist in the preparation/review of training modules in areas of expertise and mentors and develops others in the groupIn-depth knowledge of study process from award to finalisation archiving and amendments to final reports and to write and review Analytical Procedures, Policies, SOPs and Guides where appropriate.Employ effective general management, communication and interpersonal skills to work within the project teams, with the Client and other project stake-holders e.g. supporting functions at Labcorp Drug DevelopmentParticipate in client regulatory audits and perform revenue recognition where requiredResponsible for on-time delivery of data, project documents, and quality documentsRelocation assistance may be available for this roleJoin a supportive, diverse community of hard-working people who push new boundariesExpand your expertise and open the door to many advancement opportunities within our global organizationGet ready to transform healthcare and change lives around the worldEducation/Qualifications:The post holder should ideally have a relevant degree along with industry experienceExperience:Technical expertise in at least one of the following scientific disciplines - eg qPCR, DNA extraction within Microbiology or Gene TherapyExperience in similar types of study management and client managementAn in-depth understanding of health and safety policies and a good understanding of GMP/GLP/GCP and an up to date knowledge of regulatory guidelinesAble to communicate effectively at all levels with internal employees and external clients, with the ability to get things done by influencing othersCommercial awareness, interpersonal and negotiating skills and able to learn and maintain knowledge of process excellence processesCommercial awareness, interpersonal and negotiating skills