QC Scientist - Bioassay

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong><span style="color: windowtext;">Do you have experience of Client Study Management and looking for your next opportunity to join an expanding team?</span></strong></span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong><span style="color: windowtext;"> </span></strong></span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong><span style="color: windowtext;">Are you interested in career development opportunities with management responsibility?</span></strong></span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; color: windowtext; font-size: 12pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong><span style="color: windowtext;">Do you want to be a part of the world's leading drug development company?</span></strong></span></p><p style="margin-right: 1.8pt;"> </p><p style="margin-bottom: .0001pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></p><p style="margin-bottom: .0001pt;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Labcorp Drug Development</strong> 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. </span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><em> </em></span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>What Labcorp Drug Development can offer you:</strong></span></p><ul><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Competitive salaries and a comprehensive benefits package including health cover and contributory pension</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Unrivalled opportunities to develop a successful career in the scientific industry, utilizing multiple analytical techniques</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Unsurpassed career development opportunities, with the ability to develop your management skills</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to work with a variety of different clients on wide ranging projects</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Opportunity to work in a rapidly expanding and leading edge field</span></li></ul><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Job responsibilities include:</strong></span></p><p style="margin: 0px;"> </p><ul><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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 conclusions</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Working 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 necessary</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assist in the preparation/review of training modules in areas of expertise and mentors and develops others in the group </span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">In-depth knowledge of study process from award to <span style="font-size: 12pt; font-family: Arial, sans-serif; color: #000000;">finalisation </span>archiving and amendments to final reports and to write and review Analytical Procedures, Policies, SOPs and Guides where appropriate.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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 Development</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Participate in client regulatory audits and perform revenue recognition where required</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsible for on-time delivery of data, project documents, and quality documents</span></li></ul><p style="margin: 0px;"><span style="text-decoration: underline;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Relocation assistance may be available for this role</strong></span></span></p><p style="margin: 0px;"> </p><ul><li><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Join a supportive, diverse community of hard-working people who push new boundaries</span></strong></li></ul><ul><li><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Expand your expertise and open the door to many advancement opportunities within our global organization</span></strong></li></ul><ul><li><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">G</span></strong><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">et ready to transform healthcare and change lives around the world</span></strong></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 12.0pt;">The post holder should ideally have a relevant degree/PhD and extensive industry experience within </span><span style="font-size: 12.0pt;">CMC Drug Development</span></span></li></ul><h2>Experience:</h2><p style="margin: 0px;"> </p><ul><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience will have been gained in similar types of study management (either internal or external) and experience of Client management</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Technical expertise in an appropriate scientific discipline<span style="background-color: #ffffff;"> and </span>working knowledge of a wide range of CMC analytical techniques  eg: <span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; background-color: #ffffff;"><strong>HPLC, ELISA, cell based assays or C<span style="font-size: 12pt; font-family: Arial, sans-serif; background-color: #ffffff;">apillary Electrophoresis and compendial techniques </span></strong><span style="font-size: 12pt; font-family: Arial, sans-serif; background-color: #ffffff;">and an</span></span></span><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"> up to date knowledge of regulatory guidelines</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Commercial awareness, interpersonal and negotiating skills</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Learn and maintain knowledge of process excellence processes, tools and activities</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Working knowledge of statistics and its application to techniques and regulatory applications (validation, equivalence)</span></li><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">An in-depth knowledge of health and safety policies, Company policies and procedures, and an in-depth understanding of GMP/GLP/GCP</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.</span></li></ul>