Study Lead-QC Scientist III-BioPharm CMC

<h2≥Job Overview:</h2≥<p style="margin-top: 6.0pt;"≥<strong≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥Working as part of the QC Laboratory Operations Group, independently, the QC Scientist will manage small to large, multi-technique projects (as a molecule lead) and provide internal and external Clients with a central scientific point of contact for projects within BioPharmaceutical CMC Solutions (BioPharmCMC). <span style="color: black;"≥The individual is accountable for </span≥effective communication with the Client and <span style="color: black;"≥for leading the scientific teams to ensure that Client requirements and deliverables are met; working with the PMO, QC section managers as well as other</span≥ scientific and analytical staff to ensure the successful initiation, planning, execution, monitoring and completion of projects. </span≥</strong≥</p≥<ul≥<li≥<span style="font-family: 'times new roman', times;"≥<span style="font-size: 12.0pt;"≥Project requirements may include, but are not limited to; assay transfer, validation, sample analysis, batch/release testing, and stability studies. They will write protocols and reports, </span≥<span style="font-size: 12.0pt;"≥prepare and review analytical procedures, and be accountable for the approval and integrity of data and associated quality documentation. </span≥</span≥</li≥<li≥<span style="font-family: 'times new roman', times;"≥<span style="font-size: 12.0pt;"≥This role will be expected to routinely manage a number of assays pertaining to common techniques acting as both SME and molecule lead. <span style="color: black;"≥The management and approval of assay data by the QC Scientist forms a large area of responsibility for GMP projects, as they are</span≥</span≥<span style="font-size: 12.0pt;"≥ accountable for the approval and integrity of data, reporting and assigned associated quality documentation.</span≥</span≥</li≥</ul≥<p style="margin-top: 6.0pt;"≥<strong≥<span style="font-family: 'times new roman', times;"≥<em≥<span style="font-size: 12.0pt;"≥Additionally this role may focus as a molecule lead on more complex study types, executing a number of tasks identified below in support of molecule management:</span≥</em≥</span≥</strong≥</p≥<ul≥<li≥<strong≥<span style="font-family: 'times new roman', times;"≥<em≥<span style="font-size: 12.0pt;"≥Navigate the regulatory framework to ensure that the client programs are conducted to meet the defined milestones along the drug development pathway with scientific integrity.</span≥</em≥</span≥</strong≥</li≥<li≥<strong≥<span style="font-family: 'times new roman', times;"≥<em≥<span style="font-size: 12.0pt;"≥Communicate with internal and external project teams, departmental management and the Client to ensure effective scientific progress throughout the life cycle of a project in partnership with the PMO. </span≥</em≥</span≥</strong≥</li≥<li≥<strong≥<span style="font-family: 'times new roman', times;"≥<em≥<span style="font-size: 12.0pt;"≥Identify and communicate scientific and regulatory developments to QC operations and the wider senior scientific group (e.g Method Development/Clients). </span≥</em≥</span≥</strong≥</li≥<li≥<strong≥<span style="font-family: 'times new roman', times;"≥<em≥<span style="font-size: 12.0pt;"≥There is an expectation that the QC Scientists will be required to travel to visit clients and attend conferences, and represent Covance by preparing and/or giving presentations and writing scientific papers.</span≥</em≥</span≥</strong≥</li≥</ul≥<p style="margin: 0px;"≥ </p≥<ul≥<li≥<span style="font-family: 'times new roman', times;"≥<span style="font-size: 12.0pt;"≥The QC Scientist is expected to have a working knowledge of all methodologies for a Client project. They will write protocols and reports using approved data that fulfils the protocol design and all regulatory expectations.</span≥<span style="font-size: 12.0pt;"≥ In addition, they may be expected to prepare and review analytical procedures. </span≥</span≥</li≥<li≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥Project requirements may include, but are not limited to; (complex) assay transfer, validation, samples analysis, batch/release testing, and stability studies. </span≥</li≥<li≥<span style="font-family: 'times new roman', times;"≥<span style="font-size: 12.0pt;"≥The QC Scientist has knowledge within a </span≥<span style="font-size: 12.0pt;"≥relevant field and is able to troubleshoot techniques in the area of their expertise. They may also be required to act as a Study Director or Principal Investigator for GLP projects, or Responsible Scientist for GCP projects. The QC Scientist is therefore required to adapt to changing regulatory requirements, depending on project types.  </span≥</span≥</li≥<li≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥The QC Scientist is required to have in-depth knowledge of the GMP/GLP/GCP and regulatory guidelines as they ensure that projects are carrried out to the required standards, and that work is conducted in compliance with applicable regulatory requirements. </span≥</li≥<li≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥The QC Scientist will be responsible for overseeing the work of other QC Scientists where appropriate. They will be expected to train, coach and mentor members of the team and across functions as required. </span≥</li≥<li≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥The individual will identify and communicate scientific and regulatory developments within their field of expertise, to include QA, Management, Lead Scientists, QC Scientists and Laboratory Analysts. The QC Scientist will represent Covance internally or externally by preparing and/or giving presentations, writing or supporting the preparation of scientific papers and/or posters, in order to communicate the work of Covance QC laboratory operations. </span≥</li≥<li≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥The QC Scientist will be required to perform lab work as required, and provide support with regards to general laboratory operations and processes, leading by example to members of the QC operations team.</span≥</li≥<li≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥The post holder will adhere to the BioPharmCMC SOPs and will be responsible for completion of all relevant documentation.</span≥</li≥</ul≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥***RELOCATION PROVIDED***</span≥</p≥<h2≥Education/Qualifications:</h2≥<ul≥<li≥<span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"≥The post holder should ideally have a relevant degree and 6-8 years industry experience</span≥<span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"≥/PhD and at least 3 years relevant industry experience in CMC Drug Development.</span≥</li≥</ul≥<h2≥Experience:</h2≥<ul≥<li style="margin-left: .25in;"≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-family: 'times new roman', times; 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: 'times new roman', times;"≥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≥<li style="margin-left: .25in;"≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥Experience will have been gained in similar types of study management (either internal or external).</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥Experience of Client management</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥Technical expertise in an appropriate scientific discipline</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥An up to date knowledge of regulatory guidelines. </span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥Knowledge of capabilities and expertise of the Covance organisation and companies that may provide support services.</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥Commercial awareness, interpersonal and negotiating skills.</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥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: 'times new roman', times;"≥A working knowledge of a wide range of CMC analytical techniques</span≥</li≥</ul≥<p style="margin: 0px;"≥<span style="font-size: 12pt; font-family: 'times new roman', times;"≥Working knowledge of statistics and its application to techniques and regulatory applications (validation, equivalence)</span≥</p≥