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Covance QC Scientist-Bio CMC/Bio-Distribution Studies in Greenfield, Indiana

Job Overview:

The ideal QC Scientist has demonstrated depth of expertise in multiple technical assays, supporting independent performance and troubleshooting of multiple technical assays. Incumbent has strong knowledge of the scientific principles underlying their assay responsibilities and broader the technical field. Drafts complex technical, laboratory and system SOPs that meet GLP requirements. Drafts and reviews methods, working documents, protocols and reports as required. Contributes support to laboratory operations outside of their specific technical area of responsibility.

  • The QC Scientist routinely manages a number of assays pertaining to common techniques; where necessary, guidance will be provided by a more experienced QC Scientist. Typically, the QC Scientist will be responsible for single projects (for one or several related techniques), maybe part of a larger cross-sectional team leading small to medium multi-technique projects, or be part of a larger cross-sectional project working in conjunction with a more experienced QC Scientist or Lead Scientist (LS).

  • Project requirement may include, but are not limited to: assay transfer, validation and sample analyses. They will write protocols and reports, prepare and review analytical procedures, and are accountable for the approval and integrity of data and associated quality documentation.

  • The QC Scientist has knowledge within a relevant field and is able to troubleshoot techniques in their area of their expertise. The management and approval of assay data by the QC Scientist forms a large area of responsibility for GLP projects. They may also be required to act as a Study Director (SD) or Principal Investigator (PI) for GLP projects, or Responsible Scientist (RS) for GCP projects. The QC Scientist is therefore required to adapt to changing regulatory requirements, depending on project types.

  • In this role, the QC Scientist will provide internal customers with a central scientific point of contact for techniques within their area of expertise, or for external Clients where the QC Scientist is not the scientific lead. The individual is accountable for effective communication directly with the Client to ensure that Client requirements and project deliverables are met. This includes discussion with the Project Management Office (PMO) and communication with managers as well as other scientific an analytical staff. The QC Scientist has scientific oversight of relevant techniques in order to ensure the successful initiation, planning, execution, monitoring and completion of projects.

  • The QC Scientist is required to have good working knowledge of the GLP/GCP and regulatory guidelines as they ensure that projects are carried out to the required standards, and that work is conducted in compliance with applicable regulatory requirements.

  • The individual will work with more experienced QC Scientists to identify and communicate scientific and regulatory developments within their field of expertise, to include QA, management and laboratory analysts. The QC Scientist may represent Covance internally or externally by preparing and/or giving presentation, writing or supporting the preparation of scientific papers and/or posters, in order to communicate the work of Covance laboratory operations.

  • 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 operations team.

  • The individual will adhere to all applicable SOP’s and will be responsible for completion of all relevant documentation.

  • ESSENTIAL JOB DUTIES:

  • With appropriate levels of support, apply critical thinking and application of knowledge to discuss techniques/procedures within team and externally (e.g. during cross training, with clients and during QA inspections)

  • Draft answers to study related audit comments

  • Actively participate in client discussions around technical aspects of studies

  • Through active mentoring, learn to:

  • Manage more complex client requirements to rapidly on board new client projects

  • Design standard protocols

  • Perform scientific review and approval of complex study reports and analytical data

  • Be a credible resource for scientific escalation of analytical techniques

  • Through active mentoring, gain confidence leading scientific discussions with the client

  • Document work and maintain study documentation and laboratory records.

  • Recognizes deviations from expected results and recommends appropriate action.

  • Plans and implements method development projects and studies in compliance with appropriate SOPS and regulatory guidelines. Develops, modifies, validates, and performs

  • methodology for routine and/or non-routine analyses.

  • Identifies and takes appropriate action with problems or potential problems with multiple technical assays in technical area of responsibility.

  • Ability to develop and implement an action plan for solving project or technical problems as they occur.

  • Support the implementation of startup priorities, systems and SOPs for the Biodistribution group.

  • Promotes a cohesive team environment.

  • Leads project meetings - Plans, monitors and guides the project work.

  • Lead and develop others in the duties to ensure study related activities are completed on time by:

  • Leading effective and concise communication and lead study start up meetings and ongoing study meetings with team members

  • Have the ability to listen and discuss ideas in an open and professional manner

  • Support resolution of escalated operational issues

  • Able to communicate project/study specific requirements to ensure understanding by all team members

  • Provide constructive feedback

  • Independently reviews scientific content accuracy and study validity in protocols and reports prior to Sponsor review

  • Write, revise, and review complex, technical SOPs and methods for compliance with regulatory guidelines.

  • Trains and may oversee less-experienced staff in aspects of operation of area of technical responsibility.

  • Participates in client visits as needed, assists in communicating technical information.

  • Able to review work of others for overall accuracy, timeliness, completeness, and soundness of technical judgment.

  • Assists in evaluation of data for incorporation into written reports.

  • Participates in process improvement initiatives.

Education/Qualifications:

  • BS/BA degree in science or related field

  • Graduate degree strongly preferred

  • Strong ability to learn is required

  • Demonstrates excellent oral and written communication skills

  • Strong interpersonal skills

  • Organizational skills

  • Experience:

  • 3+ years of experience in the biotechnology, biopharmaceutical or pharmaceutical industry

  • 6+ years of scientific experience relevant to the technical area of responsibility

  • Broad based technical experience and demonstrated ability to learn is required

  • Experience with equipment and analysis related to technical area of responsibility is required

  • Experience in a high throughput regulated environment strongly preferred

  • GLP compliance experience preferred

  • Experience with laboratory-related computer systems is preferred

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

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