Covance QC Scientist-Bio CMC/Bio-Distribution Studies in Greenfield, Indiana
A QC Scientist for Biopharm CMC, Biodistribution, has a demonstrated depth of expertise in molecular biology and the ability to support independent performance and troubleshooting of various DNA/RNA extraction techniques and various qPCR and RT-qPCR Responsibilities would include but not be limited to, analyzing and reviewing study data and methods, and drafting protocols and reports that meet GLP/GCP requirements. QC Scientists will be required to act as a Principal Investigator (PI) for GLP projects, or Responsible Scientist (RS) for GCP 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. Typically, the QC Scientist will be responsible for single projects (for one or several related techniques), may be 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). The role is accountable for the approval and integrity of data and associated quality documentation and provides scientific support and direction to laboratory operations.
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 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 and 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.
ESSENTIAL JOB DUTIES:
Design standard protocols
Independently reviews scientific content accuracy and study validity in protocols and reports prior to Client review
Draft answers to study related audit comments
Perform scientific review and approval of study reports and analytical data
Be a credible resource for scientific escalation of analytical techniques
Recognizes deviations from expected results and recommends appropriate action.
Able to identify and implement an action plan for solving project or technical problems as they occur.
Able to review work of others for overall accuracy, timeliness, completeness, and soundness of technical judgment.
Support resolution of escalated operational issues
Lead effective and concise communication and lead internal study start up meetings and ongoing study meetings with team members
Through active mentoring, gain confidence leading scientific discussions with the client
Actively participate in client discussions around technical aspects of studies
Able to communicate project/study specific requirements to ensure understanding by all team members Promotes a cohesive team environment.
Have the ability to listen and discuss ideas in an open and professional manner
Provide constructive feedback
Participates in process improvement initiatives.
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
3+ years of experience in the molecular biology, 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 or GCP 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.