We are currently recruiting for a Lead Scientist to join our Immunochemistry department in Harrogate, which specializes in large molecule bioanalysis.
It is an exciting opportunity that will offer you the chance to become part of an exceptionally talented staff community that helps to bring the miracle of medicine to the market sooner.
The post holder should have a BSc, MSc/PhD or equivalent and have experience of managing regulated studies. A strong background of sponsor management in a CRO or pharmaceutical environment and experience with ligand binding technologies would also be advantageous.
Key Responsibilities and duties
- Serves as a Study Director, Responsible Scientist, or Principle Investigator for non-regulated, GLP-regulated, and GCP-regulated studies as applicable.
- Ensures client programs meet Covance, Sponsor, and regulatory requirements.
- Serves as the scientific point of contact for the Sponsor.
- Works with the Sponsor to determine project requirements.
- Develops and reviews protocols and sample analysis plans.
- Reviews data with the method development team to ensure methods are ready for validation.
- Approves validation methods and reviews sample analysis methods.
- Identifies scientific issues or scope changes within the study.
- Independently reviews and approves raw data.
- Reviews and approves reports for scientific accuracy and completeness.
- Takes accountability and demonstrates responsibility regarding scientific study conduct.
- Provides technical support as needed.
- Actively promotes collaboration within and across groups.
- Provides appropriate coaching and recognition to team members.
- Promotes a positive impression of Covance internally and within the industry.
- Plans, prioritizes, and manages workload for large and complex projects.
BSc, MSc/PhD or equivalent in science or related field.
- 3+ years of experience in the job discipline
- GLP/GCP study management
- Knowledge of regulatory agency guidelines
- Experience of ELISA, MSD® and Gyrolab® technologies preferred
- Experience of Watson® LIMS preferred
- Excellent communication and interpersonal skills
- Proven ability to prioritize and manage time
- Excellent attention to detail
- Able to utilize word processing, database, spreadsheet, and specialized software
By joining us you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world.