GCP Bioanalysis Principal Scientist

At Novartis, we are seeking a highly skilled and dedicated GCP Bioanalysis Principal Scientist to join our dynamic team. As a global leader in the pharmaceutical industry, we are committed to developing innovative therapies that improve and extend patients' lives. In this role, you will play a crucial role in ensuring the quality and compliance of our bioanalytical studies conducted under Good Clinical Practice (GCP) guidelines. We are looking for a talented individual with a strong scientific background, exceptional leadership skills, and a passion for driving excellence in bioanalysis. If you are a driven and collaborative individual with a strong commitment to quality, we invite you to apply for this exciting opportunity.

1. Develop and maintain expertise in Good Clinical Practice (GCP) guidelines and ensure that all bioanalytical studies adhere to these guidelines.
2. Lead and oversee all aspects of bioanalytical method development, validation, and sample analysis.
3. Ensure that all bioanalytical data is accurately and reliably generated, documented, and reported.
4. Collaborate with cross-functional teams to design and execute bioanalytical studies to support drug development programs.
5. Provide scientific and technical guidance to junior scientists and support staff.
6. Review and approve study protocols, reports, and other relevant documentation.
7. Identify and implement process improvements to enhance the efficiency and quality of bioanalytical studies.
8. Monitor industry trends and regulatory updates related to bioanalysis and make recommendations for process improvements to ensure compliance.
9. Participate in regulatory inspections and audits related to bioanalytical studies.
10. Communicate bioanalysis data and results to internal and external stakeholders in a clear and concise manner.
11. Contribute to the development of new assays and technologies to improve the quality and efficiency of bioanalytical studies.
12. Collaborate with external partners, including CROs and academic institutions, to support bioanalytical studies.
13. Ensure compliance with Novartis policies and procedures, as well as applicable laws and regulations.
14. Represent the company at scientific conferences and meetings, as needed.
15. Continuously evaluate and implement new technologies and methodologies to improve bioanalytical capabilities and processes.

According to JobzMall, the average salary range for a GCP Bioanalysis Principal Scientist in Cambridge, MA, USA is $130,000 to $180,000 per year. However, this can vary depending on factors such as experience, education, and the specific company or organization. Some individuals in this role may make more or less than this range. It is important to research the specific company and their salary offerings to get a more accurate understanding of potential earnings.

Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers surgical, ophthalmic pharmaceuticals, and vision care products. The Sandoz segment provides generic pharmaceuticals. The Vaccines & Diagnostics segment provides human vaccines and blood testing diagnostics.