Supervisor, QC Chemistry

Summary

Location: Indianapolis, IN #LI-Onsite

About this role:

In this people management role, the QC Chemistry Supervisor works with the Quality Control team in supporting our efforts of RLT therapy. This role is responsible for the day-to-day oversight of the QC Chemistry team including raw material testing and final product testing.

About the Role

Key Responsibilities:

• Supervision of laboratory personnel.
• Provide oversight for personnel work schedules as well as for scheduling and completion of testing and documentation.
• Provides oversight towards QC laboratory equipment maintenance.
• Expertise in one or more of the following methodologies: HPLC/UPLC, wet chemistry, TLC, endotoxin, radionuclidic identity by half-life, environmental monitoring, sterility
• Maintain the laboratory and laboratory procedures/processes in a constant state of inspection readiness.
• Ensure personnel are appropriately trained and cross-trained.
• Author, review, and approve technical documents.
• Ensure trending reports are completed and approved within established timelines.
• Support 5S and Lean Laboratory implementation and sustainability.
• Provide support of laboratory related manufacturing investigations, CAPAs, and change controls.
• Ensure safety requirements are met and maintained.
• Perform other job duties as assigned.
• Design and execute method transfers/qualifications/validations based on Regulatory guidelines and industry best practices.
• Collaborate with other groups to drive project success.
• Troubleshoot method challenges.
• Manage method development and optimization activities as needed.

Essential Requirements:

• BS or MS in Biology, Chemistry, Microbiology or other related science.
• Minimum of 5 years of relevant experience in the pharmaceutical, biologics, medical device, or advanced therapy medicinal products industry.
• Previous supervisory experience is recommended but not required.
• Working knowledge of aseptic manufacturing, cGMPs, GLPs and applicable compendial and regulatory guidelines (e.g. FDA, EP, JP)
• Thorough knowledge of analytical and microbiological test methods.
• Experience with LIMS.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?