Sr. Principal Lab Scientist

About the role

The TS/MS Senior Principal Scientist will provide direct technical support for the design, startup and execution of the TS/MS laboratory. This role will provide technical expertise for the laboratory startup activities including facility design, instrument procurement and qualification in support upstream and downstream operations as well as analytical instrumentation. This role will serve as a technical leader and mentor to laboratory scientists and will be integral in defining the laboratory's technical agenda.

Responsibilities

• Have an in-depth knowledge of biological manufacturing, laboratory-scale models and analytical methods, supporting both upstream and downstream processing.
• Work with the network and development organizations to ensure a well-understood, robust and fit-for-purpose laboratory models are developed and transferred.
• Support the design and start-up of the laboratory including equipment configuration and purchase, development of the laboratory data management strategy, establishment of laboratory protocols.
• Support a laboratory startup plan in alignment with the health, safety and environmental team to ensure safe startup and operation.
• Experience in laboratory scale equipment operation and trouble shooting.
• Supporting the development and mentorship of other laboratory scientists in alignment with area management.
• Create and review documents including laboratory SOPs, material specifications, protocols, and work instructions.
• Establish partnerships to enable cross functional work with the quality control laboratory and other Lilly sites to ensure facility startup objectives are met.
• Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies.

Requirements

• BS degree based in biology, chemistry, biochemistry or similar discipline.
• Experience (>5 yrs) working in pharmaceutical laboratory and GMP manufacturing environments, and/or managing an academic lab.

Qualifications

• MS or PhD degree based in biology, chemistry, biochemistry or similar discipline.
• Ability to provide technical leadership in a laboratory setting with experience in upstream and downstream processing, and analytical testing.
• Demonstrated technical capability with high productivity.
• Self-starter with high initiative and data-driven approach to problem-solving.
• Demonstrated strong interpersonal skills.
• Demonstrated strong verbal and written communication skills.
• Demonstrated adaptability and flexibility to working in different environments, teams etc.
• Demonstrated ability to participate in and facilitate decision-making.