Scientist / Sr. Scientist – Upstream – Technical Services – Manufacturing Sciences Laboratory Full-time

Upstream Scientist – Technical Services/Manufacturing Sciences Laboratory

The TS/MS Upstream Scientist will provide direct technical support in the TS/MS laboratory. The successful applicant will have technical expertise in laboratory scale models for upstream operations and demonstrate strong data-driven decision-making and problem-solving capabilities. They will work to continuously improve process efficiency by implementing new technologies and process improvements in addition to investigation support. This role will incorporate the use of data analytics and process analytical technology to support the next generation bioprocessing facility in laboratory scale models to drive process development.

Key Responsibilities

• Have an in-depth knowledge of the science of biotech manufacturing and associated laboratory models and analytical tests, supporting upstream processing.
• Expertise in laboratory scale equipment operation and trouble shooting.
• Understand molecule-specific control strategy and basis of specifications and critical quality attributes.
• Work with the network and development organizations to ensure a well-understood, robust and fit-for-purpose laboratory models are developed and transferred. This will include those specific to the NGB processing including implementation of process analytical technologies in support of multivariate analyses and process modelling.
• Experience with the application of Raman spectroscopy integration into mammalian cell culture bioreactors
• Leading laboratory investigations in support of production operations.
• 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.
• 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.
• Understand basic statistical methodologies and statistically based experimental design.
• Identify process improvements and participate in implementation of Lean manufacturing initiatives
• Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies

Basic Requirements:

• PhD degree based in biology, chemistry, biochemistry or similar discipline. MSc or BSc with equivalent experience may also be considered.
• Experience (>2 yrs) working in pharmaceutical laboratory and GMP manufacturing environments.

Additional Requirements:

• Demonstrated technical capability with high productivity
• Proven track record of curiosity with learning agility
• 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
• Proficient in English

Work Environment:

• These are 8-hour day roles. As a manufacturing support function, the need for occasional evening or weekend support can arise.
• Although expected to be minimal, occasional travel is possible including to other Lilly sites both in- and outside of Ireland.