Advisor - Technical Steward - TSMS

Main Purpose and Objectives

This position is part of the Technical Services & Manufacturing Sciences (TSMS) function and is responsible for stewardship and site transfer of commercial molecules, as well as commercialization support for new molecules. This position will interact with engineering, manufacturing, validation, quality assurance, quality control, development, and regulatory departments. Interaction may be required with other Lilly site/contract producers of Lilly products.

The successful candidate should have a proven track record of driving technical and manufacturing agendas in small molecule or peptides/oligonucleotides.

Key Responsibilities

• Provides technical oversight and stewardship for one or more molecules manufactured at the Lilly Houston facility.
• If necessary, leads the technical transfer of processes from one production facility to another, anticipating and addressing complex scale-up issues.
• Provides mentorship and scientific expertise to Process Team members monitoring, trending, and analyzing production data.
• Applies process knowledge and data analysis skills to support the management of daily manufacturing operations.
• May present process data and analyses with Process Team members at Manufacturing Process Team meetings.
• Drives solutions impacting results across sites or function.
• Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies.
• Reviews/approves Annual Product Review and presents annual Global Product Assessment for stewarded molecule(s).
• Leads resolution of technical issues including those related to control strategy and manufacturing.
• Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor.
• Anticipates and resolves key technical or operational problems that impact function or geography.
• Communicates issues in a timely manner. May lead process-related investigations and assess technical impact.
• Influences complex regulatory or technical issues within the TSMS area/function.
• Influences others to adopt a different point of view on difficult concepts.
• Writes standard operating procedures as they relate to the activities of the TSMS group.
• Reviews and approves manufacturing batch records and other manufacturing documentation.
• Works with Process Team members to ensure successful process knowledge transfer to the Manufacturing staff on the manufacturing floor.
• Assists in process-related training of Manufacturing Process Team members.
• As required, directly gathers additional supporting data on the manufacturing floor.
• As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories.
• Helps to define and implement medium to large continuous improvements to manufacturing processes.
• Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment.
• Helps to define and implement control strategies for Lilly Houston processes.
• Leads post launch technical agendas and delivers projects that drive substantial step changes in Manufacturing.
• As required, may lead, or assist in the planning and execution of process validation activities.
• As required, may own, or assist in the implementation of medium to large process-related change controls with greater risk, resource / financial requirements, or complexity.
• Makes decisions that impact a function or geography.
• Builds relationships with internal and external partners.

Minimum Requirements

• Minimum of 10 years of experience in cGMP small molecule, peptide, or oligonucleotide API commercial-scale manufacturing. Lesser years of experience will be considered under extraordinary circumstances or where consistent high-level performance measures have been sustained.
• Bachelor’s degree required, master's or PhD preferred
• Process and equipment knowledge of chemical synthesis active pharmaceutical ingredients.
• Thorough understanding of GMP requirements for a large-scale manufacturing facility.
• Demonstrated leadership skills.
• Excellent communication skills, both oral and written.

Additional Preferences

• Process validation, cleaning validation, and commercialization experience a plus.