Advisor - TS/MS - Oligonucleotides Technical Steward

Lilly • Houston, TX

2d • $130,500 - $211,200

About The Position

Lilly is constructing an advanced API manufacturing facility in Houston, Texas, intended to produce APIs for current and future products, including new modalities. The role is part of the startup team for this greenfield site and will help establish processes and facilities for successful startup into GMP manufacturing operations.

As part of Technical Services & Manufacturing Sciences (TSMS), the position is responsible for oligonucleotide stewardship and site transfer of commercial molecules, as well as commercialization support for new molecules. The role works with engineering, manufacturing, validation, quality assurance, quality control, development, and regulatory departments, and may interact with other Lilly sites and contract producers.

The successful candidate brings comprehensive knowledge of the pharmaceutical industry, GMP, regulatory requirements, and oligonucleotide technical and manufacturing agendas. The position provides technical oversight for molecules manufactured at the Houston facility; supports manufacturing operations and process teams through scientific expertise, data analysis, troubleshooting, technical documentation, training, process improvement, validation, and commercialization; and contributes to facility startup and process control strategies. The position requires compliance with safety, regulatory, and cGMP expectations. Off-hours support may be requested, including responding to operational issues off shift. Minimal travel is required.

Requirements

• Bachelor's degree in Chemistry, Microbiology, Biochemistry, Biochemical Engineering, or a related science field.
• At least 10 years of experience in cGMP oligonucleotide, peptide, or small-molecule API commercial-scale manufacturing.

Nice To Haves

• Master's or PhD.
• Process validation, cleaning validation, and commercialization experience.
• Demonstrated leadership skills.
• Excellent oral and written communication skills.
• Process and equipment knowledge of chemical synthesis active pharmaceutical ingredients.
• Thorough understanding of cGMP requirements for a large-scale manufacturing facility.

Responsibilities

• Provide technical oversight and stewardship for one or more molecules manufactured at the Lilly Houston facility.
• Lead technical process transfers between production facilities when needed, anticipating and addressing complex scale-up issues.
• Mentor Process Team members in monitoring, trending, and analyzing production data; apply process knowledge and data analysis to support daily manufacturing operations.
• Present process data and analyses with Process Team members at Manufacturing Process Team meetings as needed.
• Drive solutions that impact results across sites or functions.
• Author technical reports supporting process control strategies, technology transfers, process validation, deviation and adverse event reporting, process monitoring and analyses, and technical studies.
• Review and approve Annual Product Reviews and present annual Global Product Assessments for stewarded molecules.
• Lead resolution of technical issues, including issues related to control strategy and manufacturing.
• Troubleshoot with Process Teams and manufacturing staff on the manufacturing floor; communicate issues promptly and anticipate and resolve technical or operational problems.
• Lead process-related investigations as needed and assess technical impact; influence complex regulatory or technical issues within the TSMS area or function.
• Write standard operating procedures related to TSMS activities and review and approve manufacturing batch records and other manufacturing documentation.
• Support process knowledge transfer to Manufacturing staff and assist with process-related training; gather supporting data on the manufacturing floor as needed.
• Design laboratory experiments for process troubleshooting or continuous improvement and execute them or coordinate execution in outside laboratories as needed.
• Help define and implement medium- to large-scale continuous improvements to manufacturing processes.
• Support startup and validation of new facilities and associated process equipment, and help define and implement control strategies for Lilly Houston processes.
• Lead post-launch technical agendas and deliver projects that drive substantial improvements in Manufacturing.
• Lead or assist with planning and execution of process validation activities as needed.
• Own or assist with implementation of medium- to large-scale process-related change controls involving greater risk, resource or financial requirements, or complexity as needed.
• Make decisions affecting a function or geography and build relationships with internal and external partners.
• Perform all job responsibilities in compliance with safety, regulatory, and cGMP expectations.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior