Advisor - Technical Steward - TSMS
Eli Lilly and Company
3 months ago
On-site
Houston, TX
$117,000 - $189,200 USD yearly
Operations
Main Purpose and Objectives:
- Provide stewardship and site transfer of commercial molecules, and commercialization support for new molecules within the TSMS function.
- Interact with engineering, manufacturing, validation, quality assurance, quality control, development, and regulatory; may interact with other Lilly sites/contract producers.
Key Responsibilities:
- Provide technical oversight and stewardship for one or more molecules at the Lilly Houston facility; lead technical process transfers as needed, anticipating and addressing complex scale-up issues.
- Mentor Process Team members; monitor, trend, and analyze production data; support daily manufacturing operations; present analyses at Process Team meetings; drive solutions impacting results across sites/functions.
- Author technical reports for process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies; review/approve Annual Product Review and present annual Global Product Assessment.
- Lead resolution of technical issues related to control strategy and manufacturing.
- Troubleshoot issues with Process Teams and/or manufacturing staff on the floor; anticipate and resolve key technical/operational problems; communicate issues timely; may lead investigations and assess technical impact; influence complex regulatory/technical issues.
- Write TSMS-related SOPs; review/approve batch records and manufacturing documentation.
- Support process knowledge transfer to Manufacturing staff; assist with training; gather supporting data on the floor as required.
- Design lab experiments for troubleshooting and/or continuous improvement; execute/coordinate external lab work; define and implement medium-to-large continuous improvements.
- Support startup and validation of new facilities and associated equipment; define and implement control strategies.
- Lead post-launch technical agendas and projects that drive substantial manufacturing step changes.
- As needed, lead/assist process validation planning and execution.
- Own/assist medium-to-large process-related change controls with greater risk/complexity.
- Make decisions impacting a function/geography; build relationships with internal and external partners.
- Perform all responsibilities in compliance with safety, regulatory expectations, and cGMP.
Minimum Requirements:
- 10+ years’ experience in cGMP small molecule, peptide, or oligonucleotide API commercial-scale manufacturing (lesser experience considered under extraordinary circumstances with sustained high performance).
- 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 large-scale manufacturing.
- Demonstrated leadership skills.
- Excellent oral and written communication.
- Authorized to work in the United States full-time; Lilly will not sponsor visas.
Additional Preferences:
- Process validation, cleaning validation, and commercialization experience.
Other Information:
- Occasional travel (5–10%).
- Required to work onsite.
- Required to be on call.
- Shift work may apply.
- Provide stewardship and site transfer of commercial molecules, and commercialization support for new molecules within the TSMS function.
- Interact with engineering, manufacturing, validation, quality assurance, quality control, development, and regulatory; may interact with other Lilly sites/contract producers.
Key Responsibilities:
- Provide technical oversight and stewardship for one or more molecules at the Lilly Houston facility; lead technical process transfers as needed, anticipating and addressing complex scale-up issues.
- Mentor Process Team members; monitor, trend, and analyze production data; support daily manufacturing operations; present analyses at Process Team meetings; drive solutions impacting results across sites/functions.
- Author technical reports for process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies; review/approve Annual Product Review and present annual Global Product Assessment.
- Lead resolution of technical issues related to control strategy and manufacturing.
- Troubleshoot issues with Process Teams and/or manufacturing staff on the floor; anticipate and resolve key technical/operational problems; communicate issues timely; may lead investigations and assess technical impact; influence complex regulatory/technical issues.
- Write TSMS-related SOPs; review/approve batch records and manufacturing documentation.
- Support process knowledge transfer to Manufacturing staff; assist with training; gather supporting data on the floor as required.
- Design lab experiments for troubleshooting and/or continuous improvement; execute/coordinate external lab work; define and implement medium-to-large continuous improvements.
- Support startup and validation of new facilities and associated equipment; define and implement control strategies.
- Lead post-launch technical agendas and projects that drive substantial manufacturing step changes.
- As needed, lead/assist process validation planning and execution.
- Own/assist medium-to-large process-related change controls with greater risk/complexity.
- Make decisions impacting a function/geography; build relationships with internal and external partners.
- Perform all responsibilities in compliance with safety, regulatory expectations, and cGMP.
Minimum Requirements:
- 10+ years’ experience in cGMP small molecule, peptide, or oligonucleotide API commercial-scale manufacturing (lesser experience considered under extraordinary circumstances with sustained high performance).
- 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 large-scale manufacturing.
- Demonstrated leadership skills.
- Excellent oral and written communication.
- Authorized to work in the United States full-time; Lilly will not sponsor visas.
Additional Preferences:
- Process validation, cleaning validation, and commercialization experience.
Other Information:
- Occasional travel (5–10%).
- Required to work onsite.
- Required to be on call.
- Shift work may apply.