Advisor - Technical Steward - TSMS

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, Texas.  This facility is intended to provide APIs for current and future products, including new modalities.  This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help build the processes and facility to enable a successful startup into GMP manufacturing operations. 

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.

This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.  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. 

• Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP.  

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.

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:  

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

Other Information:  

• Occasional travel required 5 – 10%.  

• Required to be working onsite.  

• Required to be on call.  

• Shift work may apply.   

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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