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 moleculeslocatedinHouston, 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 thestartupteam for a greenfield manufacturing site, and the successful candidate will help build theprocesses andfacilityto enable a successful startup into GMP manufacturing operations.
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Main Purpose and Objectives:???
This position ispart of the Technical Services & Manufacturing Sciences (TSMS) function andisresponsible forstewardship 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 mayberequiredwith other Lilly site/contract producers of Lilly products.
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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 proventrack recordof driving technical and manufacturing agendas in smallmoleculeor peptides/oligonucleotides.?
Key Responsibilities:??
Provides technical oversight and stewardship for one or more molecules manufactured atthe Lilly Houstonfacility.?If necessary,leadsthe technical transferof processes from one production facility to another,anticipatingand addressing complex scale-up issues.??
Provides mentorship and scientificexpertiseto Process Teammembersmonitoring, 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 solutionsimpactingresults across sites orfunction.??
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 thatimpactfunction or geography.Communicatesissuesin 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 successfulprocessknowledge transfer to the Manufacturing staff on the manufacturing floor.Assistsin process-related training of Manufacturing Process Team members. As required, directly gathersadditionalsupporting 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 LillyHoustonprocesses.
Leads post launch technical agendas anddeliversprojects that drive substantial step changes in Manufacturing.??
As required, may lead, orassistin the planning and execution of process validation activities.????
As required, may own, orassistin the implementation of medium to large process-related change controls with greater risk, resource / financial requirements, or complexity.?
Makes decisions thatimpacta function or geography.Buildsrelationships with internal and external partners.?
Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP.?
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MinimumRequirements:?
Minimum of 10 years of experience in cGMP smallmolecule, peptide, or oligonucleotideAPIcommercial-scalemanufacturing.?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 ofchemical synthesisactive pharmaceutical ingredients.?
Thoroughunderstanding 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:?
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Other Information:?
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 () 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
$66,000 - $209,000
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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