Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.
The Lebanon Advanced Therapies (LP2) Quality Assurance External Manufacturing Representative is responsible for demonstrating leadership, teamwork, and quality/regulatory knowledge to provide effective quality oversight of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination.
LP2 External Manufacturing Quality Assurance maintains communication and working relationships with alliance partners, contract manufacturers, and internal customers. The External Manufacturing QA Representative manages daily contract manufacturing activities and ensures adherence to Lilly GQS and cGMPs through deviation investigations, change control, documentation management, validations, and other relevant responsibilities. This position also supports inspection readiness, product launches, and is accountable for batch disposition, confirming all batches comply with specifications and regulatory requirements.
Responsibilities: - Serve as a liaison between CMs and Lilly, providing quality oversight and serving as the initial point of contact for all quality-related issues
- Escalate quality issues at CMs to Lilly QA management.
- Assist in the establishment and revisions of Quality Agreements with affiliates and customers
- Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs)
- Evaluate and disposition drug substance, drug product, and packaging batches ensuring that documented checks have been completed for the Certificates of Testing, Certificates of Environmental Monitoring (where applicable), deviations, changes and batch documentation
- Provide quality support of manufacturing operations with holistic review of key activities associated with or impacting the manufacturing processes.
- Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product
- Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations
- Provide onsite support of manufacturing operations as required
- Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections
- Participate in APR activities
- Participate in Post Launch Optimization Teams (PLOT)
Basic Requirements:- Bachelor's degree in relevant field (preference for scientific or engineering field).
- 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles.
- Previous experience providing Quality Assurance oversight of contract manufacturers.
- 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:- Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
- ASQ Certified
- Previous facility or area start up experience
- Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging
- Previous experience with Manufacturing Execution Systems.
- Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills
- Demonstrated strong problem solving and decision-making skills
- Previous technical writing experience
- Technical aptitude and ability to train and mentor others
Additional Information:- Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office
- Position may require travel (10-25%)
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
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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