Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX. 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 to build the processes and facility to enable a successful startup into GMP manufacturing operations
Job Position Overview:This role serves as a technical leader within the QC laboratory, driving advancement of analytical methods, systems, and overall testing capability while guiding complex scientific decisions. The position leads the site's Process Analytics Technology (PAT) and QC laboratory automation strategy, partnering closely with Manufacturing, Automation/Engineering, and Digital teams to integrate in-line, on-line, and at-line analyzers and automated lab systems into a greenfield facility build-out. It partners cross-functionally to solve challenging technical issues, influence broader quality and manufacturing strategies, and serves as a QC subject matter expert for site and global initiatives.
This position is a recognized expert who makes key technical decisions impacting multiple teams, leads the resolution of highly complex challenges, and influences technical strategy across functions. The role delivers innovations with cross-functional impact, leads significant initiatives, mentors outside their own discipline, and serves as an effective supporter of culture change.
Responsibilities:
- Provide technical leadership for the QC laboratory by guiding the development and improvement of testing methods, quality systems, and analytical capabilities while serving as a technical authority in complex decision-making forums.
- Serve as site lead for Process Analytics Technology (PAT), driving the selection, qualification, and lifecycle management of in-line, on-line, and at-line analyzers, and defining the site's PAT roadmap in alignment with the overall QC and manufacturing control strategy.
- Lead QC laboratory automation initiatives, including LIMS/LES integration, automated sample handling and robotics, and data historian connectivity, to improve throughput, right-first-time performance, and data integrity across the QC organization.
- Lead the resolution of complex technical challenges by applying advanced scientific knowledge across multiple disciplines and designing novel solutions that enhance accuracy and efficiency across QC operations.
- Collaborate and influence across Manufacturing, Quality Assurance, Technical Services, Regulatory, Product Development, Automation/Engineering, and Digital, as applicable, to integrate QC considerations into broader business decisions and serve as a subject matter expert during regulatory inspections and audits.
- Execute all Quality Control activities in a timely manner, in compliance with applicable SOPs, methods/protocols, good documentation practices, data integrity standards (ALCOA+), cGMPs, EHS requirements, chemical hygiene, and biosafety guidelines, maintaining an ongoing state of inspection readiness and providing support during audits and inspections as requested.
- Identify and escalate atypical results and potential deviations, participate in root cause investigations and corrective/preventive actions, contribute to cross-functional teams and continuous improvement initiatives, and maintain training competencies to ensure only qualified work is performed.
Basic Qualifications:- Education Level: Minimum, bachelor's degree in science or engineering or equivalent experience
- Experience: Minimum 5 years of laboratory experience in pharmaceutical or related industry
- Certifications: N/A
- Licenses: N/A
- Language Requirements: N/A
- Required Skills Testing: N/A
- 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 Skills/ Preferences:- Extensive experience providing advanced technical oversight in a GMP-regulated QC laboratory, including comprehensive data review, troubleshooting methods, and scientific decision-making for complex analytical or microbiological issues.
- Experience with Process Analytical Technology (PAT) instrumentation and platforms (e.g., NIR, Raman, or other in-line/on-line/at-line analyzers), including selection, qualification, and integration with manufacturing control systems, is preferred.
- Experience with QC laboratory automation and informatics systems (e.g., LIMS/LES, automated sample handling, robotics, or data historians), including implementation or lifecycle support, is preferred.
- Proven track record of leading or significantly contributing to analytical method transfers, validations, and lifecycle management activities, with the ability to author technical protocols, reports, and regulatory submissions.
- Demonstrated ability to serve as a subject matter expert during regulatory inspections and audits, including the ability to clearly articulate scientific rationale, defend analytical strategies, and respond to complex technical questions.
- Experience influencing cross-functional decisions (Manufacturing, QA, Regulatory, Product Development) through technical credibility and data-driven recommendations, with a track record of driving QC-initiated improvements at the site or global level.
- Prior experience mentoring QC scientists and technicians on advanced analytical concepts, emerging technologies, and structured problem-solving approaches, contributing to overall team capability development.
- Proficient in good documentation practices (GDP) and data integrity principles (ALCOA+).
- Proven ability to communicate and collaborate effectively with cross-functional teams.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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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