Advisor - Process Analytical Technology (PAT)

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.

Responsibilities:

The Process Analytical Technology (PAT) Advisor in the Analytical Quality Control Operations (AQCO) organization will serve as a technical lead on cross-functional teams to develop and implement PAT technical solutions and best practices that address key business and regulatory needs within Lilly. The PAT advisor is responsible for the development, deployment, transfer, and validation of on-line, at-line, and rapid analytical methods supporting drug substance and drug product areas for both legacy and new commercial products. The PAT advisor must possess expertise in chemometrics, multivariate data analysis, and artificial intelligence/machine learning (AI/ML) methods for calibration of analyzers and monitoring models for batch and continuous processes.

• Serve as a technical partner to Lilly Development organizations as they identify, test, and adopt PAT methods supporting drug substance and drug product processes. Must have the ability to interpret data from design of experiments (DOE) and quality by design (QbD) studies to select and optimize PAT methods.
• Provide design input, technical support, and independent review of PAT method characterization and suitability studies performed by Lilly Development organizations, for both large and small molecules.
• Develop validation plans and lead validation project activities for PAT methods being transferred or deployed to Manufacturing. Partner with Lilly sites and serve as a subject matter expert (SME) supporting successful deployment and implementation of PAT methods. Ensure consistent PAT solutions and practices across multiple sites utilizing the method. As needed, participate in post-launch troubleshooting and lifecycle management of deployed solutions.
• Provide strategic insights and support for real-time process monitoring and reporting solutions that combine critical quality attributes (CQAs) with critical process parameters (CPPs) to create advanced PAT models for prediction of product quality
• Lead technology surveillance and benchmarking of new PAT technologies that address gaps and create new solutions for Lilly M&Q.
• Serve as an analytical technology steward and central SME for assigned technology areas.
• Assist leadership in developing and implementing business strategy for appropriate PAT and rapid analytical methods.
• Author analytical procedures and lifecycle management documents in support of legacy molecule support and new molecule submissions.
• Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs.
• Help drive continuous improvement of the AQCO strategy for PAT by building effective collaborations and partnerships across Development and M&Q.
• Share key technical advances and achievements by actively participating in internal/external scientific forums, presenting at conferences, and producing publications and patents as appropriate.

Basic Requirements:

• Doctorate in Analytical Chemistry, Biochemistry, Pharmacy or equivalent training with pharmaceutical industry PAT experience.
• OR a bachelor's or master's degree in chemistry and at least 7-10 years of PAT experience in a pharmaceutical setting.
• Demonstrated skills using chemometrics (PCA, PLS, PLS-DA), multivariate analysis, and/or AI/ML methods to build calibration, monitoring, classification, and/or control models for PAT applications

Additional Skills/Preferences:

• Knowledge and expertise in spectroscopic (NIR, mid-IR, Raman, fluorescence) and chromatographic (HPLC, UPLC, GC, and LC-MS) methods of analysis
• Experience with characterization and validation of analytical equipment and methods
• Deployment of PAT equipment and methods into a GMP production environment
• Experience with spectroscopic solutions and multivariate monitoring models for cell culture processes
• Capable of designing and executing experiments, analyzing experimental results, coordinating, directing, and reviewing the work of others, and effectively communicating results
• Exceptional interpersonal skills with ability to work and establish trust within a cross-functional, interdisciplinary team environment
• Effective communication, self-management, and project leadership skills
• Fundamental knowledge of cGMP/GLP compliance
• Strategic planning, networking, and change management
• Continuous learner

Additional Information:
Travel % This role is located onsite at the Indianapolis Lilly Technology Center North

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
$121,500 - $198,000

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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