Director - Process Analytical Technology Scientist

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.

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

$144,000 - $250,800

Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:
The Process Analytical Technology (PAT) Scientist in the Global Quality Laboratories organization directs multi-functional project teams to develop and implement technical solutions and best practices that address key business and regulatory needs for the corporation. The PAT scientist is responsible for supervising a team in the development and utilization of rapid analytical methods across in-process, drug substance, and drug product samples in accordance with GMP requirements.

• As the team leader, this position will provide analytical support, project leadership, and/or technical direction for projects supporting the Lilly Manufacturing and Quality and Lilly Development organizations.,.

• Champion the development, assessment, and implementation of technical solutions for Lilly M&Q components with a focus on PAT and rapid analytical methods.

  • Identify capability/technology gaps and justify/champion investment.

  • Assist corporate leaders in developing and implementing business appropriate PAT and rapid analytical technical strategies.

• Author analytical procedure 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.

  • Drive analytical procedure continuous improvement efforts.

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• Develop productive technical collaborations and partnerships across M&Q components.

  • Ensure consistent practices between global laboratories.

  • Mentor technical talent.

  • Influence the internal and external environment:  Openly share key technical developments including contributions to internal/external scientific forums.

  • May also be responsible for supervision, performance management, and technical/professional development of a small technical team.

Basic Requirements:

• Doctorate in Chemistry, Biochemistry, Pharmacy or equivalent experience; industry related experience in pharmaceuticals and PAT.

• 20+ Years of experience in pharmaceuticals and PAT

Additional Skills/ Preferences:

• Experience with chemometric techniques including but not limited to spectroscopy (e.g., NIR, Raman, Fluorescence), process monitoring, machine learning and AI is desirable.

• Demonstrated expertise in instrumental methods of analysis.

• Capable of designing and executing experiments, analyzing experimental results, coordinating, directing, and reviewing the work of others, and effectively communicating results.

• Experience in chemometrics (e.g., PCA, PLS, PCA-DA).

• Effective communication, self-management, and team leadership skills.

• Must be able to supervise and work productively in a cross-functional, interdisciplinary team environment.

• Fundamental knowledge of cGMP/GLP compliance requirements.

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.