Sr. Principal Scientist - Quality Control Compliance

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 35,000 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 employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.

Position Brand Description:

The Principal Scientist – Quality Control (QC Responsible Scientist) performs holistic data reviews, interprets results, and releases data for the QC Laboratories. The Responsible Scientist utilizes their experience and technical skills to assist laboratory analysts with problem solving and leads critical investigations.

The Responsible Scientist will be involved in and advise on commercialization and technical agenda projects such as method validations, qualifications, method transfers, and equipment evaluation and qualification. The position is responsible for the technical mentoring of lab staff and sharing of technical information and best practices within the work group and across network laboratories.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

• Contributes to Annual Product Reviews as required.
• Responsible for analytical monitoring, compliance and campaign readiness for specific products.
• Ensure QC is in alignment with Global Quality Standards and Critical Quality Practices through gap assessments and relative evaluations.
• Perform in-depth second tier holistic review including data integrity and technical assessment of all analytical testing associated with the batch, stability, reference standard characterization, and production testing support prior to the release of individual test data and issuance of Certificate of Testing.
• Perform mentoring, coaching, and technical training of laboratory analysts.
• Interacts effectively with business partners to communicate and resolve issues. Understands business requirements of the other functions.
• Performs periodic evaluation of method performance within the lab.
• Lead and oversees method transfer activities.

• Supports/participates in regulatory inspections and commitments.
• Evaluates and recommends new technologies for the QC Laboratories.
• Work with Regulatory Affairs to provide information and data supporting regulatory submissions. Writes and publishes technical reports and memos.
• Leads/initiates change controls, investigations, observations, and deviations.

Manage Relationships with Key Stakeholders and Customers:

Production, Technical Services, Regulatory Affairs, Global Quality Laboratories

Basic Requirements:

• Master/PhD in Chemistry, Biochemistry or related science with a minimum of 5-10 years’ experience in a cGMP (analytical or biology) environment.
• Understanding of compliance requirements and regulatory expectations.
• Prior experience working in a GMP analytical laboratory with demonstrated proficiency in complex laboratory analysis.

Additional Preferences:

• Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic, and/or microbial assays.
• Strong written and verbal communication skills.
• Strong problem-solving skills with experience in Root Cause Analysis.
• Experience with a broad range of analytical techniques applicable to monoclonal antibodies, including (cell-based) bioassays, qPCR and ELISA methods.
• Knowledge of ICH guidelines applicable to biotech drug substance.
• Strong quality and safety mindset.

Other Information:

• Shift work does not apply.
• Travel: 0-10%
• Lifting not required.
• On call and weekend work when necessary.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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