Sr. Principal Chemist

BioSpace; Concord (NC); On-site; USD 116,000 - 169,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Well-being programs

Job summary

Lilly is seeking a qualified scientific professional to provide analytical leadership in QC labs. The role involves mentoring staff, overseeing method transfer and validation, and ensuring compliance with GMP and data integrity across lab operations.

Responsibilities include partnering with global Quality Labs to implement best practices, supporting Lean Lab initiatives, and engaging with auditors and partners to ensure inspection readiness.

Qualifications

• Bachelor or Masters in a science or engineering discipline (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)
• GMP Laboratory experience including familiarity with analytical testing, method transfer, and method validation.
• Experience with enterprise chromatography systems and LC instruments.
• Experience with statistics and data analysis software, especially data visualization.
• Qualified candidates must be legally authorized to be employed in the United States; no visa sponsorship provided.

Responsibilities

• Provide analytical support, project leadership, and technical direction.
• Oversee the transfer of analytical methods for marketed products, including documentation and validation.
• Interact with global Quality Labs to adopt best practices for testing and investigations.
• Ensure methods and procedures comply with Quality Standards and data integrity.
• Support Lean Lab and efficient lab operations.
• Collaborate with auditors and business partners.

Skills

GMP Experience

Analytical testing

Method transfer

Method validation

LC Instruments

Chromatography systems

Statistics & data viz

Data integrity

Mentoring

Education

BSc/MSc in Science or Engineering

Tools

Empower

LabVantage LIMS

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Responsibilities

The position is responsible for technical mentoring of lab staff and sharing technical information and best practices within the work group and across plant sites. Participates and influences the design and installation of systems, procedures, and methods for the Chemical and Device Testing labs at the site.

Key Objectives/Deliverables

• Provide analytical support, project leadership, and/or technical direction, and perform laboratory analyses and data review as needed.
• Oversee and participate in the transfer of analytical methods for marketed products, including setting strategic direction, authoring and reviewing method certification documentation, execution of laboratory testing, and investigation of observations.
• Interact with global Quality Labs and other commercial QC Labs to identify and adopt best practices for testing, documentation, and investigations.
• Ensure methods, procedures and practices adhere to Lilly Global Quality Standards and regulatory requirements, including data integrity.
• Supporting Lean Lab and efficient lab operations
• Network with other areas and externally to understand best practices, share knowledge, participate in technical planning, and to ensure customer needs are met.
• Help define and execute inspection readiness activities in the QC laboratories.
• Interact effectively with auditors and business partners.

Basic Qualifications

• Bachelor or Masters in a science or engineering discipline (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)
• GMP Laboratory experience including familiarity with analytical testing, method transfer, and method validation.
• Previous experience with enterprise chromatography systems and standalone COTS testing instruments.
• Previous experience with LC instruments.
• Experience with statistics and data analysis software, especially data visualization
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the P path.

Additional Skills/Preferences

• Experience with Empower and LabVantage LIMS.
• Strong technical aptitude and ability to train and mentor others.
• Understanding of compliance requirements and regulatory expectations.
• Working effectively with a cross functional group.
• Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering, and IT personnel.
• Ability to focus on continuous improvement.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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

$115,500 - $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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