Sr. Principal Chemist

Initial Therapeutics, Inc.; Concord (NC); On-site; USD 65,250 - 169,400; Full time

Benefits offered by this job

Comprehensive benefit program

Eligibility for company-sponsored 401(k)

Job summary

Initial Therapeutics, Inc. is seeking a professional for a critical role focused on technical mentoring and the analysis of laboratory methods. The successful candidate will provide leadership in laboratory operations, ensuring that methods adhere to strict quality and regulatory standards.

With a strong focus on continuous improvement and collaboration with cross-functional teams, you will oversee laboratory analyses and support compliance efforts. Join us to drive advancements in qualitative testing within a dynamic team.

Qualifications

• Experience with statistics and data analysis software.
• Familiarity with enterprise chromatography systems.
• Ability to mentor and train lab staff.

Responsibilities

• Provide analytical support and technical direction.
• Oversee the transfer of analytical methods.
• Ensure adherence to Lilly Global Quality Standards.

Skills

GMP Laboratory experience

Experience with analytical testing

Strong technical aptitude

Excellent communication skills

Education

Bachelor or Masters in a science or engineering discipline

Tools

Empower

LabVantage LIMS

LC instruments

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

• Education:
  • Bachelor or Masters in a science or engineering discipline (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)
• Experience:
  • 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.

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.

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

$65,250 - $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.