Sr. Principal Chemist

Initial Therapeutics, Inc.; Durham (NC); On-site; USD 63,000 - 163,000; Full time

Job summary

An established industry player is seeking a Sr. Principal Chemist to lead analytical testing and method validation in a dynamic laboratory environment. This role involves reviewing analytical data, authoring technical documents, and providing regulatory expertise to support product release and compliance. The ideal candidate will have a strong background in chemistry and experience with laboratory instrumentation, ensuring the highest standards of quality and efficiency. Join a forward-thinking company dedicated to improving lives through innovative healthcare solutions, where your contributions will make a significant impact on life-changing medicines.

Benefits

Company bonus

Comprehensive benefit program

Flexible working hours

Professional development opportunities

Qualifications

• Bachelor's degree in Chemistry, Biology, or Microbiology required.
• Relevant experience in a chemistry lab is necessary.

Responsibilities

• Review and release analytical results for product testing.
• Lead method deployment and laboratory improvement initiatives.
• Provide technical leadership and regulatory expertise.

Skills

Analytical Skills

Problem Solving

Technical Leadership

Regulatory Expertise

Interpersonal Skills

Organizational Skills

Attention to Detail

Education

Bachelor's degree in Chemistry

Bachelor's degree in Biology

Bachelor's degree in Microbiology

Tools

LIMS

Empower3

TrackWise

HPLC

CE instruments

Job description

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.

Position Description:

The Sr. Principal Chemist reviews, interprets, and releases analytical results for the laboratory in support of product/material batch release, in-process product testing, protocol driven testing and investigational testing. The Sr. Principal Chemist leads method deployment activities, including authoring method validation, verification and/or transfer protocols and reports, supporting method familiarization/evaluation activities and providing oversight to associated project plans. Additionally, the Sr. Principal Chemist will lead or assist in the onboarding on laboratory instrumentation and equipment, including authoring/reviewing/executing change controls and related actions, authoring/reviewing IQ/OQ/PQ protocols and reports, authoring/reviewing standard operating procedures and training materials as well as working with and/or overseeing certified service providers during instrument installation or repair activities. The Sr. Principal Chemist will be required to perform routine and non-routine laboratory testing and training and mentoring of laboratory personnel, as needed. The Sr. Principal Chemist will be required to utilize technical and regulatory expertise to assist in inspection/audit activities, laboratory investigations as well continuous improvement activities.

Key Objectives/Deliverables:

• Review analytical data generated by other analysts within the lab as required.
• Provide technical leadership within the laboratory team, cross-functionally and across sites.
• Provide technical knowledge relative to scientific principles required for testing of drug substance, drug product and raw materials including product and material properties relative to analytical attributes.
• Lead investigation processes, including root cause analysis and CAPA.
• Provide regulatory expertise in support of internal and external auditing processes.
• Author technical documents.
• Participate in laboratory improvement initiatives, as required.

Requirements (Education, Experience, Training):

• Bachelor (4-year college) degree in Chemistry, Biology or Microbiology and Relevant experience in a chemistry lab.
• 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 this employment position.

Preferred attributes but not required:

• Experience with electronic laboratory management systems (E.g., LIMS, LES, ELN)
• Experience with Empower3 and TrackWise.
• Experience with change control, analytical and deviation investigations, including root cause analysis and CAPA.
• Laboratory experience with HPLC and CE instruments.
• Demonstrated problem solving and analytical thinking skills.
• Understanding of statistical tools and trend analysis.
• Excellent interpersonal skills and networking skills.
• Strong self-management and organizational skills.
• Experience in a GMP environment.
• Demonstrated written and verbal communications skills.
• Strong attention to detail.
• May be required to provide on call support.
• Demonstrated ability to work both independently and as a part of a Team.

Additional Information

• 8-hour days – Monday through Friday.
• May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.
• Applicant will work in various areas within the site. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Tasks may require repetitive motion (E.g., keyboarding).
• Minimal travel required.

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.

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 $63,000 - $162,800.

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.

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