QC Principal Chemist- Batch release

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

$63,000 - $162,800

Company Overview:

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 39,000 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. #WeAreLilly

Organization Overview:

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.  The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

Position Brand Description:

The QC Principal Chemist reviews, interprets, and releases batch results for the laboratory. The Principal Chemist utilizes their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement and completes thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented.

Key Objectives/Deliverables:

• Technical review, interpretation and release of data including CoT issuance, stability results and reference standard characterization.
• Contributes to APR and process validations as required.
• Author and review change controls and deviations.
• Review and interpret data and document results of analyses and conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines.
• Utilize technical skills to lead or perform in - depth investigations into out of spec results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
• Develop investigational testing protocols.
• Provide technical oversight for Periodic Management Reviews.
• Communicate effectively in both written and oral formats within the lab as well as with external customers and business partners.
• Perform data entry and reviews work for accuracy in accordance with laboratory procedures, standards, and GMP requirements.
• Maintains a safe work environment, works safely, and is accountable for supporting all HSE Corporate and Site goals.

Basic Experience Requirements:

• Teamwork and interpersonal skills
• 7+ years of demonstrated relevant experience in a GMP lab.
• Demonstrated accuracy and proficiency in analytical skills
• Demonstrated strong problem - solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology
• Strong oral and written communication skills and demonstrated through documentation and presentation skills

Education Requirements:

• Bachelors’ Degree in a science field

Additional Skills/Preferences:

• Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic and spectroscopic assays.
• Deep understanding of compliance requirements and regulatory expectations.
• Proficiency with computer systems including Microsoft Office products, LIMS, Empower, etc.
• Ability to work in a lab environment including wearing appropriate PPE and other safety required equipment and considerations.
• Ability to work in a highly regulated environment.
• Demonstrated documentation skills.

Other Information:  

• 8 hour days – Monday through Friday
• Travel may be required during project phase.
• Ability to work in various areas within the site.  Some allergens