Philadelphia, Pennsylvania

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.

Company Overview:

Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare. For more information, visit www.avidrp.com.

Position Overview:

The Senior Technical Operations Specialist is responsible for troubleshooting production issues with Contract Manufacturing Organization (CMO) sites, assisting with test method and production process changes, tracking production failure root causes, helping to implement improvements aimed at correcting production problems, providing technical input for production changes, and reviewing CMO investigations.

Responsibilities:

  • Assist/Lead investigations into defects and failures in the field
  • Troubleshoot Quality Control (QC) test method and production issues with CMO sites for the assigned region. Coordinate with the Radiochemistry & Radiopharmaceutical Development and Analytical Development and Quality Control teams as necessary.
  • Identify and track root causes for production failures, and support programs /solutions to improve site production performance
  • Conduct site visits to CMO sites to troubleshoot issues and/or to observe production and testing of Avid products and review for compliance with Avid approved procedures and PET GMP regulations.
  • Assist with supplemental training of CMO site staff during site visits to correct deficiencies
  • Assist with roll out of revised major QC test procedures or production processes to CMO
  • Lead data analysis projects for batch data for global CMOs for all products
  • Create technical summaries and trending reports based off all incoming batch data.
  • Support projects related to management of incoming batch data for global CMOs for all products
  • Review and assess all changes to technical documents and for process improvement discussions with the CMOs
  • Author technical documents including but not limited to testing protocols,  technical reports, and SOPs
  • Review completed manufacturing batch documentation
  • Support technology transfer and new site start-up as needed

Basic Qualifications:

  • Bachelor’s degree in a scientific or technical area

Additional Skills/Preferences:

  • 3 years of experience preferred
  • Advanced degree preferred in a scientific or technical area
  • Knowledge of cGMP drug substance/drug product manufacturing and quality control
  • Impeccable organizational skills
  • Ability to work independently in a highly focused manner
  • Excellent interpersonal skills and ability to collaborate with internal and external parties
  • Superior written and verbal communication skills
  • Excellent computer skills (e.g. Excel, Word, and PowerPoint)

Additional Information:

  • Must be willing and able to travel within the US and worldwide 30% of the time

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

Philadelphia, Pennsylvania

Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
We were founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that meet real needs. More than a century later, we are passionate about building on this precedent in our continued pursuit to make life better for individuals, communities, and the world around us.
Our heritage and our values are the foundation of our promise to unite caring with discovery to make life better for people around the world.
Our mission 
We make medicines that help people live longer, healthier, more active lives.
Our values
Integrity, excellence, respect for people
Our vision 
We will make a significant contribution to humanity by improving global health in the 21st century.

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