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Research Assoc-QC Biochemistry

Branchburg Township, New Jersey

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Req ID R-18409 Title Research Assoc-QC Biochemistry City Branchburg State / Province New Jersey Country United States Region Research

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 35,000 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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:

Perform routine duties of the maintenance of the Stability Program and the stability data base. Complete all stability-related tasks with coworkers and testing laboratories.

  • Author stability studies and protocols to support routine manufacturing and investigations/change controls
  • Monitor the stability pull schedule and ensure that samples are pulled and delivered to the laboratory on time.
  • Proactively and effectively communicate with the QC testing laboratories and facilitate the timely completion of the stability samples. 
  • Communicate critical stability data and trends upward to QC management. 
  • Provide stability data necessary for the submission of various regulatory documents ensuring data accuracy and integrity.
  • Monitor stability results and report any unexpected or adverse trends. Provide stability data to other departments upon request ensuring data accuracy and integrity.
  • Author stability protocols with input from development groups and regulatory on design. Compile and write summary reports for the stability profile of the products.
  • Contribute to the stability section of annual product reviews and regulatory filings. Write/revise SOPs. Conduct document reviews.
  • Demonstrate initiative to assure performance of routine QC responsibilities.
  • Apply good cGMP practices during execution of all work tasks.
  • Assist coworkers in troubleshooting, laboratory investigations and problem resolution.
  • Suggest process improvements to QC management.
  • Work independently with supervisory guidance.

Basic Qualifications:

  • B.S. or M.S. in Biological Science, Chemistry, or related field. B.S. requires 1-3 years, M.S. requires 0-1 years of either QC or developmental experience with protein molecules in a biotechnology setting, industrial environment preferred. Some Technical knowledge of the QC assays used to monitor the stability of protein molecules.
  • Previous experience in stability study or protein degradation, and/or basic knowledge of statistical analysis is not required but a definite asset.
  • Working knowledge of cGMP.

Additional Skills/Preferences:

  • Excellent teamwork and communication skills.
  • Attentive to detail. 
  • Good computer skills.
  • Ability to work independently and achieve problem resolution with minimal supervision

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.


As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
 

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-18409.

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.

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