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Research Associate-QC Stability

Branchburg Township, New Jersey

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Req ID R-2744 Title Research Associate-QC Stability City Branchburg State / Province New Jersey Country United States

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.

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world.We produce our medicinesusing some of the most sophisticated manufacturing technologies and rigorous quality standards.Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Required Knowledge, Skills and Education

1. B.S. or M.S. in Chemistry, Biochemistry, or related science.

2. 5-7 years of either QC or developmental experience with large molecules.

3. Technical knowledge of the QC assays used to monitor the stability of protein molecules.

4. Previous experience in stability study or protein degradation, and/or basic knowledge of statistical analysis is not required but a definite asset.

5. Working knowledge of cGMP is required.

Primary Responsibilities

1. Performance and oversight of routine duties for maintenance of the Stability Program. Coordinate and facilitate completion of all stability-related tasks with coworkers and testing laboratories.

2. Write Stability protocols, initiate stability studies, pull stability samples, manage and perform stability incubator periodic cleaning, evaluate stability data trends, stability-related change controls, perform investigations and review/approve stability timepoints.

3. Exhibit good communication skills with the QC testing laboratories and facilitate the timely completion of the stability samples. Accurately communicate critical stability data and trends upward to QC management, propose a path forward and manage investigations.

4. Using scientific knowledge based on experience with stability studies, compile, analyze trends and write stability summary reports and regulatory submission stability sections and annual product reviews.

5. Consistently deliver a high level of quality in written work. Conduct thorough and accurate document reviews, including stability data filed in regulatory submissions.

6. Exhibit strong teamwork skills. Assist department management with training and development of junior staff.

7. Use scientific expertise to provide assistance to coworkers for troubleshooting, laboratory investigations and problem resolution. Suggest process improvements to QC management.

8. Update supervisor of progress at regular intervals. Demonstrate sound judgment in making decisions, seeking additional guidance as needed.

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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-2744.

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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