Sr. Scientist-QC Biochemistry

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.

Organization Overview:

Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do to deliver a reliable supply of medicine for people around the world.

Position Brand Description:

Conduct routine and non-routine analyses of in-process materials, raw materials, environmental/water samples, finished goods and stability samples by appropriate biochemical methods as assigned by supervisor. Perform routine QC responsibilities as needed. Apply acceptable cGMP practices during execution of all work tasks. Work independently with moderate supervisory guidance.

Responsibilities:

Manage for Results /Strategic Planning:

Perform routine QC responsibilities as assigned by supervisor such as (as applicable):

• Conduct analyses of test articles as assigned by supervisor by appropriate biochemical methods such as: HPLC, CESDS, SDS-PAGE, UV-Vis, turbidity, osmolality, pH, etc.

• Demonstrate initiative to perform routine QC responsibilities such as sample reconciliation and inventory control, lab equipment maintenance and calibration, write and/or revise QC documents, and perform sample requests/documents as needed.

• Investigate atypical results or system suitability failures.

• Understands and verifies audit trail entries in electronic/computerized systems.

• Familiarity with USP and other compendial testing.

• Share expertise with other team members. May coach, mentor, or train other analysts on various procedures or technologies.

• Monitor laboratory equipment for temperature and conformance to specifications.

• Apply acceptable cGMP practices during execution of all work tasks.

• Work independently with minimal supervisory guidance. Exhibit strong teamwork skills.

• Update supervisor of progress at scheduled intervals. Seek additional guidance as needed.

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

• Perform assay data review.

Perform independent assignments such as

• Compile data and prepare graphs for documentation of test procedures and for reports/presentations.

• Conduct document reviews, author standard operating procedures (SOPs), and assay review.

• Lead special projects such as method validation, troubleshooting, optimization, and investigations.

Basic Requirements:

• BS or MS in a related science (such as a Biology, Biochemistry, or Chemistry) with a minimum of 3 - 5 years of related experience.

• Good working knowledge of cGMP regulations and past experience in a GMP environment is required.

• Previous experience using Empower or other data acquisition systems.

Additional Skills/Preferences:

• Ability to work independently with moderate supervisory guidance.

• Clear, concise communication skills; both written and verbally.

• Excellent teamwork skills.

• Attentive to detail.

• Proficiency in computer applications is desired, especially in software that controls instruments (e.g., Empower or other chromatography systems, LIMS, Lab Solutions, or various firmware).

Additional Information:

• Must be able to work on a Saturday or Sunday. Flexible schedules are available, which include Tuesday - Saturday (8 hour days) or Wednesday - Saturday (10 hour days).

• Travel not required.

• Lifting not required.

• Not required to be on call.

• Shift work may apply.

• Location: Branchburg, NJ

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 ( ~~~ ) 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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