Lilly Consultant-QC Micro CoT Release in Indianapolis, Indiana

41369BR

Responsibilities:

Responsibilities

You will review and interpret data, and release batch results for the laboratory, while leading the design and execution of method development and validations, technology transfers, and equipment evaluation and qualification. You may perform non-routing lab work in support of those projects, and utilize your technical skills to perform in-depth problem solving, actively find opportunities for continuous improvement and complete thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions and action plans are thoroughly and accurately documented and may be published in regulatory and/or technical documents.You would be responsible for technical mentoring of lab staff and sharing technical information and standard methodology within the work group and across plant sites. You would have the opportunity to participate in and influence the technical agenda of the plant.

Key Objectives/Deliverables:

  • Technical review, interpretation and release of data including Certificate of Testing issuance, stability results and reference standard characterization.

  • Contributes to Annual Product Reviews and process validations as required.

  • Interacts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements.

  • Perform technical training.

  • Coach lab analysts in real time.

  • Mentor analysts through formal process/program.

  • Review and approve 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. Writes and publishes regulatory and/or technical reports and memos.

  • Utilizes technical skills to lead or perform in-depth investigations into out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.

  • Develop investigational testing protocols and perform testing as required.

  • Method validation/verification/remediation.

  • Monitor method and process performance.

  • Research and recommend new technologies.

  • Improve lab quality systems; develop content, review and approve SOPs and training as necessary.

  • Contribute to development of Global Lab Quality Standards and implement them.

  • Comply with and implement safety standards.

  • Provide technical oversight to/for Periodic Management Reviews.

  • Communicate effectively in both written and oral formats within the lab as well as with external customers and business partners. Types of communication include:

  • Notification to management of quality issues

  • Interactions with other functions

  • Interactions with auditors

  • Participates in internal/external audits.

Req ID:

41369BR

Additional Skills/Preferences:

  • Demonstrated accuracy and proficiency in analytical skills.

  • Demonstrated strong problem-solving skills. Preferred training and demonstrated proficiency in Root Cause Investigation methodologies.

  • Strong oral and written communication skills and demonstrated through documentation and presentation skills.

  • Demonstrated strong interpersonal interaction skills.

  • Ability to focus on continuous improvement.

  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all Health, Safety and Environmental corporate and site goals.

  • Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.

  • Demonstrated proficiency in complex laboratory analysis (e.g. Microbiological, biochemical assays)

  • Deep understanding of compliance requirements and regulatory expectations.

Additional Information:

  • Tasks may require repetitive motion and standing for long periods of time.

  • 8 hour days – Monday through Friday

  • Required to be reachable off shift to respond to issues related to 24/7 manufacturing.

  • Minimal travel required.

  • 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.

Title:

Senior Microbiologist-QC Micro CoT Release

Job Category:

Quality

Basic Qualifications:

  • Bachelor (4-year College) degree in biological science field such as microbiology or biology.

  • A minimum of 7 years of proven relevant experience in a GMP lab.

  • You are legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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.

City:

Indianapolis

Country:

USA

State / Province:

Indiana

Region:

North America