Sr. Principal Chemist-QC Lab

Location: Indianapolis

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.
** Summary of Job Responsibility:
** The Sr. Principal Chemist reviews, interprets, and releases batch results for the laboratory. This role leads the design and execution of method development and validations, technology transfers, and equipment evaluation and qualification. They may perform non-routine lab work in support of those projects. They utilize their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results.  

Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented by QC-Certificate of Testing (CoT) Release and may be published in regulatory and / or technical documents. The position is responsible for technical mentoring of lab staff and sharing technical information and best practice within the work group and across plant sites. This role participates and influences the technical agenda of the plant or corporation.

** Major Accountabilities:
*** Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
* Technical review, interpretation and release of data including CoT issuance, stability results and reference standard characterization.
* Contributes to APR 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.
* Performs technical training.
* Coach to lab analysts in real time.
* Mentor's analysts through formal process / program.
* Reviews and approves change controls and deviations.
* Reviews and interprets 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 spec 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 / 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 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.
* Interacts with other functions and auditors and participates in internal / external audits.
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* Minimum Qualifications:

*** Bachelors’ Degree in a science field related to the lab in which they are placed (e.g. chemistry for chem labs or micro or biology for micro lab); advanced degree (MS or PhD) desired.
* Minimum 7-10 years of demonstrated relevant experience in a GMP lab.
** Additional Information:
*** Demonstrated accuracy and proficiency in analytical skills.
* Demonstrated strong problem - solving skills.
* Preferred training and demonstrated proficiency in Root Cause Analysis methodology.
* Demonstrated experience in coaching and mentoring others.
* Strong oral and written communication skills and…