Consultant Chemist-Qual CoT Rel

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. Were looking for people who are determined to make life better for people around the world.

Summary of Job Responsibility:
The QC-CoT Release 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-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 others 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 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
• Interact with other functions and auditors
• Participates in internal / external audits.

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)

• 7 - 10 years of demonstrated relevant experience in a GMP lab . Bachelor's degree in science or related field preferred, advanced degree (MS or PhD) desired

• Demonstrated accuracy and proficiency in analytical skills
• Demonstrated strong problem - solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology
• Strong oral and written communication skills and demonstrated through documentation and presentation skills
• Demonstrated strong interpersonal interaction skills
• Ability to focus on continuous improvement

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidates education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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