Lilly
Sr. Principal Scientist - QC - CoT
Lilly, Lebanon, Indiana, United States, 46052
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 is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
Position Description:
The Principal, Senior Principal, Advisor or Senior Advisor Scientist - QC - CoT Release reviews, interprets, and releases batch results for the laboratory. They lead 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 the Principal, Senior Principal, Advisor or Senior Advisor Scientist - 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. They participate and influence the technical agenda of the plant or corporation.
In addition, the Scientist-QC will provide technical support to QC operations as part of the organization’s off-hours support strategy.
Key Objectives/Deliverables:
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.
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 recurrence.
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.
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.
Basic Requirements:
Bachelors’ Degree in a science field related to the lab in which they are placed (e.g. chemistry for chem labs or microbiology, biology, or biotechnology for micro labs)
7+ years of demonstrated relevant experience in a GMP lab.
Additional Preferences:
Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic and / or microbiological assays
Deep understanding of compliance requirements and regulatory expectations.
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
Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Additional Information:
Strong potential for a Short-Term Assignment in Kinsale, Ireland in 2025 for approximately six months.
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 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.
#WeAreLilly
#J-18808-Ljbffr
Organization Overview:
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
Position Description:
The Principal, Senior Principal, Advisor or Senior Advisor Scientist - QC - CoT Release reviews, interprets, and releases batch results for the laboratory. They lead 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 the Principal, Senior Principal, Advisor or Senior Advisor Scientist - 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. They participate and influence the technical agenda of the plant or corporation.
In addition, the Scientist-QC will provide technical support to QC operations as part of the organization’s off-hours support strategy.
Key Objectives/Deliverables:
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.
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 recurrence.
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.
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.
Basic Requirements:
Bachelors’ Degree in a science field related to the lab in which they are placed (e.g. chemistry for chem labs or microbiology, biology, or biotechnology for micro labs)
7+ years of demonstrated relevant experience in a GMP lab.
Additional Preferences:
Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic and / or microbiological assays
Deep understanding of compliance requirements and regulatory expectations.
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
Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Additional Information:
Strong potential for a Short-Term Assignment in Kinsale, Ireland in 2025 for approximately six months.
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 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.
#WeAreLilly
#J-18808-Ljbffr