What are the responsibilities and job description for the Sr. Principal - Global Quality Labs position at Lilly?
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 35,000 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.
Organization Overview:
Global Quality Labs (GQL) is a center of excellence for analytical stewardship, method life cycle management (development/validation/transfer and troubleshooting), technology transfer and analytical troubleshooting. Our responsibilities include analytical/technical support for Lilly manufacturing sites, and external partners, as well as the development and clinical areas.
The Sr. Principal Scientist, GQL is accountable for ensuring consistent analytical testing of product at multiple sites in accordance with external guidance and approved Lilly specifications. The Sr. Principal Scientist, GQL, collaborates for commercialization of methods and is responsible for sustaining the methods for in-process, active pharmaceutical ingredients, and drug product throughout the lifecycle of the asset.
Responsibilities:
The Sr. Principal Scientist, GQL will be responsible for:
Being an individual contributor with technical expertise in analytical chemistry
Coordination and/or execution of activities with other chemists and leading and/or participating as an integral part of multidisciplinary teams.
Providing analytical support, project leadership, and/or technical direction, and perform laboratory analyses as needed for technical or analytical operational projects while defining and balancing priorities.
Conducting method assessments for commercialization and compendial method installation.
Oversight of post-commercialization method development/optimization and implementation of method improvements - including laboratory work, training/transfers, change controls, and regulatory submissions.
Assessment of method validations for commercialization and leadership/execution of method validations post-commercialization.
Definition and/or review of reference standard re-evaluation protocols.
Designing, participating in, and/or coordinating method transfers between Lilly QC Labs and Third Party Organizations
Ensuring accuracy of submission for new monographs.
Defining and sustaining consistent practices among global laboratories.
Mentoring technical talent.
Basic Qualifications:
Bachelors degree in Chemistry or related field.
Minimum of 5 years industry experience working with method development, optimization, validation, and remediation in GMP analytical testing laboratories.
Additional Skills/Preferences:
Masters or Doctorate in Chemistry, Biochemistry, Pharmacy, or equivalent experience; industry related experience in pharmaceuticals is preferred.
Previous experience with Lilly deviation and change control process.
Ability to influence diverse groups and effectively manage relationships,
Thorough technical understanding of the quality systems and regulatory requirements,
Experience in root cause analysis.
Additional Information:
The Sr. Principal Scientist, GQL must complete Training Plan for the analytical chemist.
Some travel (up to 20%) may be incurred.
Must be capable of handling Drug Enforcement Agency (DEA) Scheduled Controlled Substances (i.e., must be able to be authorized).
This position has potential to exist at a host site.
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 ( [ Email address blocked ] - Click here to apply to Sr. Principal - Global Quality Labs ) 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
\#WeAreLilly
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.? We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
\#WeAreLilly
Organization Overview:
Global Quality Labs (GQL) is a center of excellence for analytical stewardship, method life cycle management (development/validation/transfer and troubleshooting), technology transfer and analytical troubleshooting. Our responsibilities include analytical/technical support for Lilly manufacturing sites, and external partners, as well as the development and clinical areas.
The Sr. Principal Scientist, GQL is accountable for ensuring consistent analytical testing of product at multiple sites in accordance with external guidance and approved Lilly specifications. The Sr. Principal Scientist, GQL, collaborates for commercialization of methods and is responsible for sustaining the methods for in-process, active pharmaceutical ingredients, and drug product throughout the lifecycle of the asset.
Responsibilities:
The Sr. Principal Scientist, GQL will be responsible for:
Being an individual contributor with technical expertise in analytical chemistry
Coordination and/or execution of activities with other chemists and leading and/or participating as an integral part of multidisciplinary teams.
Providing analytical support, project leadership, and/or technical direction, and perform laboratory analyses as needed for technical or analytical operational projects while defining and balancing priorities.
Conducting method assessments for commercialization and compendial method installation.
Oversight of post-commercialization method development/optimization and implementation of method improvements - including laboratory work, training/transfers, change controls, and regulatory submissions.
Assessment of method validations for commercialization and leadership/execution of method validations post-commercialization.
Definition and/or review of reference standard re-evaluation protocols.
Designing, participating in, and/or coordinating method transfers between Lilly QC Labs and Third Party Organizations
Ensuring accuracy of submission for new monographs.
Defining and sustaining consistent practices among global laboratories.
Mentoring technical talent.
Basic Qualifications:
Bachelors degree in Chemistry or related field.
Minimum of 5 years industry experience working with method development, optimization, validation, and remediation in GMP analytical testing laboratories.
Additional Skills/Preferences:
Masters or Doctorate in Chemistry, Biochemistry, Pharmacy, or equivalent experience; industry related experience in pharmaceuticals is preferred.
Previous experience with Lilly deviation and change control process.
Ability to influence diverse groups and effectively manage relationships,
Thorough technical understanding of the quality systems and regulatory requirements,
Experience in root cause analysis.
Additional Information:
The Sr. Principal Scientist, GQL must complete Training Plan for the analytical chemist.
Some travel (up to 20%) may be incurred.
Must be capable of handling Drug Enforcement Agency (DEA) Scheduled Controlled Substances (i.e., must be able to be authorized).
This position has potential to exist at a host site.
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 ( [ Email address blocked ] - Click here to apply to Sr. Principal - Global Quality Labs ) 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
\#WeAreLilly
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.? We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
\#WeAreLilly
Recommended Skills
- Analytical Chemistry
- Assessments
- Biochemistry
- Business Management
- Change Control
- Chemistry
Salary : $34,281 - $43,937
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